A Randomized Controlled Trial of Music vs. No Music During Cesarean Delivery on Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Patient Satisfaction
研究概览
简要总结
Several studies have demonstrated that music can improve various outcomes during labor and delivery. However, many of these studies didn't measure satisfaction rate accurately. This study aim to assess patient satisfaction in the setting of music or no music during the cesarean delivery. The study will be conducted in the labor and delivery unit and the expected number to enroll and complete the study is 22.
详细描述
Background:
Several studies have demonstrated that music can improve various outcomes during labor and delivery. In particular, patient satisfaction is often measured on a simple VAS scale, where 0 is no satisfaction and 10 is the highest satisfaction. However, patient satisfaction is a complex parameter to measure, and may be affected by a number of different factors. This study will be performed on the labor and delivery unit to assess patient satisfaction with a validated, reliable, 22-question survey in the setting of music or no music during the cesarean delivery.
Although "music" is an all-encompassing term that describes sound with different pitches and rhythms that comes together as a harmonious whole, not all music is the same. Using "music" for therapeutic purposes would be the equivalent of using "antibiotics" to cure an infection; it is too general of a term, and unlikely that such a general use of music would show a valid therapeutic benefit. However, a study demonstrated that specific selections of Mozart piano sonatas, which have a specific rhythm and mode, improve patient anxiety through a biochemical mechanism (changing the plasma levels of IL-6 and epinephrine). Therefore, in this study, the term "music" will specifically means the same Mozart sonatas as described in the prior study.
Objectives:
The objective of this study is to determine the effect of music on patient satisfaction and anxiety during cesarean delivery.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18-50 years old
- •Scheduled for elective cesarean delivery
- •Nulliparity
- •Singleton pregnancy
- •Full term fetus (≥37.0 weeks gestational age)
- •Healthy fetus (no known congenital diseases at the time of surgery)
- •Requesting neuraxial anesthesia for the procedure
- •Able to provide informed consent
排除标准
- •Patient refusal
- •Prior history of extensive abdominal surgery
- •Active labor
- •Contraindication to neuraxial anesthesia
- •Uncorrected coagulopathy
- •Infection at the skin site of epidural placement
- •Increased intracranial pressure
- •Untreated hemodynamic instability
- •Known hypersensitivity to local anesthetics (a.k.a. amide or ester allergy)
- •Patients with impaired hearing
- •Patient on anti-anxiolytic medication
结局指标
主要结局
Patient Satisfaction
时间窗: 1 Day
This outcome will be measured using Morgan's "Maternal Satisfaction Scale for Cesarean Section" (MSSCS). It is a 22-item questionnaire, each item have a Likert scale from 1-7 (1 =strongly disagree, 7=strongly agree), yielding a composite (total) score ranging 22-154, representing lowest to highest satisfaction. The questionnaire will be given to participants on post-operative day one during the hours of 8am-1pm.
次要结局
- Patient Anxiety(Perioperatively)
- Hemodynamic Parameter (Mean Arterial Pressure, MAP)(post procedure)