The Role of Voice Rest on Voice Outcomes Following Phonosurgery: A Randomized-Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Voice Handicap Index (VHI)-10
Study Overview
Brief Summary
Patients undergoing vocal cord surgery (phonosurgery) are often prescribed voice rest postoperatively. However, no clinical trials have ever been conducted to ascertain the efficacy of using voice rest and its impact on functional voice outcomes. The purpose of this randomized-clinical trial is to determine if the prescription of voice rest has an impact on voice outcomes following phonosurgery.
Detailed Description
The study will seek to determine if a 7-day period of absolute voice rest alters voice-related quality of life following phonosurgery
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than 18 years
- •Unilateral vocal cord lesion
- •Consented for phonosurgery
Exclusion Criteria
- •Age less than 18 years
- •Bilateral vocal cord lesions
- •Prior vocal cord surgery
Arms & Interventions
Control
Patients in the control arm will undergo a graduated prescription of voice use immediately following surgery.
Absolute Voice Rest
Patients in the experimental arm will undergo 7 days of absolute voice rest following surgery.
Intervention: Absolute Voice Rest (Behavioral)
Outcomes
Primary Outcomes
Voice Handicap Index (VHI)-10
Time Frame: 12 weeks post-operative
Voice Handicap Index (VHI)-10
Time Frame: 4 weeks post-operative
Secondary Outcomes
- Frequency perturbation (jitter)(12 weeks post-operative)
- Fundamental frequency(12 weeks post-operative)
- Maximum phonation time(12 weeks post-operative)
- Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale(12 weeks post-operative)
- Amplitude perturbation (shimmer)(12 weeks post-operative)
- Fundamental frequency(4 weeks post-operative)
- Maximum phonation time(4 weeks post-operative)
- Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale(4 weeks post-operative)
- Amplitude perturbation (shimmer)(4 weeks post-operative)
- Frequency perturbation (jitter)(4 weeks post-operative)