Perioperative Music for Patients Undergoing Scheduled Cesarean Delivery: Impact on Satisfaction, Anxiety, and Hemodynamic Response to Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- maternal anxiety level, VAS
研究概览
简要总结
The aim of this study is to evaluate the effect of perioperative music on maternal anxiety, hemodynamic response to spinal anesthesia, postoperative pain medication requirement, and overall maternal satisfaction.
Investigators hypothesize that women exposed to perioperative music will have greater overall satisfaction with the delivery experience. Investigators also hypothesize that perioperative music will lower anxiety levels of women having a scheduled cesarean delivery, result in a less profound degree of spinal-induced hypotension prior to cesarean delivery, and result in a lower requirement of analgesics postpartum.
详细描述
Several studies have demonstrated that preoperative anxiety has been associated with more profound hypotension after spinal anesthesia for cesarean delivery. Music has been shown to have a positive impact on hemodynamic response and patient satisfaction.
To investigators knowledge, however, no studies have evaluated the effects of music during the perioperative period for cesarean delivery on patient satisfaction and hemodynamic responses.
The study will be conducted as a randomized unblended controlled trial with three study arms: control (no music), intervention - Pandora® (patient selected music), and intervention - Mozart (pre-selected relaxing music). Eligibility criteria include pregnant women, 18 years or older, scheduled for elective cesarean delivery under spinal anesthesia. Exclusion criteria include absolute contraindications of neuraxial anesthesia including patient refusal, uncorrected coagulopathy, infection at the skin site of epidural placement, increased intracranial pressure, or untreated hemodynamic instability. Patients in active labor, with impaired hearing, or who do not want to participate in the study will also be excluded. All subjects will be recruited from women admitted for scheduled cesarean delivery at Brigham and Women's Hospital. Investigators anticipate enrolling 150 patients, with 50 patients in each arm of the study.
Participation begins at the time of consultation on the day of surgery, and ends after the post-anesthesia check on postoperative day 1. After recruitment and consent, patients will be randomized using a computer-generated randomization scheme will be used to allocate patients to one of the arms of the study.
The three arms of the study are as follows:
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
- •pregnant women
- •8 years or older
- •scheduled for elective cesarean delivery under spinal anesthesia.
排除标准
- •absolute contraindications of neuraxial anesthesia including patient refusal
- •uncorrected coagulopathy
- •infection at the skin site of epidural placement
- •increased intracranial pressure, or untreated hemodynamic instability.
- •Patients in active labor, with impaired hearing, or who do not want to participate in the study will also be excluded.
研究组 & 干预措施
Control
baseline hemodynamics and anxiety screen; no music
Pandora Music
A study investigator will create a station in the Pandora® music application based on the patient's preferred music genre or artist.
干预措施: Pandora Music (Other)
Mozart Music
A study investigator will turn on a playlist of pre-selected Mozart music.
干预措施: Mozart Music (Other)
结局指标
主要结局
maternal anxiety level, VAS
时间窗: 30 minutes after surgery
assessed by VAS questionnaire
maternal anxiety level, VAS
时间窗: prior to surgery
assessed by VAS questionnaire
次要结局
- Vasopressor requirement, phenylephrine(within 30 minutes of spinal placement)
- Change in maternal blood pressure after spinal anesthesia induction , compared to baseline blood pressure(within 30 minutes of spinal placement)
- Vasopressor requirement, ephedrine(within 30 minutes of spinal placement)
- maternal anxiety level, STAI(30 minutes after surgery)
- Overall patient satisfaction, questionnaire(postoperative day 1)
- Overall patient satisfaction, pain control(postoperative day 1)
- maternal anxiety level, STAI(prior to surgery)
- Overall patient satisfaction, questionnaire(prior to surgery)
- Overall patient satisfaction, questionnaire(30 minutes after surgery)
- Overall patient satisfaction, pain control(prior to surgery)
- Overall patient satisfaction, pain control(30 minutes after surgery)
研究者
Michaela Kristina Farber, MD
Principal Investigator
Brigham and Women's Hospital