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

Not Applicable

Recruiting

• Conditions: Voice Disorders; Muscle Tension Dysphonia; Aphonia
• Interventions: Behavioral: Telepractice group voice therapy; Behavioral: Face-to-face group voice therapy

• Registration Number: NCT06524193
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

* 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.

Detailed Description

STUDY OBJECTIVES

1. Primary Objectives

1. To evaluate the effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design.

2. To evaluate the effectiveness of telepractice group voice therapy using a randomized controlled trial study design.

2. Secondary Objectives

1. 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).

2. To conduct cost-analysis to compare the health-service cost and patient-related cost of the telepractice and face-to-face group voice therapy.

3. To further investigate the role of group climate in contributing to treatment outcome in group voice therapy.

BACKGROUND

1. Muscle tension dysphonia

1. 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.

2. 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.

2. 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.

1. 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.

2. 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.

3. 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.

1. 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.

2. 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.

4. 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.

Study Timeline

• Study First Submitted: 2024-05-21
• Study Start: 2024-06-25
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29
• Primary Completion: 2026-05
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telepractice group voice therapy	Telepractice group voice therapy	Voice therapy delivered in group basis via telepractice.
Face-to-face group voice therapy	Face-to-face group voice therapy	Voice therapy that will be delivered in group basis in-person with patients.

Primary Outcome Measures

Name	Time	Method
Change in patient-related outcome measure	Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up	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.
Change in acoustic voice analysis	Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up	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.
Change in laryngeal imaging	Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up	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.
Change in perceptual evaluation of voice	Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up	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.
Change in aerodynamic measures	Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Therapy dropout rate and treatment schedule adherence rate	Immediately after the intervention	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.
Group climate	Immediately after the intervention	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.
Cost analysis	Immediately after the intervention	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.

Trial Locations

Locations (1)

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