McGlashan

et al. Pilot and Feasibility Studies (2023) 9:88 Pilot and Feasibility Studies
https://doi.org/10.1186/s40814-023-01317-y

STUDY PROTOCOL Open Access

A mixed-method feasibility study of the use of

the Complete Vocal Technique (CVT), a
pedagogic method to improve the voice and
vocal function in singers and actors, in the
treatment of patients with muscle tension
dysphonia: a study protocol
Julian McGlashan1* , Mathias Aaen2,3, Anna White1 and Cathrine Sadolin2,3

Abstract
Background Muscle tension dysphonia (MTD) results from inefficient or ineffective voice production and is the
cause of voice and throat complaints in up to 40% of patients presenting with hoarseness. Standard treatment is
voice therapy (SLT-VT) delivered by specialist speech therapists in voice disorders (SLT-V). The Complete Vocal
Technique (CVT) is a structured, pedagogic method which helps healthy singers and other performers optimise their
vocal function enabling them to produce any sound required. The aim of this feasibility study is to investigate
whether CVT administered by a trained, non-clinical CVT practitioner (CVT-P) can be applied to patients with MTD
before progressing to a pilot randomised control study of CVT voice therapy (CVT-VT) versus SLT-VT.
Methods/design In this feasibility study, we use a mixed-method, single-arm, prospective cohort design. The
primary aim is to demonstrate whether CVT-VT can improve the voice and vocal function in patients with MTD in a
pilot study using multidimensional assessment methods. Secondary aims are to assess whether (1) a CVT-VT study
is feasible to perform; (2) is acceptable to patients, the CVT-P and SLT-VTs; and (3) whether CVT-VT differs from
existing SLT-VT techniques. A minimum of 10 consecutive patients with a clinical diagnosis of primary MTD (types I–
III) will be recruited over a 6-month period. Up to 6 video sessions of CVT-VT will be delivered by a CVT-P using a
video link. The primary outcome will be a change in pre-/post-therapy scores of a self-reported patient
questionnaire (Voice Handicap Index (VHI)). Secondary outcomes include changes in throat symptoms (Vocal Tract
Discomfort Scale), acoustic/ electroglottographic and auditory-perceptual measures of voice. Acceptability of the
CVT-VT will be assessed prospectively, concurrently and retrospectively both quantitatively and qualitatively.
Differences from SLT-VT will be assessed by performing a deductive thematic analysis of CVT-P transcripts of
therapy sessions.
Conclusion This feasibility study will provide important data to support whether to proceed with a randomised
controlled pilot study focusing on the effectiveness of the intervention compared to standard SLT-VT. Progression
criteria

*Correspondence:
Julian McGlashan
[email protected]
Full list of author information is available at the end of the article

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 2 of 18
© Crown 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit
to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The
images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated
otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory
regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco
mmons. org/ licen ses/ by/4. 0/. The Creative Commons Public Domain Dedication waiver (http:// creat iveco mmons. org/ publi cdoma in/ zero/1. 0/) applies to the data
made available in this article, unless otherwise stated in a credit line to the data.
will be based on demonstrating a positive outcome in treatment, successful delivery of the pilot study protocol,
acceptability to all stakeholders and satisfactory recruitment rates.
Trial registration ClinicalTrials.gov website (NCT05 365126 Unique Protocol ID: 19ET004). Registered on 06 May
2022.
Keywords Muscle tension dysphonia, Voice therapy, Feasibility study, Telehealth
Background Standard treatment of MTD
Hoarseness and associated vocal problems (dysphonia) Traditional treatment of MTD consists of indirect voice
cause both a major impact on quality of life and livelihood therapy and direct voice therapy [20] given by a speech
for affected patients as well as posing a substantial and language therapist specialised in voice disorders (SLT-
healthcare burden [1]. Approximately 40% of patients V) [21, 22]. Indirect voice therapy consists of education,
referred for assessment of hoarseness will be diagnosed information, vocal hygiene and psychological support to
with primary muscle tension dysphonia (MTD), a encourage behavioural change [23] whereas direct voice
condition causing voice impairment and/or reduced vocal therapy consists of establishing healthy voice production
capacity in the absence of known structural, neurological [24, 25] by rebalancing the three subsystems of voice
or inflammatory laryngeal pathology [2, 3]. Other production namely breathing (respiration), voice
symptoms of MTD may include vocal fatigue, vocal production (phonation) and more efficient use of
strain, aberrant pitch and pitch range, variability in the resonance [8, 26, 27]. Direct voice therapy however is not
quality or control of voice, difficulties in voice projection, just one treatment method, and many SLTVs use a
reduced vocal stamina and vocal tract discomfort [4]. hierarchical and experiential approach drawing on
Primary MTD is thought to arise from dysregulated or multiple techniques but often with limited evidence to
imbalanced laryngeal and para-laryngeal muscle activity support their adoption [28]. Problematically, voice therapy
due to dysfunctional prefrontal cortical regulation that has been portrayed as a ‘black box; and many recognised
may interfere with laryngeal motor preparation, initiation treatment regimens overlap in their aims and therapeutic
and execution combined with heightened input from goals with often limited descriptions of ‘active
limbic regions [2, 5, 6]. This results in excessive ingredients’ [20, 28, 29]. In addition, outcome measures
contraction of extrinsic laryngeal, suprahyoid and/or strap are used inconsistently and there are limited reports on
muscles which tend to elevate the suspended hyoid-larynx treatment fidelity [28]. This makes it difficult to determine
complex and in turn sympathetically induces intrinsic why patients improve, which therapy tasks are most
laryngeal hyperfunction [7]. This laryngeal hyperfunction beneficial and for how long they should be given [20, 28,
is often associated with dysfunctional breathing patterns 30–33]. There are also few studies looking at the long-
and use of resonance [8]. Secondary MTD is term benefits of all voice therapy modalities [7].
compensatory behaviour to overcome organic pathology
[9]. There is no objective diagnostic test for MTD. A
diagnosis of primary MTD is usually made on (1) clinical
history, presenting symptoms and voice quality; (2)
absence of organic pathology and (3) the appearance of
the larynx on laryngostroboscopy [6, 10]. Although
numerous classifications of MTD have been described in
the past, six recognisable patterns of primary MTD are
often described [6, 11, 12]. Three types (MTD patterns I–
III) are more related to ineffective voice use, also known
as ‘voice abuse’ or ‘voice misuse’, which will be the focus
of this study (Fig. 1). The other three types (MTD patterns
IV–VI) have a predominantly psychological basis [13– 18]
although personality and/or psychological issues may also
contribute to perpetuation of abnormal MTD patterns in
types I–III in some cases [19].

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 3 of 18
Use of the complete vocal technique in vocal performers The
complete vocal technique (CVT) is pedagogic technique
primarily used by singing teachers and vocal coaches to
aid singers and actors produce the vocal sound and vocal
function that the performer requires [34] and has been
used for over 35 years, particularly in Europe. CVT
practitioners (CVT-P) undergo an accredited 3-year
training programme to achieve competency. CVT uses a
systematic approach with terminology that is clearly
defined and supported with scientific characterisation
[35–38]. Specific elements of CVT have been packaged

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

Fig. 1 Endoscopic appearance of the larynx demonstrating MTP patterns types I–III
McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 4 of 18
together in what is termed CVT voice therapy (CVT-VT) knowledge, there has been no evaluation of singing
which is used for performers presenting with acute vocal instruction, including CVT, given by a video link to
problems. Although CVT-VT has been used primarily to performers delivered by vocal coaches.
improve or rehabilitate the singing voice it has also been Potential benefits and harm of using CVT-VT in MTD patients
used to help the performing speaking voice but not in a Vocal performers need rapid return to professional vocal
patient population. In addition, there have been no studies function to avoid loss of employment, income and
on CVT-VT and no comparison has been made between reputation. CVT-VT is used by CVT-P’s for this purpose
standard SLT-VT and CVT-VT techniques. It is unclear but there is only anecdotal evidence of its effectiveness in
what, if any, differences there are in the ingredients and the acute situation. CVT-VT has the potential benefit of
targets [39]. providing rapid improvement in MTD patients as it is
based on a well-defined, systematic assessment and
Use of a video link for delivery of therapy and instruction evaluation protocol [34]. There is no evidence that
Traditionally, voice therapy for patients, and CVT training patients come to serious harm from SLT-VT interventions
for performers, has been given face-to-face. However, for MTD or singers from CVT-VT, but to our knowledge,
with the onset of the COVID-19 pandemic, SLT-VT and there are no studies addressing this specific issue. A small
CVT training have almost entirely been given using longitudinal study of the vocal health of twenty singers
telehealth via a video link [40]. There are few randomised using CVT over 14 years however did not show any
controlled studies comparing face-to-face versus detrimental effects [42]. Adverse outcomes with SLT-VT
telehealth for voice disorders, and only one study in MTD are mostly reported as ‘no improvement’, ‘non-
patients, which showed no significant difference in compliance’ or patient ‘drop-out’ [7], and it is possible the
outcome between the two methods of delivery [41]. To our same may apply to patients treated with CVT-VT.
Rationale and aims for the study Participants and setting of the study
Patients with MTD and vocal performers both present Patients referred by Primary Care Physicians to the Ear, with
voice impairment and/or reduced vocal capacity Nose and Throat (ENT) Department, Queen’s Medical due to
dysregulated or imbalanced laryngeal and para- Centre Campus (QMC), Nottingham University Hoslaryngeal muscle
activity associated with dysfunctional pitals, with hoarseness will be screened and those with breathing patterns and
inefficient use of resonance dur- a clinical diagnosis of MTD will be reviewed in a joint ing phonation. CVT-VT
administered by appropriately voice clinic in the ENT Department, for more specialtrained practitioners provides a well-
described tool that ist assessment. A diagnosis of primary MTD will be could potentially be used to restore vocal
function in made by consensus between an experienced laryngoloMTD patients. Although CVT-P’s are highly trained,
gist and SLT-VT following detailed medical evaluation their clientele are largely healthy vocal performers and including
laryngostroboscopic examination. Consecutraditionally they refer clients with unhealthy voices for tive patients with a
confirmed diagnosis of MTD due clinical assessment and treatment. The aim of this fea- to ’voice abuse/misuse’ (Table
1) who meet the inclusibility study is to address the following uncertainties sion (Table 2) and exclusion criteria will be
invited to before proceeding with a pilot randomised clinical trial of take part in the study and at least 10 will be
recruited CVT-VT versus SLT-VT: (1) Can CVT-VT applied by a (Fig. 2).
CVT-P improve the voice and vocal function in patients
with MTD? (2) Is it feasible to perform a pilot study using Recruitment and consent
CVT-VT administered by a CVT-P using telehealth? (3) Recruitment voice clinic
Is CVT-VT acceptable to patients, CVT-Ps and SLT-VTs? All patients attending the voice clinic in the ENT depart(4)
Does CVT-VT offer a new approach to improving the ment at NUH will be assessed by a laryngologist and voice and
vocal function compared to traditional SLT-VT SLT-VT and have a nasoendoscopic laryngostroboscopic methods?
Progression criteria will use the traffic light examination prior to recruitment to rule out organic system [ 43, 44] and be
based on demonstrating a positive pathology and confirm the pattern of muscle tension outcome in treatment,
acceptability to all stakeholders dysphonia. Patients identified as having primary MTD and successful delivery of the
pilot study protocol. seen will have their eligibility checked and given a patient information sheet outlining the study.
They will be con-
Methods tacted by phone after their clinic appointment to see if
Study design they are willing to consent to taking part. Those inter-
This prospective feasibility study [45] of CVT-VT for ested will be invited to attend a research clinic run by the MTD
has a mixed-method, non-randomised, single- study laryngologist and SLT-VT. Those who decline will arm design. It
will be conducted in a tertiary voice be referred on the standard SLT voice therapy pathway. centre in Nottingham, UK.
The study protocol has

