Comprehensive Voice Rehabilitation Program Compared With Vocal Function Exercises (Voicetherapy)

April 6, 2015 updated by: Vanessa Pedrosa Vieira, Federal University of São Paulo

The Effectiveness of the Comprehensive Voice Rehabilitation Program Compared With Vocal Function Exercises Method in Behavioral Dysphonia: A Randomized Controlled Clinical Trial.

The purpose of this study is to evaluate the effectiveness and safety of the Comprehensive Voice Rehabilitation Program compared with Vocal Function Exercises in behavioral dysphonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: Voice therapy is the best indication for the most voice disorders, with a strong degree of recommendation based on systematic reviews and randomized clinical trials, with a predominance of benefit over risk. Some speech therapy techniques are specific, others are organized principles or with eclectic approaches, that use a combination of strategies. So far, few studies have tested the effectiveness of treatment for dysphonia due to time spent, safety and improved quality of life more comprehensive as they are made in clinical. Objective: To evaluate the effectiveness and safety of the Comprehensive Voice Rehabilitation Program compared with Vocal Function Exercises in behavioral dysphonia. Methods: 106 professional of voice with dysphonia behavior, between 18 and 50 years old and vocal complaints for more than six months. These professionals have been evaluated by an otolaryngologist, randomized to participate of Vocal Function Exercises arm or Comprehensive Voice Rehabilitation Program arm. Both arms were follow for six sessions with speech therapists and reassessed when finish the period and after one month. The primary outcomes assessed are: reduction of VHI score, improved voice quality in the CAPE-V and improves the larynx condition. Conclusions: The Comprehensive Voice Program has an eclectic approach and follows the philosophy of what is practiced in clinics in Brazil. We believe this program can demonstrate the power of voice therapy effectiveness more organized to solve problems, with shorter duration of treatment, benefit patient health and funding agencies such as Unified Public Health System (SUS) and health insurance.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • voice professionals with behavioral dysphonia, with or without larynx lesions, with otorhinolaryngologist's indication;
  • over 6 months with vocal complain;
  • 3 or more signs and symptoms in the questionary.

Exclusion Criteria:

  • Other kind of vocal disorder, speech or language disorder, malignant lesions, hormonal disturbances related by the patient, laryngeal papilloma, etc.
  • Singers;
  • neurological problems;
  • acute larynx problem.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: VFE voice therapy
Voice therapy: Vocal Function Exercises applied during 6 weeks
Behavioral: Voice therapy
Voice therapy applied during 6 weeks.
Other Names:
  • SLP
  • Voice treatment
Experimental: CVRP voice therapy
Voice therapy: Comprehensive Voice Rehabilitation Program applied during 6 weeks
Behavioral: Voice therapy
Voice therapy applied during 6 weeks.
Other Names:
  • SLP
  • Voice treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of the vocal quality (assessed by two self assessment questionnaires)
Time Frame: First assesment in the beggining of the treatment; 2nd assesment after 6 weeks of treatment; 3rd assesment a month after the end of treatment.
The improvement was assessed by two questionnaires of self assessment vocal quality: Voice Related Quality of life questionnaire (VRQOL) and Voice Handicap Index (VHI) in the three different moments: pre therapy, post therapy and one month after therapy
First assesment in the beggining of the treatment; 2nd assesment after 6 weeks of treatment; 3rd assesment a month after the end of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceptual auditory analysis (assessed by 3 senior SLP)
Time Frame: First assesment in the beggining of the treatment; 2nd assesment after 6 weeks of treatment; 3rd assesment a month after the end of treatment.
The general grade of hoarseness was assessed blindness by 3 senior SLP in the three different moments: pre therapy, post therapy and one month after therapy. The 3 SLP assessors was blinded according to kind of therapy and moment of evaluation.
First assesment in the beggining of the treatment; 2nd assesment after 6 weeks of treatment; 3rd assesment a month after the end of treatment.
Improvement of larynx (evaluation by blind assessor)
Time Frame: First assesment: in the beggining of the treatment; 2nd assesment: after 6 weeks of treatment; 3rd assesment: a month after the end of treatment.
Evaluation of the larynx by a senior otorhinolaryngologist in the three different moments: pre therapy, post therapy and one month after therapy. The otorhinolaryngologist assessor was blinded according to the kind of therapy and moment of evaluation.
First assesment: in the beggining of the treatment; 2nd assesment: after 6 weeks of treatment; 3rd assesment: a month after the end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Vanessa P Vieira, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/15166-3 (Other Identifier: FAPESP - Brazil)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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