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Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

Primary Purpose

Voice Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Voice Amplification
Function Voice Exercises
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Voice Disorders focused on measuring Voice disorders, Voice

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade Federal de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Function Voice Exercises

Voice amplification

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fiberoptic endoscopic evaluation
Score(CAPE_V); score(PPAV); score on acoustic analysis

Secondary Outcome Measures

Full Information

First Posted
September 3, 2010
Last Updated
March 28, 2017
Sponsor
Federal University of São Paulo
Collaborators
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT01196611
Brief Title
Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders
Official Title
Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice Disorders
Keywords
Voice disorders, Voice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Function Voice Exercises
Arm Type
Experimental
Arm Description
Behavioral: Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week.
Arm Title
Voice amplification
Arm Type
Experimental
Arm Description
Behavioral: Voice amplification Patients will use VA over a course of 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Voice Amplification
Intervention Description
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
Intervention Name(s)
Function Voice Exercises
Intervention Description
Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week.
Primary Outcome Measure Information:
Title
Fiberoptic endoscopic evaluation
Time Frame
One year
Title
Score(CAPE_V); score(PPAV); score on acoustic analysis
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara S Behlau, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arnaldo L Colombo, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Letícia C Teixeira, MsC
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Cristina C Gama, D
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data of the participants are confidential

Learn more about this trial

Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

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