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 5 of 18
been approved by the NHS Health Research Authority Research clinic and consent
(HRA) and Health and Care Research Wales (HCRW) Patient eligibility will be checked, and written consent (14 April
2022) following favourable Ethical opin- obtained. Study questionnaires including a goal-setting ion for conduct by the
East of England—Cambridge checklist will be completed. Acoustic and EGG recordSouth Research Ethics Committee
(Reference no. 22/ ings will be made including MPT and the case-report EE/0047). The study will be reported in
accordance form (CRF) completed. Prior to commencing therapy, with the CONSORT extension to pilot studies [46] all
participants will be given indirect voice therapy in and SPIRIT guidelines [47] as outlined in Thabane the form of a
vocal hygiene advice leaflet (see Additional et al. [48]. file 1) when they attend the Research clinic. A post-visit

Table 1 Symptoms and clinical findings compatible with a clinical diagnosis of MTD

•The history of the presentation of the condition and its compatibility with a Primary MTD diagnosis
•Presenting vocal symptoms such as hoarseness, change in voice quality, limitations in pitch, loudness, flexibility, and/or stamina of the voice
•Absence of organic pathology such as structural abnormalities, neurological and inflammatory conditions on endoscopy
•Auditory-perceptual voice change which includes one or more of the following characteristics: having a variable or abnormal in quality (overall
severity of hoarseness, roughness, breathiness, strain), having an abnormal habitual pitch with or without a restricted fundamental speaking
frequency range or having abnormal loudness and loudness variability during speech
•The presence of muscle soreness, tenderness or other evidence of hyperfunction in the thyrohyoid or cricothyroid space and/or suprahyoid
muscles on physical examination
•Laryngoscopic findings of laryngeal hyperfunction pattern (MTP types 1–III)
Table 2 Inclusion and exclusion criteria check of the participant’s video link will be made prior to
the start of the therapy sessions. Following completion of
Inclusion criteria the CVT-VT, participants will be asked to attend a further
•Males and females Research Clinic appointment for post-therapy assessment
•18 or above (t = 8), feedback on their experience, and whether goals
•Clinical diagnosis of primary MTD based on history and laryngoscopic for treatment were met. Should further therapy be
assessment (type I–III MTD patterns) through joint assessment by a SLT- required, this will be arranged in the form of standard
V and laryngologist
SLT-VT.
•Current voice problems, persistent for greater than 2 months
•Severity of disorder (a) VHI ≥ 30 and (b) patient wants therapy
Interventions CVT-VT
•Patient willingness to undergo treatment sessions
•Agree to undertake the study protocol The therapy provided will be reported in accordance with
Exclusion criteria the TIDieR guidelines [49]. Patient contact details will be
•Organic vocal pathology (1) structural/neoplastic disorders (e.g. passed on to the CVT-P who will make contact with the
carcinoma, cyst, polyp, papilloma, Reinke’s oedema), (2) neurological
disorders (e.g. vocal cord palsy, paresis, spasmodic dysphonia) and (3)
patient by email or mobile to arrange video therapy
inflammation (e.g. infection, reflux (RFS > 7) or significant relevant sessions. These will be conducted using the NUH Trust-
systemic disease (e.g. severe COPD) or need for surgery approved platform DrDoctor. Prior to the first therapy, the
•Significant psychological issues identified during initial assessment CVT-P will review all the patient information (summary
(with option to withdraw if discovered during the treatment periods and case history and clinical findings, voice and EGG
agreed by both patient and therapist)
recordings, and laryngostroboscopic video recordings). Up
•MTD pattern (IV–VI) compatible with significant primary psychological
to 6 forty-five-minute therapy sessions will be arranged
aetiology on laryngoscopy
between the CVT-P and patient within an 8-week period.
•Transgender voice issues
•Previously incompletely treated dysphonia, neurological disease or
An additional 15 min/session will be allowed for resolving
upper aerodigestive tract malignancy connection, technical, patient and therapist attendance
•Had previous VT or CVT training or pharmacological treatment for issues.
their voice problem (other than proton pump inhibitors or an alginate
recommended for disorders of laryngopharyngeal reflux–related CVT-VT healthcare intervention
symptoms) The therapy will consist of exercises to learn sufficient
•A hearing impairment that would prohibit or impact on telepractice control over the support system, exercises for obtaining
treatment
prototypical phonation types based on the volume and
•Significant concomitant health problems affecting voice
quality requirements from the patient, along with
•Not have or be able to use a computer with video link at home or in
hospital even with support
additional exercises for dynamic control over loudness,
•Not able to commit to the study protocol colouring of voice and for expressivity. The therapy uses a
systematic building of skills starting with voiceless
support exercises, progressing to the ability to connect

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 6 of 18
support to sustained vowels, towards speech and voicing Moreover, patients will be asked to maintain the exercises
tasks including pitch change and consonants, building into between therapy sessions, with the CVT-P inquiring about
phrases and sentences. Dependent on the patient’s progress between sessions at initiation of every therapy
symptoms, goals and desired sound character(s), specific session. The outline of the therapy sessions is listed in
exercises for appropriate and healthy use of the CVT Additional file 2.
specific vocal modes that correspond to the desired
loudness and quality will be chosen. For low volume or Objectives and outcomes
breathy voice symptoms, a more twanged and more The primary aim of this study is to demonstrate that CVT-
intentionally narrowed epilaryngeal space is sought. For VT is beneficial to patients with primary MTD. Secondary
hyperfunction symptoms, adjustments in either breath aims include (1) whether it is feasible to perform a pilot
control or releasing of unintentional constriction is sought study using CVT-VT administered by a CVT-P using
to counter the hyperfunction and related pressed voice. telehealth; (2) whether CVT-VT is acceptable to patients,
the CVT-Ps and SLT-VTs; and (3) whether CVT-VT
differs from SLT-VT. The outcomes will provide
important evidence for the feasibility of planning a larger
pilot randomised controlled trial focusing on the
effectiveness of the intervention compared to standard
SLT-VT.
Primary aim: does CVT-VT delivered by a CVT-P improve the
voice and vocal function in patients with primary MTD?
This question will be addressed using a prospective, non-
randomised, single-arm pilot study using a range of
multidimensional measures. The study will also test the utility
of some of these measures in this patient population by
measuring changes in pre- and post-treatment values and
provide initial data for the primary outcome measure, to help
determine a sample size calculation for a larger trial [50].
Treatment improvement will form one aspect of the
evaluation of feasibility to use CVT-VT delivered by a CVT-P
to treat patients with muscle tension dysphonia. The objectives
are to determine whether CVT-VT is beneficial in the
treatment of patients with primary MTD using both patient-
rated and physician-measured outcome measures to give a
multidimensional assessment of voice and vocal function
outcome pre- and posttreatment. Although there is general
agreement on some outcome measures such as patient self-
evaluation questionnaires, there is less consensus on the
auditory-perceptual and objective measures of voice such as
acoustic, electroglottographic (EGG) and aerodynamic
measures.
The patient measures will include two validated disease-
specific patient self-evaluation questionnaires the Voice
Handicap Index [39, 51] and the Vocal Tract Discomfort Scale
[42]. These measures assess a range of psychosocial, physical
voice impairment symptoms, the ability to be heard and throat
symptoms [52]. As this study is designed to determine
feasibility rather than effectiveness, an improvement in the
median score of the VHI of > 20% for the group will be taken
as a positive outcome. The physician measures will include a
range of acoustic, electroglottographic (EGG) and
aerodynamic measurements as well as an auditory-perceptual
evaluation of the voice using the CAPE-V rating scale [53].
Primary outcome measure: Voice Handicap Index (VHI)
Patient-reported outcomes are generally accepted as the most
relevant tool for evaluating treatment effectiveness of voice

