NCT00222937已完成3 期
Efficacy of Voice Therapy for Phonotrauma in Teachers
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Score on Voice Handicap Index (VHI)
研究概览
简要总结
The study compares two different forms of voice therapy, Lessac-Madsen Resonant Voice Therapy and Casper-Based Confidential Flow Therapy. The target population are teachers because they have the highest risk for developing voice problems. For this study the investigators are primarily interested in seeing if Lessac-Madsen Resonant Voice Therapy (LMRVT) and Casper-Based Confidential Flow Therapy (CBCFT) are equally effective at improving vocal functioning in teachers with phonotrauma, as assessed by the Voice Handicap Index (VHI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full or part time teacher including college professor, daycare and preschool
- •21 years of age and older
- •Complaints of voice problems declared to be lasting continuously for one month or more
- •Any structural or functional change to the larynx that appears related to phonation,including bilateral or unilateral lesions (assuming normal overlying epithelium based on clinical examination), non-specific edema, or erythema that appear by clinical history related to phonation, or primary muscle tension dysphonia or other condition related to phonation without lesions
- •No concurrent ear, nose and/or throat diagnoses, e.g. acute allergies, except for chronic allergies, sinusitis, and laryngopharyngeal reflux disease (LPR)
- •No vocal fold hemorrhage
- •No known degenerative medical conditions (e.g., degenerative neuromuscular disease, malignant process undergoing treatment or with less than 5 years remission, uncontrolled systemic disease (e.g., auto immune disease, or hormonal condition)
- •Normal hearing to 30 dB at 1000Hz - 3000Hz in the better ear
- •The participant is able to start therapy within 6 weeks of the initial evaluation and can be scheduled for 8 sessions (two per visit) in a 6-week time period
- •Agreement by the participant to provide information regarding days missed from work during the previous year and the year following treatment
排除标准
- •Known degenerative medical condition
- •Concurrent ear-nose-throat diagnosis, e.g., acute allergies (but chronic allergies, sinusitis, and laryngopharyngeal reflux disease (LPR) are not exclusion criteria) and vocal fold hemorrhage
- •Degenerative medical conditions that would exclude a participant from participation include, but are not limited to: degenerative neuromuscular disease, malignant process undergoing treatment or with less than 5 years remission, uncontrolled systemic disease (e.g. auto immune disease), or hormonal condition.
结局指标
主要结局
Score on Voice Handicap Index (VHI)
时间窗: one year
次要结局
- Do LMRVT or CBCFT improve conversational voice quality?(one year)
- Do LMRVT or CBCFT reduce the occurrence of laryngeal microsurgery?(one year)
- Does LMRVT contribute to the actual acquisition of "resonant voice" in speech?(one year)
- Do LMRVT or CBCFT improve laryngeal appearance?(one year)
- Do LMRVT or CBCFT reduce the number of workdays lost annually?(one year)
研究者
Kittie Verdolini Abbott
Professor
University of Pittsburgh
研究点 (4)
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