Comprehensive Voice Rehabilitation Program Compared With Vocal Function Exercises

Early Phase 1

Completed

• Conditions: Dysphonia
• Interventions: Behavioral: Voice therapy

• Registration Number: NCT02409758
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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.

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2011-12
• Study Completion: 2012-08
• Study First Submitted: 2015-03-19
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-06
• Last Update Submitted: 2015-04-06
• Study First Posted: 2015-04-07
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVRP voice therapy	Voice therapy	Voice therapy: Comprehensive Voice Rehabilitation Program applied during 6 weeks
VFE voice therapy	Voice therapy	Voice therapy: Vocal Function Exercises applied during 6 weeks

Primary Outcome Measures

Name	Time	Method
Improvement of the vocal quality (assessed by two self assessment questionnaires)	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

Secondary Outcome Measures

Name	Time	Method
Improvement of larynx (evaluation by blind assessor)	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.
Perceptual auditory analysis (assessed by 3 senior SLP)	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.