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 7 of 18
disorders as they may provide a more a more meaningful impact overall of a voice disorder [52, 54]. Of these, the
validated VHI [51] has been shown to have one of the best psychometric properties among voice-specific quality of
life instruments [55, 56] and will be the primary outcome measure for this study. The VHI has been validated with
strong internal consistency and test–retest reliability and has been used as a functional outcome measure from
behavioural voice treatment in clinical practice and in clinical research which allows cross-study
Fig. 2 Flow chart (V2.0 28 Feb 2023) comparisons of treatment response [51, 57–60]. VHI scores can range from 0 (no
‘handicap’) to 120 (maximal ‘handicap’), with scores below
30 generally associated
with minimal ‘handicap’. Thirty was one of the eligibility mouth. The synchronous EGG signal will be recorded
criteria used for the study. Changes in VHI scores of 18 from two electrodes placed on either side of the larynx of
points or greater from pre-treatment to post-treatment the subject and inputted into the laryngograph
have been reported to indicate a meaningful clinical effect microprocessor. The signals will be processed using
[51]. Speech Studio software program (vers. 5.21.
Laryngograph® Ltd.) and saved as . wav files. The recordings
Vocal tract discomfort scale (VTDS) will then be analysed using the in-built statistical
Although voice problems are the most common presenting programs and into the computer program Praat [66] (Paul
complaint in patients with MTD, many have associated Boersma & David Weenink, Institute of Phonetic
symptoms of vocal tract discomfort [53]. It is thought Sciences, University of Amsterdam, the Netherlands;
these relate to increased vocal effort and vocal fatigue [53, http:// www. praat. org/).
61, 62]. The VTDS is a validated self-administrated The following voice parameters based on EGG and
questionnaire designed to measure the subjective acoustic measures reflecting different aspects of vocal
perception of sensory discomfort in the throat (vocal tract) function will be assessed:
[53]. Patients are asked to rate the frequency of occurrence
and severity manifestation of eight subjectively different 1) Sustained vowels
sensations: burning, tightness, dryness, aching, tickling,
soreness, irritability and lump in the throat. The frequency Acoustic and EGG signals recordings will be made of
and severity are rated separately on a seven-point Likert the four English corner vowels as in the words: /i:/ as in
scale ranging from 0 to 6 for frequency (0 = never, 2 = feet, /u:/ as in food, /æ/ as in fad, /α:/ as in farm. They will
sometimes, 4 = often, 6 = always) and for severity (0 = be analysed using the multidimensional voice pro-
none, 2 = mild, 4 = moderate, 6 = extreme) [63]. VTDS
scores have been shown to correlate with the total and
file (MDVP) analysis programme in Speech Studio (vers.
physical domain score of the VHI and decrease after voice
5.21. Laryngograph® Ltd.) [67]. The multidimensional
training and vocal hygiene education in teachers [64]. A
measures will include the average fundamental frequency
change in the Persian version of the VTDS of 6.0 points
(Fx), average vocal fold contact quotient (Qx) and mean
for each subscale following a therapeutic intervention has
sound pressure level (mean SPL); a range of perturbation
been interpreted as a real change with a 95% confidence
measures (standard deviation of the fundamental
level [65]. Again an improvement in the median score for
frequency (SD of Fx), standard deviation of the contact
the group will be taken as a positive outcome. Acoustic and
quotient (SD of Qx), jitter factor, shimmer dB, cepstral
EGG measures
peak prominence (CPP), relative amplitude perturbation
Pre- and post-treatment acoustic and EGG measurements
(RAP)); and measurements of spectral noise energy versus
during phonation provide an objective assessment of the
harmonic energy (normalised noise energy (NNE),
different aspects of the voice and vocal function at
harmonics to noise ratio (HNR)) [67]. Spectral energy
specific points in time. There are no universally agreed
measurements have been reported to be the most
parameters to measure and so it is common for a range of
correlated acoustic measure with perceptual judgments of
individual and combined multidimensional parameters to
roughness, breathiness and hoarseness. It is hypothesised
be extracted from both sustained vowels and read text.
that perturbation and spectral noise energy versus
The quality and standardisation of the recordings is
harmonic energy measures will improve following
important to avoid measurement error. To that end, the
therapy.
acoustic and EGG measures will be recorded in a
The Praat computer program will be used to calculate
treatment room, which exhibits nominal ambient room
CPPS, the AVQI and H1-H2 ratio from the recordings
noise. The recordings will be made at the time of the
[66]. Unidimensional cepstral acoustic measures such as
research clinic appointments (t = 0, t = 8) using a head-
cepstral peak prominence (CPP) [68] and smoothed CPP
mounted omnidirectional microphone placed
(CPPS) [69] have been used as reliable predictors for
approximately 3 cm from the left side of the corner of the
dysphonia with values reducing as dysphonic severity

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 8 of 18
increases [70]. It has been found to have better sensitivity, [67]. A range of statistical measures based on EGG and
specificity, and positive and negative predictive values
acoustic measures of connected speech in Speech Studio ™
than jitter, shimmer and NHR. CPP is the prominent peak
with the highest amplitude representing the fundamental describe different aspects of vocal fold vibration and
frequency. CPPS has also been shown to be a good function [67, 80]. These include the following:
measure of vocal fatigue in patients with hyperfunctional
voice disorders [71]. Acoustic measurement of smoothed • Mode speaking fundamental frequency (Fx) (Hz) +
cepstral peak prominence (CPPS will be made on the coherence %
stabilised 1 s mid-portion of sustained /a/ vowel • Mode Loudness level (Ax) (dB) + 80% dB range +
(CPPs-/a/) and the CAPE-V voice phrase ‘We were away a coherence %
year ago’ phrase (CPPS-s). • Mode contact quotient (Qx) % + 80% contact %
In addition, the mean level difference in decibels (dB) range + coherence %
between the first and second harmonics (H1-H2) of all • Irregularity scores Fx, Ax, Qx (%)
voiced segments will be measured for the vocal tasks. H1- • Speech range profile (80%)
H2 is a low-bandwidth measure of spectral tilt that ◦ 80% minimum and maximum intensity (dB)
provides an estimate of vocal fold closure during ◦ 80% maximum—minimum frequency range
phonation [72]. Less abrupt/reduced vocal fold closure converted to Semitones (Semitone range)
associated with a breathier voice quality is reflected in
larger differences between the two harmonics (higher H1–
H2); conversely more abrupt or increased vocal fold 4) Sustained vowels and vowels from speech samples:
closure is associated with a more strained voice quality acoustic formant frequency measures of vocal tract
and smaller differences between the two harmonics (lower length and formant space
H1–H2) [73–75]. H1-H2 differences could therefore
provide an additional measure of change in glottal contact There is radiographic evidence that individuals with
in response to therapy [76]. vocal hyperfunction exhibit a significantly higher
laryngeal position and reduced hyolaryngeal space with
2) The sentence “We were away a year ago” (from consequent shorter vocal tract lengths (VTL) than
CAPE-V) individuals with healthy voices [81–83]. Raising of the
larynx is a consequence of increased extrinsic laryngeal
Other comparative pre- and post-treatment spectral muscle activation, specifically, activation of the
analyses will also be performed using long-term average thyrohyoid, digastric, stylohyoid, mylohyoid, geniohyoid,
spectra (LTAS). LTAS is a fast Fourier transform- hyoglossus and/ or genioglossus muscles [84]. Changes in
generated power spectrum of the frequencies comprising a VTL cause a change to all formant frequencies, with a
speech sample. Thus, the LTAS is a composite signal shorter VTL corresponding to increased formant
representing the spectrum of the glottal source as well as frequencies [82, 85, 86]. A simple relationship between
the spectrum or resonant characteristics of the vocal tract. VTL and formant frequency can be derived by modelling
LTAS holds promise as an acoustic index of voice quality the vocal tract as a uniform tube that is closed at one end
[77]. For example, relatively weak harmonic energy in the and open at the other, which exhibits odd quarter-wave
higher frequencies of the speech spectrum and a harmonic resonances [86, 87]. More reliable estimates can
corresponding increase in spectral tilt are characteristic of be made using higher formant frequencies (F3 and F4) as
breathy or hypo-functional signals [68, 78]. In contrast, they are more stable [88, 89]. A high larynx can lead to
excessive vocal fold impact and turbulent noise, both of restricted tongue movements and vocal tract shaping
which have been noted in functional dysphonia, are which can impact on clarity of vowel formation (balance
associated with relatively greater energy in the higher between F1 and F2 formants). It has been shown that
frequencies of the speech spectrum [79]. The Sentence formant frequencies for corner vowels are dependent on
“We were away a year ago” features all voiced phonemes multiple subject and phonetic context factors [84] but
and provides a context to judge possible voiced within subject changes secondary to therapy for example
stoppages/spasms and one’s ability to maintain voicing could be potentially detectable if all other factors are kept
from one word to another [64]. constant. Changes in the formant frequencies from the
sustained vowels and from the extracted corner vowels
3) A passage of read text ‘Arthur the Rat’ from stable parts of the read passage (‘Arthur the rat’) will
be compared pre- and post-therapy.
It has been argued that connected speech is a better
reflection of vocal function compared to sustained vowels 5) Happy birthday to you

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 9 of 18
This song has been chosen as it is one of the most 2) CVT speech therapy assessment rating (CVT-STAR)
widely recognised songs in the English language.
However, it is technically quite difficult for non-trained The CVT speech assessment rates three overall
singers as it has a high note, an octave higher, (or seven parameters: (1) descriptive technical parameters, (2)
note jump in the musical scale) than the starting note and additional speech parameters and (3) parameters for
small intervals that are near each other. Although reaching detecting issues (see Additional file 3). All parameters are
the top note does depend on the starting note, it is a rated on a 3-point scoring. The scale ratings are 0 = not at
reasonably good measure of the flexibility of the voice. all, 1 = mild, 2 = moderate and 3 = a lot/much. Any speech
The proposal is to perform acoustic and EGG recordings assessment involves at least (1) the technical parameters
whilst singing the four lines. Each line will be analysed for and (3) the detection of issues. The additional speech
changes in the LTAS spectral slopes pre- and post- parameters (2) are assessed if deemed necessary by the
treatment. Auditory-perceptual evaluation CVT-P. The three parameters are and include the
Auditory-perceptual evaluation of voice by expert trained following:
listeners is a subjective judgment on the type and severity
of the dysphonic quality present [90]. No auditory- a) Descriptive technical parameters include
perceptual rating is perfect [91, 92], but CAPE-V is descriptions of mode of vibration (mainly), the
widely used in both the clinical and research settings as it amount of metallic character in the voice, the degree
provides a finer judgement of voice quality than the four- of density in the voice and the chosen vocal mode
point ordinal scale used in GRBAS [93]. CVT have and vocal mode variation, whether the speaker is
developed their own speech assessment rating using CVT- within the centre of the chosen vocal mode, to what
specific terminology and will also be used. degree there are vocal effects present, to what degree
there are rough vocal effects present and degrees of
1) CAPE-V voice instabilities and degree of strain.
b) Additional speech parameters include rating of
The Consensus Perceptual Auditory Evaluation of Voice sound colour, amount of twang, the speed of speech,
(CAPE-V) is a standardized clinician-made auditory- the pitch, pitch variation, accentuation/stressing of
perceptual measurement of voice that provides an overall words, volume and size of the larynx.
rating of severity as well as discreet ratings of specific c) Parameters for detecting issues include rating the
vocal parameters including overall severity, roughness, degree of support energy/effort, the degree of
breathiness, strain, pitch and loudness [94]. In this study, economising breath, assessment of inhalation, the
pitch and loudness will be omitted to reduce rater fatigue opening of the mouth and a final conclusion
and as it can be more reliably assessed using describing the assessed main issue to be addressed.
EGG/Acoustic measures. The voice samples to be
assessed will consist of the first paragraph of ‘Arthur the All voice samples will be rated by four experienced
rat’ and sustained vowels. Training and external anchors CVT-Ps in a similar manner to that to the SLT-V raters
will be provided to overcome the reduced intra-rater and using the same voice samples. The CVT-Ps will undergo a
inter-rater agreement associated with the increased training programme in the use of the CVT-STAR to
freedom of judgement [92]. improve inter-rater reliability [95, 96]. The mean rating of
All voice samples will be rated by four experienced the four judges for each recording will be used as the data
SLT-Vs who will undergo a brief refresher training point for individual patients. Aerodynamic measures: MPT
programme in the use of CAPE-V to improve inter-rater MPT is a simple and inexpensive aerodynamic voice
reliability [95, 96]. The raters will be blinded to the parameter for measuring glottal competence and is
whether the recording is pre- or post-therapy. Twenty expressed in seconds [93]. The patient is asked to inhale
percent of samples will be re-rated. Samples will be deeply and then sustain a steady /α/ vowel, as in farm, for
randomly ordered and coded. The severity of each as long as possible. The longest duration of the three
judgment will be quantified by an ‘X’ mark through a 100- consecutive attempts will be selected as the MPT measure
mm horizontal line, where the far left end of the line for analysis. MPT will be measured from the time axis of
represented normal (and thus assigned a rating of 0) and the acoustic signal on the speech studio recording. The
the far right end of the line represented most abnormal change from pre- to post-therapy value will be recorded
(and thus assigned a rating of 100) [94, 97, 98]. Listeners and analysed with each subject acting as their own control
will rate the perceptual dimensions of (a) overall severity, to account for individual variation and the recognition of
(b) roughness, (c) breathiness and (d) strain in a similar the significant difference between MPT values in men and
manner as that of Kapsner-Smith et al. [99]. The mean women [100]. MPT can be used with caution as a measure
rating of the four judges for each recording will be used as of laryngeal dysfunction when inadequate glottal airway
the data point for individual patients. resistance is suspected and provides an indicator of the

