The Role of Voice Rest on Voice Outcomes Following Phonosurgery

Study Overview
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Brief Summary
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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
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The study will seek to determine if a 7-day period of absolute voice rest alters voice-related quality of life following phonosurgery

Official Title
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The Role of Voice Rest on Voice Outcomes Following Phonosurgery: A Randomized-Controlled Trial

Conditions
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Unilateral Vocal Cord Lesions

Intervention / Treatment
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* Behavioral: Absolute Voice Rest


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients in the control arm will undergo a graduated prescription of voice use immediately following surgery. | |
| Experimental: Absolute Voice Rest<br>Patients in the experimental arm will undergo 7 days of absolute voice rest following surgery. | Behavioral: Absolute Voice Rest<br>* Patients will be instructed to not use their voice and minimize any voice-use activities such as coughing or throat-clearing for a period of 7 days following surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice Handicap Index (VHI)-10 |  | 4 weeks post-operative | 
| Voice Handicap Index (VHI)-10 |  | 12 weeks post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency perturbation (jitter) |  | 4 weeks post-operative | 
| Frequency perturbation (jitter) |  | 12 weeks post-operative | 
| Amplitude perturbation (shimmer) |  | 4 weeks post-operative | 
| Amplitude perturbation (shimmer) |  | 12 weeks post-operative | 
| Fundamental frequency |  | 4 weeks post-operative | 
| Fundamental frequency |  | 12 weeks post-operative | 
| Maximum phonation time |  | 4 weeks post-operative | 
| Maximum phonation time |  | 12 weeks post-operative | 
| Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale |  | 4 weeks post-operative | 
| Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale |  | 12 weeks post-operative |