Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

March 28, 2017 updated by: Leticia Caldas Teixeira, Federal University of São Paulo
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Universidade Federal de São Paulo

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

21 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
EXPERIMENTAL: Voice amplification
Behavioral: Voice amplification Patients will use VA over a course of 6 weeks.
Behavioral: Voice Amplification
Behavioral: Voice Amplification. Patients use VA over a course of 6 weeks Control group. No treatment over a course of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fiberoptic endoscopic evaluation
Time Frame: One year
One year
Score(CAPE_V); score(PPAV); score on acoustic analysis
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

Federal University of São Paulo

Collaborators

Federal University of Minas Gerais

Investigators

  • Study Director: Mara S Behlau, PhD, Universidade Federal de São Paulo
  • Study Director: Arnaldo L Colombo, PhD, Federal University of São Paulo
  • Principal Investigator: Letícia C Teixeira, MsC, Federal University of São Paulo
  • Study Director: Ana Cristina C Gama, D, Federal University of Minas Gerais

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

September 1, 2010

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (ESTIMATE)

September 8, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETIC 0521.0.203.000-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data of the participants are confidential

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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