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 10 of 18
degree of ‘physiological support’ for speech [100]. a Number of eligible patients measured as a proportion
However, it does not distinguish between inefficient of the total number of patients presenting during the
glottal valving from reduced poor respiratory reserve and study period with primary MTD recorded in the
poor driving pressure of vocal fold vibration [100]. Values eligibility log
under 10 s are regarded as pathological. In a study of 8 b Number of patients recruited to the trial as a
patients with MTD using stretch-andflow voice therapy by proportion of those eligible, as recorded in the
Watts et al. [59], there was a mean improvement in MPT eligibility log
from 12.36 ± 3.61 to 15.49 ± 4.33 (p = 0.14) with a c Number of patients having at least one therapy
significant clinical effect (medium effect size of d = 0.79). session as a proportion of those recruited
It was postulated that the improvement was due to d Number of patients having at least one therapy
improved control and coordination of the respiratory and session as a proportion of those recruited and
laryngeal mechanisms associated with reduced consented e Number of patients completing the study
physiological effort. It is hypothesised that MPT values as a pro-
will increase post-CVT therapy. portion of those recruited, measured using the case
report form at the end of the study
Secondary aim 1: is it feasible to perform a pilot study using f The amount of clinical outcomes data completed
CVT-VT administered by a CVT-P using telehealth? measured using the case report form at each time
The integrity of the protocol and rationale will be assessed point (pre- and post-treatment)
under four main categories: process, resources, g Number of voice therapy sessions received by each
management and scientific [101]. The feasibility criteria, patient measured using clinical notes at the end of the
objectives, measures to be used and questions to be study and whether patients request additional SLT-VT
answered are outlined in (Table 3). at the end of the study

Secondary aim 2: is CVT-VT acceptable to patients, CVT-Ps

and SLT-VTs? Retrospective acceptability
Acceptability is a multifaceted construct that reflects the Retrospective assessment of will be limited to perceived
extent to which people delivering or receiving a healthcare effectiveness of treatment, including whether the goals of
intervention consider it to be appropriate, based on treatment were achieved, the satisfaction with the CVTVT
anticipated or experiential cognitive and emotional and use of telehealth. A non-validated patient
response to the intervention [102]. Patients will be questionnaire (see Additional file 5) will be used and the
assessed for this feasibility outcome prospectively, data obtained will be used to develop a more detailed
concurrently and retrospectively and success will be rated questionnaire for use in future studies. A similar
using a traffic light system [43, 44]. Prospective questionnaire will be administered to the treating CVT-P.
acceptability The results will be reported using summary statistics. If
The project design was discussed with experienced SLTVs further SLT-VT is requested by the patient qualitative data
both at (n = 3) and external to the study site (n = 3). The will be used to report what elements of the voice or vocal
CVT treatment protocols and assessment methods were function had not been addressed. Acceptability of CVTVT
reviewed and discussed with CVT teachers at the to the other important stakeholder, the SLT-Vs, will be
Complete Vocal Institute in Copenhagen (n = 10). Peer assessed using a Likert scale (1) indicating their
review was obtained by the Innovation Fund Denmark at satisfaction with the response to therapy as administered
the point of funding acceptance. The project was also by the CVT-P and (2) whether they would support the
discussed at an NUH Patient & Public Involvement (PPIE) concept of a randomised controlled study of CVT-VT
‘drop-in’ session in December 2021 and with 12 patients versus SLT-VT. The study results would be presented to
attending the Joint Voice clinic at NUH. All gave positive 10 SLTVs at a meeting attended by specialist SLT-Vs.
feedback and comments helped inform the final study
design and protocol (see Additional file 4). Secondary Aim 3: does CVT-VT offer a new approach to
improving the voice and vocal function compared to
traditional SLT-VT methods?
Concurrent acceptability A third feasibility outcome is to evaluate if, and how,
An important measure of acceptability of the study CVT-VT differs from traditional SLT-VT methods of
protocol to patients is recruitment and compliance with therapy. If CVT-VT offers a novel approach to
study protocol (see Table 3). Objective measures of management, it could be a useful additional tool for SLT-
behaviour, as indicators of acceptability, will be measured VTs
using:

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 11 of 18
Table 3 Summary of feasibility criteria
OBJECTIVE MEASURE QUESTIONS

PROCESS: FEASIBILITY OF THE PROCESSES THAT ARE KEY TO SUCCESS OF MAIN STUDY
Patients meeting eligibility criteria • Total number of patientsNumber of patients meeting eligibility criteriapresenting with primary MTD ×100% • What is potential pool of

patients with MTD? Concurrent acceptability: Patients meeting • Total number of patients meetingNumber of patients recruitedeligibility criteria ×100% • What is potential

recruitment rate?

eligibility criteria recruited • Qualitative data on reasons for non-recruitment

Concurrent acceptability: Recruitment rates • Number of patients having at least one therapy sessionNumber of patients having at least one therapy sessionTotal number of patients recruited
Total number of patients recruited&consented
eligibility and exclusion criteria?
• Number of patients recruited in 6 month
time period ×100%
• Qualitative data on reasons for non-
recruit-ment following consent •
• Qualitative data on reasons for non-
What
progres-sion to therapy following consent &
recruitment is
Concurrent acceptability: Total number of • Number of patients completing the study • How many patients completed the
patients completing the study Total number of study?
patients recruited ×100%

• Number of patients completing the study

potential recruitment to therapy rate?• Can recruitment be improved by modifying against target • ×100%
RESOURCES: ASSESSING TIME AND RESOURCE PROBLEMS THAT CAN OCCUR DURING MAIN STUDY
Determining process time • Qualitative data: administration of clinic • How many patients can be seen per hour?
appoint-ments including patients contact
• Qualitative data: Length of time to
complete research clinic tasks
Concurrent acceptability: Adherence to • Dropout rates % • Does CVT-P address recruited MTD patients
protocol • Qualitative data: on reasons for non- needs?
comple-tion of treatment
• Number of patients requesting further SLT therapy sessionTotal

number of patients recruited&consented ×100%

• Qualitative data: on reasons for requesting

further therapy
Patient costs • Travel costs (median + range) • What was the financial cost to the patient
travelling to the research clinic appointments?
Missing data • The amount of clinical outcomes data • How much missing data is recorded and what
completed measured using the case report form where the reasons for this?
at each time point (pre- and post-treatment)
• Qualitative data: on reasons for missing
data
MANAGEMENT: HUMAN & DATA MANAGEMENT PROBLEMS
Personnel/equipment/facility availability
• Qualitative data: Personnel/equipment/facility • Are there any issues with
availability for research visits personnel/equipment/ facility availability for
• Qualitative data: Equipment availability for research visits?
patient
• Qualitative data: issues with
booking/attendance of therapy sessions
Retrospective acceptability: Teleheath • Questionnaire using Likert scale (see Additional • Is the
use of telehealth satisfactory for patients file 5: Patient/CVT-P goals and feedback ques- and
the CVT-P?
tionnaire)
SCIENTIFIC: ASSESSMENT OF TREATMENT SAFETY, DOSE, RESPONSE, EFFECT, AND VARIANCE OF EFFECT
Study conduct • Qualitative data: issues with documentation and • Is the Case Report Form adequate?
data entry • Is the Database adequate?
Safety • Qualitative data of SLT-V observations of CVT-P • Is CVT-VT safe to use healthcare
intervention?
sessions
• Qualitative data: Feedback from any post-study
SLT-VT
• Reporting of adverse and serious adverse events
• Qualitative data from sponsor monitoring visits
Concurrent acceptability: Number of • Average number of recorded CVT-VT sessions • How many CVT-VT
CVTVT sessions sessions were required on per patient average?
• Qualitative data recording reasons for terminating • Was this adequate?
sessions
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 12 of 18
Retrospective acceptability: Patient satisfaction with therapy • Questionnaire using Likert scale: Descriptive
satisfied with therapy received?
statistics (see Additional file 5: Patient/CVT-P
goals and feedback questionnaire)
Table 3 (continued)
OBJECTIVE MEASURE QUESTIONS

