Abstract
BACKGROUND: Muscle tension dysphonia (MTD) results from inefficient or ineffective voice production and is the cause of voice and throat complaints in up to 40% of patients presenting with hoarseness. Standard treatment is voice therapy (SLT-VT) delivered by specialist speech therapists in voice disorders (SLT-V). The Complete Vocal Technique (CVT) is a structured, pedagogic method which helps healthy singers and other performers optimise their vocal function enabling them to produce any sound required. The aim of this feasibility study is to investigate whether CVT administered by a trained, non-clinical CVT practitioner (CVT-P) can be applied to patients with MTD before progressing to a pilot randomised control study of CVT voice therapy (CVT-VT) versus SLT-VT. METHODS/DESIGN: In this feasibility study, we use a mixed-method, single-arm, prospective cohort design. The primary aim is to demonstrate whether CVT-VT can improve the voice and vocal function in patients with MTD in a pilot study using multidimensional assessment methods. Secondary aims are to assess whether (1) a CVT-VT study is feasible to perform; (2) is acceptable to patients, the CVT-P and SLT-VTs; and (3) whether CVT-VT differs from existing SLT-VT techniques. A minimum of 10 consecutive patients with a clinical diagnosis of primary MTD (types I-III) will be recruited over a 6-month period. Up to 6 video sessions of CVT-VT will be delivered by a CVT-P using a video link. The primary outcome will be a change in pre-/post-therapy scores of a self-reported patient questionnaire (Voice Handicap Index (VHI)). Secondary outcomes include changes in throat symptoms (Vocal Tract Discomfort Scale), acoustic/electroglottographic and auditory-perceptual measures of voice. Acceptability of the CVT-VT will be assessed prospectively, concurrently and retrospectively both quantitatively and qualitatively. Differences from SLT-VT will be assessed by performing a deductive thematic analysis of CVT-P transcripts of therapy sessions. CONCLUSION: This feasibility study will provide important data to support whether to proceed with a randomised controlled pilot study focusing on the effectiveness of the intervention compared to standard SLT-VT. Progression criteria will be based on demonstrating a positive outcome in treatment, successful delivery of the pilot study protocol, acceptability to all stakeholders and satisfactory recruitment rates. TRIAL REGISTRATION: ClinicalTrials.gov website ( NCT05365126 Unique Protocol ID: 19ET004). Registered on 06 May 2022.