RCT Face-to-face Group Voice Therapy vs Telepractice Group Voice Therapy for Muscle Tension Dysphonia
NCT Number: NCT06524193
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Voice Disorders|Muscle Tension Dysphonia|Aphonia
Interventions: BEHAVIORAL: Telepractice group voice therapy|BEHAVIORAL: Face-to-face group voice therapy
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 168
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2026-07
Locations: Division of Speech Therapy, Dept of Otorhinolaryngology , Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong, Hong Kong

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.

Primary Outcome Measures: 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., Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up|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., Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up|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., Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up|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., Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up|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., Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
Secondary Outcome Measures: 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., Immediately after the intervention|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., Immediately after the intervention|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., Immediately after the intervention