Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Federal University of Minas Gerais
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01196611
First received: September 3, 2010
Last updated: September 7, 2010
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). 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.

H1 - Both approaches produce positive voice changes, but the VFE will produce more changes. H2 - Only VFE are effective for teachers with voice disorders.

H3 - Both approaches produce similar changes. H4 - Null Hypothesis.


Condition Intervention Phase
Voice Disorders
Behavioral: Voice Amplification
Behavioral: Function Voice Exercises
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Federal University of São Paulo:

Primary Outcome Measures:
  • Fiberoptic endoscopic evaluation [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Score(CAPE_V); score(PPAV); score on acoustic analysis [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 162
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders 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

No publications provided

Responsible Party: Letícia Caldas Teixeira, Universidade Federal de Sao 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: September 7, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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 October 16, 2014