RCT Face-to-face Group Voice Therapy vs Telepractice Group Voice Therapy for Muscle Tension Dysphonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Telepractice group voice therapy
Behavioral* 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 therapy
Behavioral* 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.
Treatment groups
168 Participants
are divided into 2 treatment groupsGroup A: Telepractice group voice therapyExperimental treatment 1 intervention
Group B: Face-to-face group voice therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up2
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.
Time frame
Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up3
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.
Time frame
Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up4
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.
Time frame
Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-upSecondary outcomes
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.
Time frame
Immediately after the intervention2
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.
Time frame
Immediately after the intervention3
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.
Time frame
Immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov