The Role of Voice Rest on Voice Outcomes Following Phonosurgery: A Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Voice Handicap Index (VHI)-10
研究概览
简要总结
Patients undergoing vocal cord surgery (phonosurgery) are often prescribed voice rest postoperatively. However, no clinical trials have ever been conducted to ascertain the efficacy of using voice rest and its impact on functional voice outcomes. The purpose of this randomized-clinical trial is to determine if the prescription of voice rest has an impact on voice outcomes following phonosurgery.
详细描述
The study will seek to determine if a 7-day period of absolute voice rest alters voice-related quality of life following phonosurgery
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •Unilateral vocal cord lesion
- •Consented for phonosurgery
排除标准
- •Age less than 18 years
- •Bilateral vocal cord lesions
- •Prior vocal cord surgery
研究组 & 干预措施
Control
Patients in the control arm will undergo a graduated prescription of voice use immediately following surgery.
Absolute Voice Rest
Patients in the experimental arm will undergo 7 days of absolute voice rest following surgery.
干预措施: Absolute Voice Rest (Behavioral)
结局指标
主要结局
Voice Handicap Index (VHI)-10
时间窗: 12 weeks post-operative
次要结局
- Frequency perturbation (jitter)(12 weeks post-operative)
- Fundamental frequency(12 weeks post-operative)
- Maximum phonation time(12 weeks post-operative)
- Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale(12 weeks post-operative)
- Amplitude perturbation (shimmer)(12 weeks post-operative)