Comprehensive Voice Rehabilitation Program Compared With Vocal Function Exercises

NCT ID: NCT02409758

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Dysphonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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VFE voice therapy

Voice therapy: Vocal Function Exercises applied during 6 weeks

Group Type ACTIVE_COMPARATOR

Voice therapy

Intervention Type BEHAVIORAL

Voice therapy applied during 6 weeks.

CVRP voice therapy

Voice therapy: Comprehensive Voice Rehabilitation Program applied during 6 weeks

Group Type EXPERIMENTAL

Voice therapy

Intervention Type BEHAVIORAL

Voice therapy applied during 6 weeks.

Interventions

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Voice therapy

Voice therapy applied during 6 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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Voice treatment SLP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Vanessa Pedrosa Vieira

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vanessa P Vieira, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

References

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Ziegler A, Gillespie AI, Abbott KV. Behavioral treatment of voice disorders in teachers. Folia Phoniatr Logop. 2010;62(1-2):9-23. doi: 10.1159/000239059. Epub 2010 Jan 8.

Reference Type BACKGROUND
PMID: 20093840 (View on PubMed)

MacKenzie K, Millar A, Wilson JA, Sellars C, Deary IJ. Is voice therapy an effective treatment for dysphonia? A randomised controlled trial. BMJ. 2001 Sep 22;323(7314):658-61. doi: 10.1136/bmj.323.7314.658.

Reference Type RESULT
PMID: 11566828 (View on PubMed)

Niebudek-Bogusz E, Sznurowska-Przygocka B, Fiszer M, Kotylo P, Sinkiewicz A, Modrzewska M, Sliwinska-Kowalska M. The effectiveness of voice therapy for teachers with dysphonia. Folia Phoniatr Logop. 2008;60(3):134-41. doi: 10.1159/000120290. Epub 2008 Mar 12.

Reference Type RESULT
PMID: 18334848 (View on PubMed)

Other Identifiers

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2010/15166-3

Identifier Type: OTHER

Identifier Source: secondary_id

2010/15166-3

Identifier Type: -

Identifier Source: org_study_id

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