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Voice DisordersNCT06524193

RCT Face-to-face Group Voice Therapy vs Telepractice Group Voice Therapy for Muscle Tension Dysphonia

A study testing Telepractice group voice therapy and Face-to-face group voice therapy in people with Voice Disorders and Muscle Tension Dysphonia, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to compare face-to-face group voice therapy to telepractice group voice therapy for muscle tension dysphonia (MTD). The main questions it aims to answer are: The effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Voice Disorders, Muscle Tension Dysphonia, Aphonia
What is being tested?
Telepractice group voice therapy and Face-to-face group voice therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteHong Kong
Study dates
25 Jun 2024to Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Above or equal to 18 years of age;
  • Diagnosis of primary MTD or secondary MTD where voice therapy is the primary mode of treatment, such as vocal fold nodules;
  • Chinese-speaking subjects only.

Who cannot join

  • Dysphonia of neurogenic or psychogenic origin;
  • Secondary muscle tension dysphonia in which voice therapy is not the primary treatment modality, such as vocal polyp, vocal cyst, granuloma, papilloma;
  • Low computer literacy or without social or family support for telepractice;
  • Patients who are not capable of making own consent;
  • Patients who are receiving other modalities of treatment which is not part of this current study, such as traditional Chinese medicine.

Trial locations and contacts

1 site in 1 country.

Thomas Law, PhD contact

(852) 39439601

thomaslaw@cuhk.edu.hk

Yifeng Wei, Master contact

(852) 39439611

yifengwei@cuhk.edu.hk

Hong Kong1 site, 1 recruiting

  • Division of Speech Therapy, Dept of Otorhinolaryngology , Head and Neck Surgery, The Chinese University of Hong Kong

    Hong Kong

    Thomas Law, PhD, +852 39439601, thomaslaw@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Comparing Face-to-face Group Voice Therapy to Telepractice Group Voice Therapy for Muscle Tension Dysphonia: A Non-inferiority Randomized Controlled Trial

The goal of this clinical trial is to compare face-to-face group voice therapy to telepractice group voice therapy for muscle tension dysphonia (MTD). The main questions it aims to answer are:

  • The effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design.
  • The effectiveness of telepractice group voice therapy using a randomized controlled trial study design.

Participants will receive telepractice group voice therapy or face-to-face group voice therapy. Researchers will compare telepractice group voice therapy to face-to-face group voice therapy for patients with MTD to see if it has the same effectiveness.

Read the detailed description

STUDY OBJECTIVES

  1. Primary Objectives
  2. To evaluate the effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design.
  3. To evaluate the effectiveness of telepractice group voice therapy using a randomized controlled trial study design.
  4. Secondary Objectives
  5. To compare therapy dropout rate and treatment schedule adherence rate of the two modes of group voice therapy (comparing telepractice to face-to-face mode).
  6. To conduct cost-analysis to compare the health-service cost and patient-related cost of the telepractice and face-to-face group voice therapy.
  7. To further investigate the role of group climate in contributing to treatment outcome in group voice therapy.

