Clinical trial NCT06524193: RCT Face-to-face Group Voice Therapy vs Telepractice Group Voice Therapy for Muscle Tension Dysphonia
Official title: Comparing Face-to-face Group Voice Therapy to Telepractice Group Voice Therapy for Muscle Tension Dysphonia: A Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Voice Disorders
Muscle Tension Dysphonia
Aphonia
Keywords: Voice Disorders
Muscle Tension Dysphonia
Group Therapy
Telepractice
Service Delivery Model of Voice Therapy
Voice Therapy
Randomised controlled trail
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Change in patient-related outcome measure
timeFrame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
measure: Change in laryngeal imaging
timeFrame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
measure: Change in perceptual evaluation of voice
timeFrame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
measure: Change in acoustic voice analysis
timeFrame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
measure: Change in aerodynamic measures
timeFrame: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
Secondary outcomes:
measure: Therapy dropout rate and treatment schedule adherence rate
timeFrame: Immediately after the intervention
measure: Cost analysis
timeFrame: Immediately after the intervention
measure: Group climate
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Division of Speech Therapy, Dept of Otorhinolaryngology , Head and Neck Surgery, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Thomas Law, PhD
role: PRINCIPAL_INVESTIGATOR
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