Estimating the Effective Dose of Music Duration for Anxiety Reduction Prior to Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Anxiety Score
研究概览
简要总结
This is a clinical study that aims to determine the effective dose of music listening duration that is required to reduce anxiety in patients awaiting scheduled cesarean section. It will also compare types of music to accomplish this goal, both of which have been shown effective in prior studies. Methods will involve enrolling and playing music for patients awaiting scheduled C-section, and scoring their anxiety with pre- and post-music questionnaires. Music duration for each subject will be predetermined, and analysis of response will be performed to determine the effective dose 95%, or dose at which 95% of subjects should have a positive response.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Planning on scheduled cesarean section or non-emergent unscheduled cesarean section
- •Able to provide informed consent
- •American Society of Anaesthesiologists (ASA) physical status score of II-III
排除标准
- •Patient refusal
- •Impaired hearing
- •Patient is taking at least one anxiolytic medication daily at baseline
- •No anxiety (a score of 0, on a scale of 0-10, of pre-music exposure anxiety) after consent is given
- •ASA IV or higher
结局指标
主要结局
Anxiety Score
时间窗: 4-8 minutes
Verbally rated anxiety on numeric rating scale (NRS) of 0-10, before and after intervention. A rating of 0 meant the patient had no anxiety, while a rating of 10 meant the patient had the worst anxiety possible. Must have been at least a 1-point decrease between pre- and post-intervention scores to be considered a positive response, larger decrease meant a better outcome.
次要结局
- STAI(4-8 minutes)