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

Federal University of São Paulo

Status and phase: Completed; Early Phase 1

Conditions: Dysphonia

Treatments: Behavioral: Voice therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02409758

2010/15166-3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

VFE voice therapy

Active Comparator group

Description:

Voice therapy: Vocal Function Exercises applied during 6 weeks

Treatment:

Behavioral: Voice therapy

CVRP voice therapy

Experimental group

Description:

Voice therapy: Comprehensive Voice Rehabilitation Program applied during 6 weeks

Treatment:

Behavioral: Voice therapy