BACKGROUND

  1. Muscle tension dysphonia
  2. Types and prevalence Muscle tension dysphonia (MTD) is a type of voice disorder that is characterized by excessive paralaryngeal musculature tension during phonation. There are two types of MTD, primary and secondary. Primary MTD is associated with the absence of organic vocal fold pathology, whereas secondary MTD is associated with the presence of organic vocal fold pathology. MTD is a prevalent voice disorder which constitutes up to 40% of the total voice disorder caseload. In Hong Kong, a study by our team also showed that MTD was highly prevalent in every four primary school teachers, one would have some degree of MTD.
  3. Cause, risk factors and impact The cause of MTD is multifactorial, including incorrect voicing techniques, phonotraumatic behaviours (such as yelling, screaming, and prolonged voice use), psychological and personality factors, compensation of an underlying disease (such as organic vocal fold pathology, reflux disorder, respiratory tract infection). Risk factors for MTD include female sex, lower education level and people in vocations with high vocal demands. MTD not only disrupts a person's voice quality but also their efficiency to produce voice for communication leading to impaired psychological wellbeing, reduced job performance, and economic loss due to workplace absenteeism.
  4. Voice therapy is the treatment for MTD The current gold standard treatment for primary MTD is behavioural voice therapy delivered by speech-language pathologists. For secondary MTD, behavioural voice therapy is recommended for those with vocal fold nodules. However, for other benign vocal fold pathologies, such as vocal polyps, cysts and granuloma, may require phonosurgery as their primary treatment modality.
  5. Disadvantages of the traditional individual voice therapy Traditionally, voice therapy is delivered on a one-to-one basis, where speech-language pathologists provide therapy to the patients individually. However, our team and other researchers reported that individual voice therapy incurs a higher cost, increases the waiting time for therapy and has a higher therapy dropout rate. In particular, poor therapy attendance rate not only jeopardizes clinical outcomes but also wastes healthcare resources.
  6. Group voice therapy is effective and has many benefits Recent studies, including a treatment study by our team, showed that voice therapy when delivered in groups are as effective as individual therapy. In addition to offsetting the disadvantages of individual therapy, our study and other researchers also showed that group voice therapy provided psychosocial support to the group members and facilitated better therapy skills acquisition through group learning. Furthermore, our team also showed that, when a positive group climate is developed, it could lead to better treatment outcome and could reduce therapy dropout rate. Group climate is the patient's perception of therapeutic relationship in the group therapy environment.
  7. Delivering voice therapy via telepractice In addition to the individual and group model of service delivery, voice therapy has also been extended into telepractice. Our team was among the first to introduce and provide preliminary evidence to support the use of telepractice in voice therapy for patients with MTD.
  8. The reason for telepractice voice therapy Telepractice was initially applied to voice therapy with the aim to reduce service access barriers due to traveling requirements, work commitments and access to experienced clinicians and patient mobility. However, due to the arrival of COVID-19 pandemic, social distancing policies and lockdowns have caused an abrupt disruption of all in-person voice therapy programs. This has left thousands of patients worldwide without any treatment and hence has prolonged and aggravated the negative impact on their professional careers and emotional well-being. Even for those who can attend in-person voice therapy, they are likely to be required to wear masks to mitigate COVID-19 transmission risk. It is important to understand that mask wearing can affect a person's voice quality and production. As such, the treatment effect would unavoidably be impacted.
  9. The urgent need for evidence to support telepractice voice therapy. However, after these initial preliminary findings, no further research on telepractice voice therapy for MTD was conducted. Not until the arrival of COVID-19 pandemic since 2019, researchers and clinicians see the urgency to substantiate the efficacy of telepractice due to its increasing demands and utilization across the globe. Nevertheless, with the limited studies available, researchers were only able to publish recommendation guidelines to guide clinicians in providing voice therapy via telepractice.
  10. A lack of study on telepractice voice therapy for MTD and on group therapy

Following the preliminary studies on telepractice voice therapy published in 2015, only two additional studies were found in the literature on telepractice voice therapy. Although both studies showed that the effectiveness of telepractice voice therapy is comparable to face-to-face therapy, they were provided on an individual basis and on different clinical populations. One study focused on the elderly population with various types of voice disorders and the other study focused on voice prevention for those who are at risk at developing voice disorder.

To date, there are no high-quality clinical trials investigating the effectiveness of telepractice voice therapy for patients with MTD, especially when delivered in a group model.

Being tested
Telepractice group voice therapy, Face-to-face group voice therapy
Keywords
Voice Disorders, Muscle Tension Dysphonia, Group Therapy, Telepractice, Service Delivery Model of Voice Therapy, Voice Therapy, Randomised controlled trail
Medical subject headings
Voice Disorders, Aphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telepractice group voice therapyBehavioural

    • Voice therapy delivered in group basis via telepractice.
    • The voice therapy program will include both indirect and direct voice therapy, in accordance with the current best practice recommendations. Indirect voice therapy will include information counselling on voice production and disorder and vocal hygiene. Direct voice therapy will adopt the resonant voice therapy approach and also head and neck relaxation exercises, which has shown to be effective for muscle tension dysphonia.

  • Face-to-face group voice therapyBehavioural

    • Voice therapy that will be delivered in group basis in-person with patients.
    • The voice therapy program will include both indirect and direct voice therapy, in accordance with the current best practice recommendations. Indirect voice therapy will include information counselling on voice production and disorder and vocal hygiene. Direct voice therapy will adopt the resonant voice therapy approach and also head and neck relaxation exercises, which has shown to be effective for muscle tension dysphonia.
Study groups in NCT06524193
Study groupRoleWhat they receive
Telepractice group voice therapyExperimentalVoice therapy delivered in group basis via telepractice.
Receives: Behavioral: Telepractice group voice therapy
Face-to-face group voice therapyActive comparatorVoice therapy that will be delivered in group basis in-person with patients.
Receives: Behavioral: Face-to-face group voice therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in patient-related outcome measure

    The Chinese Voice-Handicap Index (VHI-30) is a reliable patient-related outcome measure. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. VHI-30 has 30 items. Each item is rated on a scale from with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.

    Statistical analysis: Two-way repeated measures of ANOVA to compare between group performance. To allow for non-inferiority analysis, the 95% confidence interval of the difference in VHI scores between the two groups will be calculated. The upper limit of the 95% CI will be used to determine whether the difference between group is within the non-inferiority margin.

    Measured: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up

  2. Change in laryngeal imaging

    Videostroboscopy will be conducted to identify anatomical and physiological outcomes. These include presence of laryngeal pathology, laryngeal physiological patterns. Two experienced laryngologists blinded to the patient's information will rate the video recordings.

    Statistical analysis: Reliability measures will be applied using intraclass correlation for both intra and interrater reliability. Perceptual evaluation of voice will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.

    Measured: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up

  3. Change in perceptual evaluation of voice

    Patients' voice quality will be assessed using the Cantonese Perceptual Evaluation of Voice scale (Thomas Law, Lee, Lam, van Hasselt, \& Tong, 2013). Two experienced speech-language pathologists blinded to the patient's information will rate the audio recordings.

    Statistical analysis: Reliability measures will be applied using intraclass correlation for both intra and interrater reliability. Perceptual evaluation of voice will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.

    Measured: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up

  4. Change in acoustic voice analysis

    The Computerized Speech Lab system will be used to measure parameters including jitter, shimmer, and noise-to-harmonic ratio and cepstral peak prominence.

    Statistical analysis: Acoustic analysis will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.

    Measured: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up

  5. Change in aerodynamic measures

    Maximum phonation time will be measured.

    Statistical analysis: Aerodynamic measure will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.

    Measured: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up

Secondary outcomes (3)

  1. Therapy dropout rate and treatment schedule adherence rate

    This will be measured by comparing the proportion of patient dropout and non-adherence to treatment schedule in both modes of treatment.

    Statistical analysis will be conducted using the Z-test.

    Measured: Immediately after the intervention

  2. Cost analysis

    This will follow the cost analysis approach suggested by Burns and colleagues. Cost domains including human resource cost, patient cost and equipment cost.

    Statistical analysis will be conducted using the t-test.

    Measured: Immediately after the intervention

  3. Group climate

    The group climate questionnaire will be used to measure the therapeutic relationship at the final session of each therapy group.

    Statistical analysis: the contribution of group climate to treatment outcome will be measured using correlation analysis and one-way repeated ANOVA.

    Measured: Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start25 Jun 2024
  3. Primary completionMay 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06524193
Sponsor's protocol ID
CREC Ref. No.: 2022.378
Other IDs
Project No. CUHK 14106422
Status last verified
Jul 2024
First submitted
21 May 2024
Last updated
29 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abrahamsson M, Millgard M, Havstam C, Tuomi L. Effects of Voice Therapy: A Comparison Between Individual and Group Therapy. J Voice. 2018 Jul;32(4):437-442. doi: 10.1016/j.jvoice.2017.06.008. Epub 2017 Jul 18.

    PubMed 28732752

  • Altman KW, Atkinson C, Lazarus C. Current and emerging concepts in muscle tension dysphonia: a 30-month review. J Voice. 2005 Jun;19(2):261-7. doi: 10.1016/j.jvoice.2004.03.007.

    PubMed 15907440

  • Becker DR, Gillespie AI. In the Zoom Where It Happened: Telepractice and the Voice Clinic in 2020. Semin Speech Lang. 2021 Jan;42(1):64-72. doi: 10.1055/s-0040-1722750. Epub 2021 Feb 17.

