A Randomized Controlled Trial of Playing "The Most Relaxing Song in the World" During Labor Epidural Placement and Its Effects on Anxiety and Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean Score of Anxiety Before Epidural Placement
研究概览
简要总结
The objective of the study is to determine if playing the song "Weightless" by Marconi Union during labor epidural placement, decreases laboring parturient anxiety and improves satisfaction with the experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Females ages 18 years and older committed to delivery by the obstetrical team (natural labor or induction of labor)
- •English speaking
- •Able to give informed consent
- •Having an epidural placed
排除标准
- •Patient refusal
- •Intrauterine fetal demise
- •Imminent delivery
- •Existing music use
研究组 & 干预措施
Intervention Group
The song "Weightless" by Marconi Union will be playing during subjects labor epidural placement.
干预措施: Song "Weightless" by Marconi Union (Other)
Non Intervention Group
No song will be played during subjects labor epidural placement.
干预措施: No Song (Other)
结局指标
主要结局
Mean Score of Anxiety Before Epidural Placement
时间窗: Immediately prior to procedure
3 different measures of anxiety prior to the procedure based on the State Trait Anxiety Inventory: 1) Numeric Rating Scale from 0-10 with 0 representing no anxiety and 10 representing worst anxiety possible. 2) Asking patient response to the question "Are you calm" with options scaling from "very much, moderately, somewhat, or not at all". 3) Asking the patient to answer the question "are you relaxed?" with options scaling from "very much, moderately, somewhat, or not at all." "Very much" will be treated as a positive finding and "moderately, somewhat, or not at all" as negative. The short form of the State Trait Anxiety Inventory with these three measures has been shown to be a reliable measure of anxiety. A fourth measure used will be a Visual Analog Scale from 0-100 of overall anxiety with 0 representing no anxiety and 100 representing the worst anxiety possible.
Mean Score of Anxiety After Epidural Placement
时间窗: Immediately after procedure
As soon as the epidural has been placed and appropriate documentation for the procedure is completed, both groups will take the same surveys again.
次要结局
未报告次要终点
研究者
David Gutman
Principal Investigator
Medical University of South Carolina