The Role of Voice Rest on Voice Outcomes Following Phonosurgery
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2016
CompletedFirst Posted
Study publicly available on registry
June 2, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedAugust 15, 2018
August 1, 2018
2.4 years
May 16, 2016
August 13, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Voice Handicap Index (VHI)-10
4 weeks post-operative
Voice Handicap Index (VHI)-10
12 weeks post-operative
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONPatients in the control arm will undergo a graduated prescription of voice use immediately following surgery.
Absolute Voice Rest
EXPERIMENTALPatients in the experimental arm will undergo 7 days of absolute voice rest following surgery.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age greater than 18 years
- Unilateral vocal cord lesion
- Consented for phonosurgery
You may not qualify if:
- Age less than 18 years
- Bilateral vocal cord lesions
- Prior vocal cord surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Related Publications (1)
Dhaliwal SS, Doyle PC, Failla S, Hawkins S, Fung K. Role of voice rest following laser resection of vocal fold lesions: A randomized controlled trial. Laryngoscope. 2020 Jul;130(7):1750-1755. doi: 10.1002/lary.28287. Epub 2019 Sep 9.
PMID: 31498467DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Fung, MD, FRCSC
Department of Otolaryngology - Head & Neck Surgery, Western University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2016
First Posted
June 2, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2018
Study Completion
June 1, 2019
Last Updated
August 15, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share