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The Role of Voice Rest on Voice Outcomes Following Phonosurgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02788435
Enrollment
50
Registered
2016-06-02
Start date
2016-07-31
Completion date
2019-06-30
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Vocal Cord Lesions

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

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Voice Handicap Index (VHI)-104 weeks post-operative

Secondary

MeasureTime frame
Frequency perturbation (jitter)4 weeks post-operative
Amplitude perturbation (shimmer)4 weeks post-operative
Fundamental frequency4 weeks post-operative
Maximum phonation time4 weeks post-operative
Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale4 weeks post-operative

Countries

Canada

Contacts

Primary ContactKevin Fung, MD, FRCSC
Kevin.Fung@lhsc.on.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026