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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03129880
Other study ID # 2015-0763
Secondary ID A539772SMPH/SURG
Status Completed
Phase N/A
First received
Last updated
Start date March 13, 2016
Est. completion date March 12, 2024

Study information

Verified date May 2024
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if there are differences in treatment outcomes between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive voice therapy, consisting of 4-6 therapy sessions performed within one day.


Description:

The goal of voice therapy is optimal long-term vocal quality and communication function with minimal recurrence. Traditional voice therapy for dysphonia typically consists of one to two therapy sessions each week with a single clinician for about 8 weeks. Another approach of voice therapy is intensive short-term therapy also known as "boot camp." This approach, borrows from the disciplines of neurobiology, exercise physiology, motor learning, and psychotherapy which describe desirable learning and behavior changes influenced by practice that involves high-intensity overload, variability, and specificity of training. A few studies have showed that "Boot Camp" model of intensive therapy resulted in comparable gains in voice quality and vibratory mechanics and may promote better patient satisfaction and attendance. While such findings support the notion that intensive voice therapy may enhance voice therapy outcomes, no study to date has examined patient response to the "Boot Camp" approach to voice therapy. The investigators will compare the outcomes of traditional, weekly voice therapy and intensive voice therapy with multiple sessions in one day.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 12, 2024
Est. primary completion date March 12, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with a Voice disorder - Diagnosed with benign vocal fold lesions and/or hyper-function - First/primary propose treatment modality is voice therapy - Patients who are appropriate for either standard of care treatment modality (traditional or intensive voice therapy) - Willingness to participate in either standard of care treatment modality - All races - Males and females - English speaking Exclusion Criteria: - Younger than 18 - Inability or unwillingness to participate in one of the standard of care treatment modalities - Laryngeal Surgery or procedures during course of study - Prisoners

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Weekly Voice Therapy
Participants will be randomized to receive weekly voice therapy
Intensive Voice Therapy
Participants will be randomized to receive multiple sessions of voice therapy in one day.

Locations

Country Name City State
United States University of Wisconsin-Madison Voice and Swallow Clinic Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-efficacy and readiness scale Changes Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely) Baseline compared to Immediately post voice therapy
Primary Self-efficacy and readiness scale Change Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely) Baseline compared to 12 weeks post voice therapy
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