Effects of a Brief Mindful Meditation Intervention on Patient Anxiety and Satisfaction for Labor Epidural Catheter Placement: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Anxiety level after epidural catheter placement
研究概览
简要总结
Given the high prevalence of neuraxial analgesia use during labor and the anxiety associated with these procedures, a method to decrease this anxiety could benefit millions of laboring women each year. Mindfulness practice has been used by many groups to decrease anxiety during pregnancy with optimistic results. However, there has been no major study evaluating the role of mindfulness interventions on anxiety associated with neuraxial placement. The purpose of our study is to address this gap in knowledge.
详细描述
The primary objective of this study is to evaluate the effects of a brief mindful meditation intervention on anxiety and satisfaction regarding epidural catheter placement for laboring parturients.The investigators hypothesize that a brief mindful meditation intervention, consisting of a 10 minute auditory instructional practice, implemented before epidural catheter placement will:
- Decrease anxiety
- Increase satisfaction
compared to a neutral 10 minute auditory recording control, in participants undergoing labor epidural catheter placement.
The secondary objective of this study is to evaluate whether anesthesia providers experience a difference in satisfaction with labor epidural catheter placement in participants who listen to a brief mindful meditation intervention prior to epidural catheter placement. The investigators hypothesize that anesthesia providers placing labor epidural catheters in patients who listen to a brief mindful meditation intervention prior to labor epidural catheter placement will:
- Experience an increase in satisfaction with labor epidural catheter placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients are eligible for enrollment if they are greater than 18 years of age, admitted for vaginal delivery, anticipating epidural analgesia, and report a numerical pain scale rating of 3 or less at the time of enrollment.
排除标准
- •Do not speak English or admitted for cesarean delivery will be excluded from the study
结局指标
主要结局
Anxiety level after epidural catheter placement
时间窗: Measure 1 time, 10 minutes after epidural catheter placement
Level of anxiety on a numerical rating scale
Pain level after epidural catheter placement
时间窗: Measure 1 time, 10 minutes after epidural catheter placement
Level of pain on a numerical rating scale
次要结局
- Provider satisfaction level after epidural catheter placement(Measure 1 time, 10 minutes after epidural catheter placement)
研究者
Dominique Arce
Instructor in Anesthesia, Harvard Medical School
Brigham and Women's Hospital