Retrospective acceptability: • Questionnaire using Likert scale: Descriptive • Did the patient achieve their pre-therapy goals
Achievement of patients goals statistics (see Additional file 5: Patient/CVT-P following treatment?
goals and feedback questionnaire)
Retrospective acceptability: CVT-P • Questionnaire using Likert scale: Descriptive • Was the CVT-P satisfied with therapy received?
satisfaction with therapy statistics (see Additional file 5: Patient/CVT-P
goals and feedback questionnaire)
Retrospective acceptability: • Questionnaire using Likert scale: Descriptive • Did the CVT-P feel the pre-therapy goals agreed
Achievement of CVT-P goals statistics (see Additional file 5: Patient/CVT-P with the patient following treatment were met?
goals and feedback questionnaire)
Primary outcome measure: Voice and vocal • Self-rated questionnaire (VHI): Inferential • Was the primary outcome measure for therapy
function statistics: Difference in pre-post total scores , achieved?
effect size
Secondary outcome measures: Throat • Self-rated questionnaire (VTDS):Inferential • Do these secondary outcome measures
symptoms statistics - Difference in pre-/post total scores , improve following therapy?
effect size
Secondary outcome measures: Aerodynamic • MPT: Inferential statistics: Inferential statistics - • Do these secondary outcome measures
measure Difference in pre-/post total scores , effect size improve following therapy?
Secondary outcome measures: Objective • Acoustic/EGG measures: Inferential statistics - • Do these secondary outcome measures
voice measure & laryngeal vibratory pattern Difference in pre-/post total scores , effect size improve following therapy?
Secondary outcome measures: Perceptual • Auditory-perceptual ratings (CAPE-V): Inter and • Do these secondary outcome measures
voice analysis improve intra-rater rating pre/post rating scores following therapy?
in the management of MTD or provide a role for CVTP’s interventions i.e. how they should be explained, illustrated
in supporting SLT-Vs in the management of cohorts of and exemplified and how they benefit the patient and their
MTD patients. Firstly, a qualitative assessment of the contextual usefulness.
anonymised therapists’ sessional treatment records will be Those patients who agree for their therapy sessions to be
made using a preliminary organising framework and the recorded will have these recordings made and stored in
initial codes will be identified and based on the line with Trust-approved guidelines. The anonymised
‘ingredients’ and ‘targets’ of the therapy methods applied sessional recordings will then be transcribed and redacted
during the treatment sessions. These codes will be used to to exclude any personal or identifiable information. The
assess the content of transcripts of the CVT-VT sessions transcripts will be coded using the qualitative research
using a qualitative thematic deductive content analysis management software NVivo based on the principles of
approach. This will be based on the ‘ingredients’ and template analysis [104], a commonly used thematic
‘targets’ outlined in the CVT methodology (see CVT analytical framework allowing for a priori and crystalising
intervention above) and by using the Rehabilitation themes in qualitative analyses. The main aim is to identify
Treatment Specification System (RTSS) [103] applied to the differences and similarities of SLT-VT and CVT-VT
SLT-V management of voice disorders [20, 29, 39]. This approaches to therapy.
dual approach should allow easier direct comparison of
‘ingredients’ and ‘targets’ employed using both CVT and b) Observation of CVT therapy sessions by SLT-V
standard speech therapy terminology. This process will be
aided by direct SLT-V observations of sampled CVTVT All patients will be asked to give specific consent for
sessions. observation of their therapy sessions by the experienced
study SLT-V. However, not all those who give consent will
a) Transcriptions of therapy sessions be observed for practical reasons, but the aim is to observe
at least one patient through the 6 weeks of their therapy
Transcription of therapy sessions will be performed ad and sample a further six therapy sessions at different
verbum, with an explicit focus on the detailing the stages of their therapy. The observations will aid the SLT-
‘ingredients’ and ‘targets’ of the intervention techniques V in identifying which ‘ingredients’ and ‘targets’ are being
and exercises from both a CVT-VT and SLT-VT used and if they differ from traditional SLT-VT
perspective [20, 29, 39]. A further potential value of the techniques. Further observations regarding the delivery
transcriptions is to provide supportive analyses for the methods, the type of feedback, progression rules
documentation of the interventions and development of
good clinical guidelines for working with CVT

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 13 of 18
Table 4 Summary of progression criteria using traffic light system
Aim Green Amber Red

CVT-VT improves the VHI score > 20% improvement in VHI score 10–20% improvement in VHI score < 10% improvement in VHI score
A CVT-VT study is feasible to > 9 patients completed pre- and 8–9 patients completed pre- and < 8 patients completed pre- and
perform post-therapy outcome assessments post-therapy outcome assessments post-therapy outcome assessments
CVT-VT is acceptable to patients > 9 patients satisfied or very 8–9 patients satisfied or very < 8 patients satisfied or very
satisfied with therapy they have satisfied with therapy they have satisfied with therapy they have
received received received
CVT-VT is acceptable to CVT-Ps CVT-P satisfied or very satisfied with CVT-P satisfied or very satisfied with CVT-P satisfied or very satisfied with
therapy delivered in > 9 patients therapy delivered in 5–9 patients therapy delivered in < 5 patients
CVT-VT is acceptable to SLT-VTs (1) > 8 out of 10 SLT-VTs satisfied or > 5–8 out of 10 SLT-VTs satisfied or < 5 out of 10 SLT-VTs satisfied or
very satisfied with the outcome of very satisfied with the outcome of very satisfied with the outcome of
the study the study the study
CVT-VT is acceptable to SLT-VTs (2) > 8 out of 10 SLT-VTs would > 5–8 out of 10 SLT-VTs would < 5 out of 10 SLT-VTs would support
support the concept of an RCT of support progression to a RCT of CVT- progression to a RCT of CVT-VT vs
CVT-VT vs SLT-VT based on the VT vs SLT-VT based on the outcome SLT-VT based on the outcome of the
outcome of the study of the study study
Recruitment rate achieved > 9 patients recruited in 6 months 8–9 patients recruited in 6 months < 8 patients recruited in 6 months
and dosing of the ingredients will be made in line with the (‘very satisfied’ or ‘satisfied’) from the post-therapy
RTSS framework [20, 29]. An attempt will be made to questionnaire for at least 9 patients would be set as criteria
outline the hypothesised ‘mechanisms of action’ and how (Table 4). For SLT-VTs, two criteria would be tested as
both the ‘ingredients’ and ‘targets’ are linked to the patient ‘green’ criteria: (1) 8 or more out of 10 rating the outcome
‘Aims’. This will enable a critical comparison of the type of the study as ‘very satisfied’ or ‘satisfied’ and (2) 8 or
of techniques employed by the CVT-P to traditional SLT- more out of 10 rating that they would be happy to support
VT techniques. In addition, observation of CVTVT an RCT of CVT-VT versus SLT-VT.
sessions provides a level of governance to ensure the
patients goals are being met. Sample size Data handling, analysis plan and statistical methods
The justification for the sample size is based on the We will record and report the participant flow according to
objective of assessing feasibility [48]. In this study, the CONSORT guideline and produce a CONSORT flowchart
two main criteria are a change in the primary outcome [105]. As a feasibility study, we expect to analyse
measure, the VHI and recruitment. A previous recruitment and retention data using descriptive statistics
representative study of SLT-VT in MTD of ten patients in involving both intention-to-treat and actual completed
the active treatment group resulted in a 50% reduction in participant data. We shall report recruitment and retention
VHI score. Recruiting ten patients in 6 months would figures together with reasons for loss of participants. An
therefore provide a good indication of potential important part of this feasibility is also to assess whether
improvement in the primary outcome measure and the six weekly treatment sessions provide adequate input to
ability to recruit an adequate number of patients in a 6 achieve the patient goals set at the outset of therapy and if
month time frame. not we shall report what was not addressed.
The supervising team and Sponsor (Nottingham
Progression criteria University Hospitals Research and Development team)
Determining progression criteria is seen as an essential will monitor progress during treatment, consider any
element in assessing the success of a feasibility study [44]. adverse effects and use that information to continue or halt
Using a traffic light system provides a method of defining the trial. Patients will be offered payment for travel costs
targets for progression with green indicating ‘go’, amber for face-toface research clinic appointments or to attend
‘amend’ and red ‘stop’ [44]. Seven feasibility criteria have the outpatient clinic for video-linked therapy sessions if
been identified that provide key indicators that will inform personal equipment is not adequate, but not for
whether progression to a pilot randomised controlled participation in the study.
study of CVT-VT versus SLT-VT. Firstly it is essential in Quantitative standard descriptive and inferential
this underpowered study that CVT-VT can improve the statistics methods will be applied to compare pre-and
voice and vocal function i.e. VHI score. Although up to posttherapy measures (median + interquartile ranges with
50% change in VHI score is often seen in VHI scores for 95% CI). Statistical analyses of audio and EGG recorded
SLT-VT interventions [60], > 20% improvement seems data will be performed using Speech Studio
adequate for a green outcome. Recruitment of > 9 patients (Laryngograph) and the SPSS Statistics package (Vers.
who complete the study in 6 months would also indicate a 24.0.0.2 IBM Corporation, Chicago, IL).
satisfactory ‘green’ recruitment rate. From a patient and VHI, VTDS and MPT will be reported using descriptive
CVT-P perspective, a ‘green’ acceptability outcome of statistics (median + interquartile ranges with 95% CI) and

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 14 of 18
the P values (0.5) and effect sizes calculated for the previously applied to a patient population, and this paper
differences in pre- and post-treatment values using the outlines the protocol for a feasibility study. The four aims
Wilcoxon rank-sum test. Effect size together with the trial of this study have been described i.e. (1) to demonstrate
parameter data (i.e. recruitment, retention, follow-up and whether CVT-VT improves the voice and vocal function
completion rate) will be used to determine the size of in patients with MTD as measured using the primary
sample necessary to carry out a fully powered randomised outcome measure (VHI); (2) whether a CVT-VT study is
controlled trial comparing CVT-VT to SLTVT. For CAPE- feasible to perform; (3) whether CVT-VT is acceptable to
V both descriptive statistics, the inter- and intra-rater patients, CVT-Ps and SLT-VTs; and (4) whether CVT-VT
reliability scores using Cohen’s Kappa will be reported for offers a new approach to improving the voice and vocal
the individual parameters. For the acoustic and EGG function compared to traditional SLT-VT method. In
measures descriptive summary statistics and pre- and post- addition, it will provide preliminary evidence on
therapy paired-samples t tests will be performed again implementability of CVT-VT as a healthcare intervention
using Wilcoxon rank-sum tests. The relationships between by assessing the feasibility, acceptability and of this
the results of the VHI, VTDS and MPT will be estimated method as well as help develop criteria for future fidelity
by means of the Pearson r coefficient. Other non-validated assessment [106]. Seven progression criteria for a
questionnaires will be reported using descriptive statistics. randomised controlled pilot have been outlined using the
Recruitment and retention data will be analysed using traffic light system [44]. The protocol for this feasibility
descriptive statistics. study has been developed according to the principles of
good practice outlined by Lancaster et al. (2004) [50]. The
Ethics SPIRIT 2013 checklist [107] for protocol development has
Favourable ethical opinion for conduct has been granted been applied, and the study results will be reported against
by the East of England - Cambridge South Research the checklist adopted from the CONSORT statement [46,
Ethics Committee (Reference no. 22/EE/0047). 105].

