Division of Speech Therapy, Dept of Otorhinolaryngology , Head and Neck Surgery, The Chinese University of Hong Kong
Hong Kong
Location status: Recruiting
NCT Number: NCT06524193
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hong Kong
Location status: Recruiting
STUDY OBJECTIVES
BACKGROUND
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.
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.
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.
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.
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Thomas Law, PhD
CONTACT
Yifeng Wei, Master
CONTACT
Chinese University of Hong Kong
Other
Comparing Face-to-face Group Voice Therapy to Telepractice Group Voice Therapy for Muscle Tension Dysphonia: A Non-inferiority Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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