The Role of Voice Rest on Voice Outcomes Following Phonosurgery

August 13, 2018 updated by: Lawson Health Research Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre
        • Contact:
          • Kevin Fung, MD, FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients in the control arm will undergo a graduated prescription of voice use immediately following surgery.
Experimental: Absolute Voice Rest
Patients in the experimental arm will undergo 7 days of absolute voice rest following surgery.
Behavioral: Absolute Voice Rest
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Kevin Fung, MD, FRCSC, Department of Otolaryngology - Head & Neck Surgery, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 107893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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