Dissemination policies
Abbreviations
The aim of dissemination will be to inform other speech ANOVA Analysis of variance
and language therapists and CVT practitioners of the Ax A mplitude of acoustic signal (dB)
outcome of this approach of treating patients with MTD. CAPE-V C onsensus auditory-perceptual evaluation of voice
CI C onfidence interval
This will be achieved through scientific conference
CVI Complete vocal institute
presentations and workshops and feedback obtained to CRF Case-report form
inform SLT-VT acceptability. A paper will be written for a CVT Complete vocal technique
peer-reviewed publication, and the results will be CVT-P C omplete Vocal Technique practitioner
CVT-VT Complete Vocal Technique voice therapy
published using CONSORT extension guidelines for pilot
dB Decibel
and feasibility trials. DPIA Data Protection Impact Assessment
EGG E lectroglottography
Discussion ENT Ear, Nose and Throat
EAI Equal appearing interval
MTD is a common cause of voice problems but is a Fx Fundamental frequency measured from EGG signal
heterogeneous group of conditions causing varying (Hz)
degrees of functional limitation. The common feature for HNR Harmonics to noise
HRA Health Research Authority
type I– III MTD is an imbalance of the three main
HCRW Health and Care Research Wales
mechanisms for voice production mainly breath support, Hz Hertz
laryngeal muscle tension and neck and pharyngeal muscle LTAS Long-term average spectrum
tension (hyper-constriction) affecting resonance. MPT M aximum phonation time
MTD Muscle tension dysphonia
Traditional methods of treatment include a large range of MTP Muscle tension pattern
direct voice therapy methods, often used in combination. NNE N ormalised noise energy
Although widely employed successfully by SLT-Vs, many NUH N ottingham University Hospitals
PPIE Patient and public involvement
of the methods do not have a high level of evidence to RTSS Rehabilitation Treatment Specification System
support their use, and overlap in physiological aims. In QMC Q ueen’s Medical Centre
addition, reducing constriction and producing a normal Qx Contact quotient measured from EGG signal (%)
RFS Reflux Finding Score
sounding voice do not always equate to improved voice SD S tandard deviation
function in demanding physical environments or social SLT S peech and language therapy
situations. CVT-VT is a well-defined structured approach SLT-V Speech and language therapist specializing in voice
SLT-VT S peech and language therapy voice therapy
that enables singers and other professional voice VAS V isual analog
users/performers to produce their voice in a healthy VHA V ocal hygiene advice
manner for their vocal needs. CVT-VT has not been VHI Voice Handicap Index

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 15 of 18
VT V oice therapy Consent for publication
VTDS V ocal Tract Discomfort Scale Consent for use of anonymised data for publication or in presentations using
an Ethical Committee approved form will be taken at the same time as
consent to take part in the study.
Supplementary Information
The online version contains supplementary material available at https:// doi. Competing interests
org/ 10. 1186/ s40814- 023- 01317-y. Cathrine Sadolin is the founder of the Complete Vocal Technique and
Director of the Complete Vocal Institute. Mathias Aaen is an employee of the
Additional file 1. Looking after your larynx advice leaflet. Complete Vocal Institute.
Julian McGlashan and Anna White have no competing interests.
Additional file 2. Outline of therapy sessions.
Additional file 3. CVT Speech Therapy Assessment Rating_CVT-STAR. Author details
1
Ear, Nose and Throat Department, Queen’s Medical Centre Campus,
Additional file 4. Summary of patient survey.
Nottingham University Hospitals, Nottingham NG7 2UH, UK. 2 Complete Vocal
Additional file 5. Patient/CVT-P goals and feedback questionnaire. Institute, Kompagnistraede 32A, 1208 Copenhagen K, Denmark. 3 Honorary
Researcher, Ear, Nose and Throat Department, Queen’s Medical Centre
Campus, Nottingham University Hospitals, Nottingham NG7 2UH, UK.
Acknowledgements
We thank all the patients in the Patient Participant Group, Katherine Received: 3 July 2022 Accepted: 2 May 2023
Behenna,
Cathy Gass and Suzanne Slade, Highly Specialised Speech and Language
Therapists at NUH and Professor Paul Carding Director of the Oxford Institute
of Nursing, Midwifery and Allied Health Research (OxINMAHR), at Oxford
Brookes University for their input and feedback on the study design. References
1. Lyberg-Åhlander V, Rydell R, Fredlund P, Magnusson C, Wilén S.
Authors’ contributions
Prevalence of voice disorders in the general population, based on the
JM, MA and CS conceived the study and initiated the design with input from Stockholm Public Health Cohort. J Voice. 2019;33(6):900–5.
AW. JM wrote the protocol and produced the documents and submitted all
2. Roy N, Fetrow RA, Merrill RM, Dromey C. Exploring the clinical utility of
necessary documentation to regulating authorities. JM and MA devised
relative fundamental frequency as an objective measure of vocal
outcome measures. MA and CS developed the CVT therapy guide and CVT
hyperfunction. J Speech Lang Hear Res. 2016;59(5):1002–17.
speech assessment form. MA, JM and AW advised on both the qualitative
3. McGlashan JA, Costello D, Bradley PJ. Hoarseness and voice problems.
element and statistical measures for evaluation of objective outcome
In: Ludman H, Bradley PJ, editors. ABC of Ear, Nose and Throat. 5th ed.
measures for the study. JM, MA and AW wrote the paper with input and
Oxford: Blackwell Publishing; 2007. p. 71–7.
approval of the final manuscript from CS. The authors read and approved the
4. Altman KW, Atkinson C, Lazarus C. Current and emerging concepts in
final manuscript.
muscle tension dysphonia: a 30-month review. [Review] [55 refs]. J
Voice. 2005;19(2):261–7.
Funding
5. Roy N, Dietrich M, Blomgren M, Heller A, Houtz DR, Lee J. Exploring
This work was supported by the Innovation Fund Denmark Innovation Fund
the neural bases of primary muscle tension dysphonia: a case study
Denmark (www. innov ation sfond en. dk) through The Industrial Researcher
using functional magnetic resonance imaging. J Voice. 2019;33(2):183–
Programme (Case number: 8054-00039B) 26A Østergade, 4th floor 1100
94.
Copenhagen K, Denmark, contact: Tel. + 45 6190 5002
6. Desjardins M, Apfelbach C, Rubino M, Verdolini AK. Integrative review
[email protected]. The study sponsor and funder have no role in
and framework of suggested mechanisms in primary muscle tension
the study design, the collection of data, the management of data, the
dysphonia. J Speech Lang Hear Res. 2022;65(5):1867–93.
analysis thereof or its interpretation. The grant holder and team members
7. Spencer ML. Muscle tension dysphonia: a rationale for symptomatic
employed under the grant are solely responsible for writing the report and
subtypes, expedited treatment, and increased therapy compliance.
the decision to submit the report for publication. The study sponsor is
Perspect Voice Voice Disord. 2015;25(1):5–15.
Nottingham University Hospitals NHS Trust. The contact for the sponsor is
8. Titze IR. Acoustic interpretation of resonant voice. J Voice.
Mrs. J. Boston ([email protected]) and Mr. M. Sanderson is the
Senior Research Governance Facilitator at NUH. Dr. L. Gelling is the Chair of 2001;15(4):519–28.
the East of England—Cambridge South Research Ethics Committee 9. Van Houtte E, Van Lierde K, Claeys S. Pathophysiology and treatment of
([email protected]). The study sponsor and funder have no muscle tension dysphonia: a review of the current knowledge. J Voice.
role in the study design, the collection of data, the management of data and 2011;25(2):202–7.
the analysis thereof or its interpretation. The grant holder and team 10. Kunduk M, Fink DS, McWhorter AJ. Primary muscle tension dysphonia.
members employed under the grant are solely responsible for writing the Curr Otorhinolaryngol Rep. 2016;4(3):175–82.
report and the decision to submit the report for publication. 11. Sama A, Carding PN, Price S, Kelly P, Wilson JA. The clinical features of
Availability of data and materials functional dysphonia. Laryngoscope. 2001;111(3):458–63.
Further details can be accessed at Muscle Tension Dysphonia Trial in 12. Mayerhoff RM, Guzman M, Jackson-Menaldi C, Munoz D, Dowdall J,
Nottingham (Complete Vocal Technique Voice Therapy) | Clincosm. The Maki A, et al. Analysis of supraglottic activity during vocalization in
final anonymised trial dataset as a result of this study will be available healthy singers. Laryngoscope. 2014;124(2):504–9.
to other researchers on request from the corresponding author. 13. Belisle GM, Morrison MD. Anatomic correlation for muscle tension
dysphonia. J Otolaryngol. 1983;12(5):319–21.
14. Koufman JA, Blalock PD. Functional voice disorders. Otolaryngol Clin
Declarations North Am. 1991;24:1059–73.
15. Harris S. Speech therapy for dysphonia. In: Harris T, Howard DM,
Ethics approval and consent to participate editors.
This study has been approved by the NHS Health Research Authority (HRA) The Voice Clinic Handbook. 2nd ed. Oxford: Compton Publishing;
and Health and Care Research Wales (HCRW) (14 April 2022) following 2018. p. 83–158.
favourable Ethical opinion for conduct by the East of England—Cambridge 16. Rammage LA, Morrison M, Nichol H, Pullan B, Salkeld L, May P. Causes
South Research Ethics Committee (Reference no. 22/EE/0047). Any changes and classifications of voice disorders. The management of voice
to the protocol will be submitted to the NHS HRA and HRCW as well as the disorders. 2nd ed. San Diego: Singular; 2001. p. 67–103.
Cambridge South Research Ethics Committee. A full Data Protection Impact 17. Hsiung MW, Hsiao YC. The characteristic features of muscle tension
Assessment (DPIA) submission and Capacity and Capability assessment were dysphonia before and after surgery in benign lesions of the vocal fold.
made with approvals. The trial has been registered on a publicly accessible ORL J Otorhinolaryngol Relat Spec. 2004;66(5):246–54.
database (ClinicalTrials.gov: NCT05365126).

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 16 of 18
18. Koufman J. Evaluation of laryngeal biomechanics by transnasal flexible 41. Rangarathnam B, McCullough GH, Pickett H, Zraick RI, Tulunay-Ugur O,
laryngoscopy. In: Rubin JSS, Sataloff RT, Korovin GS, editors. Diagnosis McCullough KC. Telepractice versus in-person delivery of voice therapy
and treatment of voice disorders. 4th ed. San Diego: Plural Publishing for primary muscle tension dysphonia. Am J Speech Lang Pathol.
Inc; 2014. p. 223–33. 2015;24(3):386–99.
19. Roy N, Bless DM, Heisey D. Personality and voice disorders: a 42. Aaen M, Sadolin C, White A, Nouraei R, McGlashan J. Extreme vocals-a
multitraitmultidisorder analysis. J Voice. 2000;14(4):521–48. retrospective longitudinal study of vocal health in 20 professional
20. Van Stan JH, Roy N, Awan S, Stemple J, Hillman RE. A taxonomy of singers performing and teaching rough vocal effects. J Voice.
voice therapy. Am J Speech Lang Pathol. 2015;24(2):101–25. 2022:S08921997(22)00134-5. https:// doi. org/ 10. 1016/j. jvoice.
21. Taylor-Goh S. RCSLT Clinical Guidelines. Oxon: Routledge; 2017. 2022. 05. 002.
22. Schwartz SR, Cohen SM, Dailey SH, Rosenfeld RM, Deutsch ES, Gillespie 43. Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA.
MB, et al. Clinical practice guideline: hoarseness (dysphonia). Determining sample size for progression criteria for pragmatic pilot
Otolaryngol Head Neck Surg. 2009;141(3 Suppl 2):S1-s31. RCTs: the hypothesis test strikes back! Pilot Feasibility Stud.
23. Roy N, Gray SD, Simon M, Dove H, Corbin-Lewis K, Stemple JC. An 2021;7(1):40.
evaluation of the effects of two treatment approaches for teachers 44. Avery KN, Williamson PR, Gamble C, O’Connell Francischetto E,
with voice disorders: a prospective randomized clinical trial. J Speech Metcalfe C, Davidson P, et al. Informing efficient randomised controlled
Lang Hear Res. 2001;44(2):286–96. trials: exploration of challenges in developing progression criteria for
24. Colton RH, Casper JK, Leonard R. Differential diagnosis of voice internal pilot studies. BMJ Open. 2017;7(2):e013537.
problems Understanding Voice Problems. 4th ed. Philadelphia: 45. Bond C, Lancaster GA, Campbell M, Chan C, Eddy S, Hopewell S, et al.
Lippincott Williams & Wilkins; 2011. p. 11–62. Pilot and feasibility studies: extending the conceptual framework. Pilot
25. Stemple JC. A holistic approach to voice therapy. Semin Speech Lang. Feasibility Stud. 2023;9(1):24.
2005;26(2):131–7. 46. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L,
26. Guenther FH, Ghosh SS, Tourville JA. Neural modeling and imaging of et al. CONSORT 2010 statement: extension to randomised pilot and
the cortical interactions underlying syllable production. Brain Lang. feasibility trials. BMJ. 2016;355:i5239.
2006;96(3):280–301. 47. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić
27. Stemple JC, Roy N, Klaben BK. Clinical voice pathology: theory and K, et al. SPIRIT 2013 statement: defining standard protocol items for
management. 6th ed. San Diego: Plural Publishing, Inc.; 2020. clinical trials. Ann Intern Med. 2013;158(3):200–7.
28. Eastwood C, Madill C, McCabe P. The behavioural treatment of muscle 48. Thabane L, Lancaster G. A guide to the reporting of protocols of pilot
tension voice disorders: a systematic review. Int J Speech Lang Pathol. and feasibility trials. Pilot Feasib Stud. 2019;5:37.
2015;17(3):287–303. 49. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al.
29. Van Stan JH, Whyte J, Duffy JR, Barkmeier-Kraemer J, Doyle P, Gherson Better reporting of interventions: template for intervention description
S, et al. Voice therapy according to the rehabilitation treatment and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.
specification system: expert consensus ingredients and targets. Am J https:// doi. org/ 10. 1136/ bmj. g1687.
Speech Lang Pathol. 2021;30(5):2169–201. 50. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot
30. Dejong G, Horn SD, Gassaway JA, Slavin MD, Dijkers MP. Toward a studies: recommendations for good practice. J Eval Clin Pract.
taxonomy of rehabilitation interventions: using an inductive approach 2004;10(2):307–12.
to examine the “black box” of rehabilitation. Arch Phys Med Rehabil. 51. Jacobson BH, Johnson A, Grywalski C, Silbergleit A, Benninger MS. The
2004;85:678–86. Voice Handicap Index (VHI): development and validation. Am J Speech
31. Hart T, Tsaousides T, Zanca JM, Whyte J, Packel A, Ferraro M, et al. Lang Pathol. 1997;6:66–70.
Toward a theory-driven classification of rehabilitation treatments. Arch 52. Wilson JA, Webb A, Carding PN, Steen IN, MacKenzie K, Deary IJ. The
Phys Med Rehabil. 2014;95(1 Suppl):S33-44.e2. Voice Symptom Scale (VoiSS) and the Vocal Handicap Index (VHI): a
32. Van Stan JH, Ortiz AJ, Cortes JP, Marks KL, Toles LE, Mehta DD, et al. comparison of structure and content. Clin Otolaryngol. 2004;29:169–
Differences in daily voice use measures between female patients with 74.
nonphonotraumatic vocal hyperfunction and matched controls. J 53. Mathieson L, Hirani SP, Epstein R, Baken RJ, Wood G, Rubin JS.
Speech Lang Hear Res. 2021:64(5):1457–70. Laryngeal manual therapy: a preliminary study to examine its
33. Turkstra LS, Norman R, Whyte J, Dijkers MP, Hart T. Knowing what treatment effects in the management of muscle tension dysphonia. J
we’re doing: why specification of treatment methods is critical for Voice. 2009;23(3):353–66.
evidencebased practice in speech-language pathology. Am J Speech 54. Francis DO, Daniero JJ, Hovis KL, Sathe N, Jacobson B, Penson DF, et al.
Lang Pathol. 2016;25(2):164–71. Voice-related patient-reported outcome measures: a systematic review
34. Sadolin C. Complete vocal technique. Copenhagen: Shout Publishing; of instrument development and validation. J Speech Lang Hear Res.
2021. 2017;60(1):62–88.
35. McGlashan J, Thuesen MA, Sadolin C. Overdrive and edge as refiners of 55. Franic DM, Bramlett RE, Bothe AC. Psychometric evaluation of disease
“belting”?: an empirical study qualifying and categorizing “belting” specific quality of life instruments in voice disorders. J Voice.
based on audio perception, laryngostroboscopic imaging, acoustics, 2005;19(2):300–15.
LTAS, and EGG. J Voice. 2017;31(3):385.e11-.e22. 56. Behlau M, Zambon F, Moreti F, Oliveira G, de Barros Couto E, Jr. Voice
36. Thuesen MA, McGlashan J, Sadolin C. Curbing-the metallic mode self-assessment protocols: different trends among organic and
inbetween: an empirical study qualifying and categorizing restrained behavioral dysphonias. J Voice. 2017;31(1):112.e13-.e27.
sounds known as Curbing based on audio perception, 57. Roy N. Functional dysphonia. Curr Opin Otolaryngol Head Neck Surg.
laryngostroboscopic imaging, acoustics, LTAS, and EGG. J Voice. 2003;11(3):144–8.
2017;31(5):644.e1-.e10. 58. Kapsner-Smith MR, Hunter EJ, Kirkham K, Cox K, Titze IR. A randomized
37. Aaen M, McGlashan J, Christop N, Sadolin C. Deconstructing timbre controlled trial of two semi-occluded vocal tract voice therapy
into 5 physiological parameters: vocal mode, amount of metal, degree protocols. J Speech Lang Hear Res. 2015;58(3):535–49.
of density, size of larynx, and sound coloring. J Voice. 59. Watts CR, Diviney SS, Hamilton A, Toles L, Childs L, Mau T. The effect of
2021;S08921997(21)00386-6. https:// doi. org/ 10. 1016/j. jvoice. stretch-and-flow voice therapy on measures of vocal function and
2021. 11. 013. Online ahead of print. handicap. J Voice. 2015;29(2):191–9.
38. Leppavuori M, Lammentausta E, Peuna A, Bode MK, Jokelainen J, Ojala 60. Watts CR, Hamilton A, Toles L, Childs L, Mau T. A randomized
J, et al. Characterizing vocal tract dimensions in the vocal modes using controlled trial of stretch-and-flow voice therapy for muscle tension
magnetic resonance imaging. J Voice. 2021;35(5):804 e27-e42. dysphonia. Laryngoscope. 2015;125(6):1420–5.
39. Van Stan JH, Whyte J, Duffy JR, Barkmeier-Kraemer JM, Doyle PB, 61. Rodrigues G, Zambon F, Mathieson L, Behlau M. Vocal tract discomfort
Gherson S, et al. Rehabilitation treatment specification system: in teachers: its relationship to self-reported voice disorders. J Voice.
methodology to identify and describe unique targets and ingredients. 2013;27(4):473–80.
Arch Phys Med Rehabil. 2021;102(3):521–31. 62. Lopes LW, de Oliveira FV, Silva POC, da Nóbrega EUAC, Almeida
40. World Health Organization. Global diffusion of eHealth: making
universal health coverage achievable 2019 [Available from: https://
www. who. int/ publi catio ns/i/ item/ 97892 41511 780/.

