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临床试验/NCT06539754
NCT06539754已完成不适用

Patient Satisfaction of the Environment During Cesarean Delivery

Geisinger Clinic2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2024年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Participant satisfaction

研究概览

简要总结

The goal of this interventional study is to determine whether the option to listen to music during cesarean delivery increases the participants satisfaction. Participants and their support person will be asked to fill out a short survey and mark their satisfaction on a visual analog scale. Vital signs will be recorded during their procedure.

详细描述

Currently, our institution does not routinely offer music during cesarean delivery. The goal of this study would be to determine whether the option to listen to music improves patient satisfaction. Also, the study would examine support person satisfaction and changes in maternal vital signs from prior to entering the operating room as compared to prior to exiting the operating room in a sample of patients. If positive satisfaction results are noted in those randomized to the music arm, this would be a low-cost intervention that providers could utilize to increase patient satisfaction during surgery.

This will be a prospective randomized controlled trial to determine whether the option of music being played in the operating room can impact the experience for the patient. Subjects will be randomized via central computer-generated randomization 1:1 to either have music played during their procedure or no music played during their procedure. A per protocol analysis will be performed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will be randomized in 1:1 stratification to receive music during their procedure or not. Participants will not be aware of the intervention. If a patient is randomized into music, they will be offered headphones to listen to during their procedure.

入排标准

性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy
  • Second or third cesarean delivery
  • Scheduled cesarean delivery at Geisinger Medical Center
  • Able and willing to provide consent
  • English speaking
  • Greater than or equal to 37 weeks' gestation

排除标准

  • Fetal anomaly
  • Multifetal gestation
  • Hearing loss requiring a sign interpreter or hearing aids
  • Planned general anesthesia
  • Intrauterine fetal demise
  • Participants that present in labor or require urgent/emergent cesarean delivery

结局指标

主要结局

Participant satisfaction

时间窗: This is collected during the study duration, on average 6 hours.

Visual analog scales from 0-10 (0=extremely unsatisfied, 10=extremely satisfied) will be collected by the patient marking on the line prior to the procedure and during skin closure.

次要结局

  • Support person satisfaction(This is collected through the duration of the study, on average 6 hours,)
  • Heart rate(This will be collected during the study duration, an average 6 hours.)
  • Music and satisfaction(This is collected during the study duration, on average 6 hours.)
  • Blood pressure(This will be collected during the study duration, an average 6 hours.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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