Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders
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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 |
- 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 |
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| Brazil | |
| Universidade Federal de Sao Paulo | |
| Sao Paulo, Brazil | |
| 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:
|
Voice Disorders Laryngeal Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013