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 17 of 18
AA. Vocal Tract Discomfort Scale (VTDS) and Voice Symptom Scale 87. Groll MD, McKenna VS, Hablani S, Stepp CE. Formant-estimated vocal
(VoiSS) in the evaluation of patients with voice disorders. J Voice. tract length and extrinsic laryngeal muscle activation during
2019;33(3):381.e23. modulation of vocal effort in healthy speakers. J Speech Lang Hear Res.
63. Guzman M, Acuña G, Pacheco F, Peralta F, Romero C, Vergara C, et al. 2020;63(5):1395–403.
The impact of double source of vibration semioccluded voice exercises 88. Lammert AC, Narayanan SS. On short-time estimation of vocal tract
on objective and subjective outcomes in subjects with voice length from formant frequencies. PLoS ONE. 2015;10(7):e0132193.
complaints. J Voice. 2018;32(6):770.e1-.e9. 89. Wakita H, editor Normalization of vowels by vocal-tract length and its
64. Niebudek-Bogusz E, Woźnicka E, Wiktorowicz J, Śliwińska-Kowalska M. application to vowel identification. IEEE Transactions on Acoustics,
Applicability of the Polish Vocal Tract Discomfort (VTD) scale in the Speech, and Signal Processing; 1977.
diagnostics of occupational dysphonia. Logoped Phoniatr Vocol. 90. Oates J. Auditory-perceptual evaluation of disordered voice quality:
2012;37(4):151–7. pros, cons and future directions. Folia Phoniatr Logop. 2009;61(1):49–
65. Torabi H, Khoddami SM, Ansari NN, Dabirmoghaddam P. The vocal 56.
tract discomfort scale: validity and reliability of the persian version in 91. Nagle K. Emerging scientist: challenges to CAPE-V as a standard.
the assessment of patients with muscle tension dysphonia. J Voice. Perspect ASHA Special Interest Groups. 2016;1:47.
2016;30(6):711–6. 92. Kreiman J, Gerratt BR. Perceptual assessment of voice quality: past,
66. Boersma P, Weenink D. Praat: doing phonetics by computer (Version present, and future. Perspect Voice Voice Disord. 2010;20:62–7.
6.1.40) [Computer program] Retrieved from: http:// www. praat. org/ 93. Hirano M. Clinical examination of voice. 1st ed. Vienna: Springer-
2018 [Available from: https:// www. fon. hum. uva. nl/ praat/. Verlag; 1981. p. 1981.
67. McGlashan J. Evaluation of voice. In: Watkinson JC, Clarke RW, editors. 94. Kempster GB, Gerratt BR, Verdolini Abbott K, Barkmeier-Kraemer J,
Scott Brown’s Otorhinolaryngology Head and Neck Surgery. 3. 8 ed: Hillman RE. Consensus auditory-perceptual evaluation of voice:
CRC Press 2018. development of a standardized clinical protocol. Am J Speech Lang
68. Hillenbrand J, Houde RA. Acoustic correlates of breathy vocal quality: Pathol. 2009;18(2):124–32.
dysphonic voices and continuous speech. J Speech Hear Res. 95. Walden PR, Khayumov J. The use of auditory-perceptual training as a
1996;39(2):311–21. research method: a summary review. J Voice. 2022;36(3):322–34.
69. Heman-Ackah YD, Heuer RJ, Michael DD, Ostrowski R, Horman M, 96. Walstrom A, Brehm SB, LeBorgne WD, Acord A, Gottliebson RO. Use of
Baroody MM, et al. Cepstral peak prominence: a more reliable terminology and the effect of training on auditory-perceptual ratings
measure of dysphonia. Ann Otol Rhinol Laryngol. 2003;112(4):324–33. of speaking voice by singing teachers. J Voice. 2021:S0892-
70. Watts CR, Awan SN, Maryn Y. A comparison of cepstral peak 1997(21)00337-
prominence measures from two acoustic analysis programs. J Voice. 4. https:// doi. org/ 10. 1016/j. jvoice. 2021. 09. 036.
2017;31(3):387.e1-.e10. 97. Zraick RI, Kempster GB, Connor NP, Thibeault S, Klaben BK, Bursac Z, et
71. Mahalingam S, Boominathan P, Arunachalam R, Venkatesh L, Srinivas al. Establishing validity of the consensus auditory-perceptual
S. Cepstral measures to analyze vocal fatigue in individuals with evaluation of voice (CAPE-V). Am J Speech Lang Pathol. 2011;20(1):14–
hyperfunctional voice disorder. J Voice. 2021;35(6):815–21. 22.
72. Klatt DH, Klatt LC. Analysis synthesis and perception of voice quality 98. Kempster G. CAPE-V: development and future direction. Perspect
variations among female and male talkers. J Acoust Soc Am. Voice Voice Disord. 2007;17(2):11–3.
1990;87:820–57. 99. Kapsner-Smith MR, Opuszynski A, Stepp CE, Eadie TL. The effect of
73. Kreiman J, Gerratt BR, Garellek M, Samlan R, Zhang Z. Toward a unified visual sort and rate versus visual analog scales on the reliability of
theory of voice production and perception. Loquens. 2014;1(1):e009. judgments of dysphonia. J Speech Lang Hear Res. 2021;64(5):1571–80.
https:// doi. org/ 10. 3989/ loquen s.2014. 009 . 100. Baken RJ, Orlikoff RF. Airflow and volume. Clinical measurements of
74. Van Stan JH, Mehta DD, Ortiz AJ, Burns JA, Toles LE, Marks KL, et al. speech and voice. 2nd ed. San Diego: Singular Thomson Learning;
Differences in weeklong ambulatory vocal behavior between female 2000. p. 337–91.
patients with phonotraumatic lesions and matched controls. J Speech 101. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on
Lang Hear Res. 2020;63(2):372–84. pilot studies: the what, why and how. BMC Med Res Methodol.
75. Kreiman J, Gerratt BR, Antoñanzas-Barroso N. Measures of the glottal 2010;10:1.
source spectrum. J Speech Lang Hear Res. 2007;50(3):595–610. 102. Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare
76. Kreiman J, Gerratt BR, Ito M. When and why listeners disagree in voice interventions: an overview of reviews and development of a
quality assessment tasks. J Acoust Soc Am. 2007;122(4):2354–64. theoretical framework. BMC Health Serv Res. 2017;17(1):88.
77. Tjaden K, Sussman JE, Liu G, Wilding G. Long-term average spectral 103. Hart T, Dijkers MP, Whyte J, Turkstra LS, Zanca JM, Packel A, et al. A
(LTAS) measures of dysarthria and their relationship to perceived theory-driven system for the specification of rehabilitation treatments.
severity. J Med Speech Lang Pathol. 2010;18(4):125–32. Arch Phys Med Rehabil. 2019;100(1):172–80.
78. Dromey C. Spectral measures and perceptual ratings of hypokinetic 104. King N. Doing template analysis. In: Symon G, Cassell C, editors.
dysarthria. J Med Speech-Lang Pathol. 2003;11(2):85–94. Qualitative Organizational Research: Core Methods and Current
79. Tanner K, Roy N, Ash A, Buder EH. Spectral moments of the long-term Challenges.
average spectrum: sensitive indices of voice change after therapy? J London: SAGE Publications, Inc.; 2012. p. 426–50.
Voice. 2005;19(2):211–22. 105. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised
80. Ma E, Robertson J, Radford C, Vagne S, El-Halabi R, Yiu E. Reliability of recommendations for improving the quality of reports of parallel-
speaking and maximum voice range measures in screening for group randomised trials. Lancet. 2001;357(9263):1191–4.
dysphonia. J Voice. 2007;21(4):397–406. 106. Klaic M, Kapp S, Hudson P, Chapman W, Denehy L, Story D, et al.
81. Lowell SY, Kelley RT, Colton RH, Smith PB, Portnoy JE. Position of the Implementability of healthcare interventions: an overview of reviews
hyoid and larynx in people with muscle tension dysphonia. and development of a conceptual framework. Implement Sci.
Laryngoscope. 2012;122(2):370–7. 2022;17(1):10.
82. Roy N, Ferguson NA. Formant frequency changes following manual 107. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krle AJK, et
circumlaryngeal therapy for functional dysphonia: evidence of al. SPIRIT 2013 Statement: defining standard protocol items for clinical
laryngeal lowering? J Med Speech-Lang Pathol. 2001;9(3):169–75. trials. Rev Panam Salud Publica. 2015;38(6):506–14.
83. Aronson AE, Bless DM. Clinical voice disorders. 4th ed. New York:
Thieme Medical Publishers Inc; 2009. p. 2009. Ready to submit your research ? Choose BMC and benefit from:
84. Hixon TJ, Weisemer G, Hoit JD. Preclinical speech science: anatomy, Publisher’s
physiology, acoustics, and perception. 3rd ed. San Diego: Plural • fast, convenient online submission
Publishing Inc.; 2020.
Note
Springer Nature • thorough peer review by experienced researchers in your field
85. Shipp T. Vertical laryngeal position: research findings and their
remains neutral • rapid publication on acceptance
relationship to singing. J Voice. 1987;1:217–9.
86. Stevens K. Acoustic phonetics. Revised ed. Cambridge: MIT Press Ltd; • support for research data, including large and complex data types
2000.
• gold Open Access which fosters wider collaboration and increased citations

• maximum visibility for your research: over 100M website views per year

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

At BMC, research is always in progress.
Learn more biomedcentral.com/submissions
McGlashan et al. Pilot and Feasibility Studies (2023) 9:88 Page 18 of 18
with regard to jurisdictional claims in published maps and institutional
affiliations.

Content courtesy of Springer Nature, terms of use apply. Rights reserved.

Terms and Conditions

Springer Nature journal content, brought to you courtesy of Springer Nature Customer Service Center GmbH (“Springer Nature”).
Springer Nature supports a reasonable amount of sharing of research papers by authors, subscribers and authorised users (“Users”), for
smallscale personal, non-commercial use provided that all copyright, trade and service marks and other proprietary notices are maintained. By
accessing, sharing, receiving or otherwise using the Springer Nature journal content you agree to these terms of use (“Terms”). For these
purposes, Springer Nature considers academic use (by researchers and students) to be non-commercial.
These Terms are supplementary and will apply in addition to any applicable website terms and conditions, a relevant site licence or a personal
subscription. These Terms will prevail over any conflict or ambiguity with regards to the relevant terms, a site licence or a personal subscription
(to the extent of the conflict or ambiguity only). For Creative Commons-licensed articles, the terms of the Creative Commons license used will
apply.
We collect and use personal data to provide access to the Springer Nature journal content. We may also use these personal data internally within
ResearchGate and Springer Nature and as agreed share it, in an anonymised way, for purposes of tracking, analysis and reporting. We will not
otherwise disclose your personal data outside the ResearchGate or the Springer Nature group of companies unless we have your permission as
detailed in the Privacy Policy.
While Users may use the Springer Nature journal content for small scale, personal non-commercial use, it is important to note that Users may
not:

1. use such content for the purpose of providing other users with access on a regular or large scale basis or as a means to circumvent access
control;
2. use such content where to do so would be considered a criminal or statutory offence in any jurisdiction, or gives rise to civil liability, or is
otherwise unlawful;
3. falsely or misleadingly imply or suggest endorsement, approval , sponsorship, or association unless explicitly agreed to by Springer Nature in
writing;
4. use bots or other automated methods to access the content or redirect messages
5. override any security feature or exclusionary protocol; or
6. share the content in order to create substitute for Springer Nature products or services or a systematic database of Springer Nature journal
content.
In line with the restriction against commercial use, Springer Nature does not permit the creation of a product or service that creates revenue,
royalties, rent or income from our content or its inclusion as part of a paid for service or for other commercial gain. Springer Nature journal
content cannot be used for inter-library loans and librarians may not upload Springer Nature journal content on a large scale into their, or any
other, institutional repository.
These terms of use are reviewed regularly and may be amended at any time. Springer Nature is not obligated to publish any information or
content on this website and may remove it or features or functionality at our sole discretion, at any time with or without notice. Springer Nature
may revoke this licence to you at any time and remove access to any copies of the Springer Nature journal content which have been saved.
To the fullest extent permitted by law, Springer Nature makes no warranties, representations or guarantees to Users, either express or implied
with respect to the Springer nature journal content and all parties disclaim and waive any implied warranties or warranties imposed by law,
including merchantability or fitness for any particular purpose.
Please note that these rights do not automatically extend to content, data or other material published by Springer Nature that may be licensed
from third parties.
If you would like to use or distribute our Springer Nature journal content to a wider audience or on a regular basis or in any other manner not

expressly permitted by these Terms, please contact Springer Nature at [email protected]