Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

Voice Disorders Clinical Trial

Official title:

Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196611
• Other study ID #: ETIC 0521.0.203.000-09
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: March 28, 2017
• Start date: September 2010
• Est. completion date: March 2013

Study information

• Verified date: September 2010
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: March 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Voice Disorders

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fiberoptic endoscopic evaluation		One year
Primary	Score(CAPE_V); score(PPAV); score on acoustic analysis		One year