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临床试验/NCT01196611
NCT01196611已完成不适用

Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
162
试验地点
1
主要终点
Fiberoptic endoscopic evaluation

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Physical education or daycare teachers.
  • Professional singers.
  • Neurological and/or psychiatric voice disorders

结局指标

主要结局

Fiberoptic endoscopic evaluation

时间窗: One year

Score(CAPE_V); score(PPAV); score on acoustic analysis

时间窗: One year

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leticia Caldas Teixeira

Professor/PhD

Federal University of São Paulo

研究点 (1)

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