    PubMed 33596605

  • Burns CL, Kularatna S, Ward EC, Hill AJ, Byrnes J, Kenny LM. Cost analysis of a speech pathology synchronous telepractice service for patients with head and neck cancer. Head Neck. 2017 Dec;39(12):2470-2480. doi: 10.1002/hed.24916. Epub 2017 Sep 30.

    PubMed 28963804

  • Cantarella G, Torretta S, Ferruta S, Ciabatta A, Manfredi C, Pignataro L, Dejonckere P. Multidimensional Assessment of the Effectiveness of Group Voice Therapy. J Voice. 2017 Nov;31(6):714-721. doi: 10.1016/j.jvoice.2017.02.004. Epub 2017 Mar 1.

    PubMed 28259606

  • Castillo-Allendes A, Contreras-Ruston F, Cantor-Cutiva LC, Codino J, Guzman M, Malebran C, Manzano C, Pavez A, Vaiano T, Wilder F, Behlau M. Voice Therapy in the Context of the COVID-19 Pandemic: Guidelines for Clinical Practice. J Voice. 2021 Sep;35(5):717-727. doi: 10.1016/j.jvoice.2020.08.001. Epub 2020 Aug 7.

    PubMed 32878736

  • DeVore EK, Carroll TL, Rosner B, Shin JJ. Can voice disorders matter as much as life-threatening comorbidities to patients' general health? Laryngoscope. 2020 Oct;130(10):2405-2411. doi: 10.1002/lary.28417. Epub 2019 Dec 3.

    PubMed 31794064

  • Eastwood C, Madill C, Mccabe P. The behavioural treatment of muscle tension voice disorders: A systematic review. Int J Speech Lang Pathol. 2015 Jun;17(3):287-303. doi: 10.3109/17549507.2015.1024169. Epub 2015 May 8.

    PubMed 25953458

  • Lin FC, Chien HY, Chen SH, Kao YC, Cheng PW, Wang CT. Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-Face Therapy. J Speech Lang Hear Res. 2020 Jul 20;63(7):2132-2140. doi: 10.1044/2020_JSLHR-19-00364. Epub 2020 Jun 24.

    PubMed 32579859

  • Fu S, Theodoros DG, Ward EC. Delivery of Intensive Voice Therapy for Vocal Fold Nodules Via Telepractice: A Pilot Feasibility and Efficacy Study. J Voice. 2015 Nov;29(6):696-706. doi: 10.1016/j.jvoice.2014.12.003. Epub 2015 Feb 26.

    PubMed 25726070

  • Fu S, Theodoros DG, Ward EC. Intensive versus traditional voice therapy for vocal nodules: perceptual, physiological, acoustic and aerodynamic changes. J Voice. 2015 Mar;29(2):260.e31-44. doi: 10.1016/j.jvoice.2014.06.005. Epub 2014 Oct 12.

    PubMed 25311594

  • Grillo EU. Building a Successful Voice Telepractice Program. Perspect ASHA Spec Interest Groups. 2019 Feb;4(1):100-110. doi: 10.1044/2018_PERS-SIG3-2018-0014.

    PubMed 31544152

  • Grillo EU. A Nonrandomized Trial for Student Teachers of an In-Person and Telepractice Global Voice Prevention and Therapy Model With Estill Voice Training Assessed by the VoiceEvalU8 App. Am J Speech Lang Pathol. 2021 Mar 26;30(2):566-583. doi: 10.1044/2020_AJSLP-20-00200. Epub 2021 Feb 1.

    PubMed 33524262

  • Hapner E, Portone-Maira C, Johns MM 3rd. A study of voice therapy dropout. J Voice. 2009 May;23(3):337-40. doi: 10.1016/j.jvoice.2007.10.009.

    PubMed 18674882

  • Iwarsson J. Facilitating behavioral learning and habit change in voice therapy--theoretic premises and practical strategies. Logoped Phoniatr Vocol. 2015 Dec;40(4):179-86. doi: 10.3109/14015439.2014.936498. Epub 2014 Jul 23.

    PubMed 25054888

Questions about this trial

What is this clinical trial studying?

A study testing Telepractice group voice therapy and Face-to-face group voice therapy in people with Voice Disorders and Muscle Tension Dysphonia, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Thomas Law, PhD ((852) 39439601, thomaslaw@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patient-related outcome measure (time frame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06524193, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.

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