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Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

This study has been completed.
Sponsor:
Collaborator:
Federal University of Minas Gerais
Information provided by (Responsible Party):
Leticia Caldas Teixeira, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01196611
First received: September 3, 2010
Last updated: March 28, 2017
Last verified: September 2010
  Purpose
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).

Condition Intervention
Voice Disorders Behavioral: Voice Amplification Behavioral: Function Voice Exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

Resource links provided by NLM:


Further study details as provided by Leticia Caldas Teixeira, Federal University of São Paulo:

Primary Outcome Measures:
  • Fiberoptic endoscopic evaluation [ Time Frame: One year ]
  • Score(CAPE_V); score(PPAV); score on acoustic analysis [ Time Frame: One year ]

Enrollment: 162
Study Start Date: September 2010
Study Completion Date: March 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196611

Locations
Brazil
Universidade Federal de Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
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
  More Information

Responsible Party: Leticia Caldas Teixeira, Professor/PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01196611     History of Changes
Other Study ID Numbers: ETIC 0521.0.203.000-09
Study First Received: September 3, 2010
Last Updated: March 28, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: The data of the participants are confidential

Keywords provided by Leticia Caldas Teixeira, Federal University of São Paulo:
Voice disorders
Voice

Additional relevant MeSH terms:
Disease
Voice Disorders
Pathologic Processes
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 28, 2017