Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

NCT ID: NCT01196611

Last Updated: 2017-03-30

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

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-03-31

Brief Summary

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The study compares two different approaches of voice therapy. Vocal Functional Exercises (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II - Tecnisystem do Brasil TSI 1210).

Detailed Description

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Both approaches combined with Vocal Hygiene Program (Behlau, 2007).The target population are female teachers because they have the highest risk for developing voice problems. For this study the investigators are primarily interested in seeing if Vocal Functional Exercises and Voice Amplification are equally effective at improving vocal functioning in teachers with voice disorders. The Fiberoptic endoscopic evaluation will be done before randomization. All the participants will complete before and after a 6-week treatment phase (a) Voice Activity and Participation Profile (PPAV), an instrument designed to appraise the self-perceived psychosocial consequences of voice disorders to assess the impact of voice disorders on daily activities (b) Audio voice recording for later acoustic analysis, through the Kay Elemetrics Multi Dimensional Voice Program (c) Audio recording for later perceptual analysis through Consensus Auditory-Perceptual Evaluation of Voice (CAPE\_V). It is believed that the search for evidence in clinical studies like this can contribute to awareness programs and vocal training for teachers.

Conditions

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Voice Disorders

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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Function Voice Exercises

Behavioral: Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week.

Group Type EXPERIMENTAL

Function Voice Exercises

Intervention Type BEHAVIORAL

Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week.

Voice amplification

Behavioral: Voice amplification Patients will use VA over a course of 6 weeks.

Group Type EXPERIMENTAL

Voice Amplification

Intervention Type BEHAVIORAL

Behavioral: Voice Amplification. Patients use VA over a course of 6 weeks Control group. No treatment over a course of 6 weeks.

Interventions

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Voice Amplification

Behavioral: Voice Amplification. Patients use VA over a course of 6 weeks Control group. No treatment over a course of 6 weeks.

Intervention Type BEHAVIORAL

Function Voice Exercises

Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female teacher
* 21-50 years old.
* Full or part time elementary to middle school teacher ( Prefeitura Municipal de Belo Horizonte).
* Minimum 20 hour weekly workload.
* Medical reference to speech therapy due to behavioral dysphonia

Exclusion Criteria

* Physical education or daycare teachers.
* Professional singers.
* Neurological and/or psychiatric voice disorders
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Leticia Caldas Teixeira

Professor/PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mara S Behlau, PhD

Role: STUDY_DIRECTOR

Universidade Federal de São Paulo

Arnaldo L Colombo, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Letícia C Teixeira, MsC

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Ana Cristina C Gama, D

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Locations

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Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ETIC 0521.0.203.000-09

Identifier Type: -

Identifier Source: org_study_id

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