The Role of Voice Rest on Voice Outcomes Following Phonosurgery

Not Applicable

• Conditions: Unilateral Vocal Cord Lesions
• Interventions: Behavioral: Absolute Voice Rest

• Registration Number: NCT02788435
• Lead Sponsor: Lawson Health Research Institute

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-02
• Study Start: 2016-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age greater than 18 years
• Unilateral vocal cord lesion
• Consented for phonosurgery

Read More

Exclusion Criteria

• Age less than 18 years
• Bilateral vocal cord lesions
• Prior vocal cord surgery

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absolute Voice Rest	Absolute Voice Rest	Patients in the experimental arm will undergo 7 days of absolute voice rest following surgery.

Primary Outcome Measures

Name	Time	Method
Voice Handicap Index (VHI)-10	12 weeks post-operative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada