The Role of Voice Rest on Voice Outcomes Following Phonosurgery

NCT ID: NCT02788435

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-06-30

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

Conditions

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Unilateral Vocal Cord Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Patients in the control arm will undergo a graduated prescription of voice use immediately following surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Absolute Voice Rest

Patients in the experimental arm will undergo 7 days of absolute voice rest following surgery.

Group Type EXPERIMENTAL

Absolute Voice Rest

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Fung, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Department of Otolaryngology - Head & Neck Surgery, Western University

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Kevin Fung, MD, FRCSC

Role: CONTACT

Facility Contacts

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Kevin Fung, MD, FRCSC

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31498467 (View on PubMed)

Other Identifiers

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107893

Identifier Type: -

Identifier Source: org_study_id

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