Intensive Versus Traditional Voice Therapy

Dysphonia Clinical Trial

Official title:

Voice-related Outcomes in Response to Intensive Versus Traditional Therapy Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129880
• Other study ID #: 2015-0763
• Secondary ID: A539772SMPH/SURG
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dysphonia

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