Preparing Mothers for External Cephalic Version: a Mindfulness-based Intervention for Pregnant Women With a Baby in Breech Presentation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Post-intervention external cephalic version success rate
研究概览
简要总结
The study is a randomized controlled trial examining the effectiveness of a short mindfulness-based intervention on the success rate of external cephalic version in pregnant women with breech presentation. It is hypothesized that this intervention will increase the ECV success rate and decrease the pain experienced after the ECV.
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
- Single (Care Provider)
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
- •Pregnant women (18+y).
- •With a breech presenting fetus undergoing external cephalic version.
- •Dutch/English-speaking or understanding Dutch/English.
排除标准
- 未提供
研究组 & 干预措施
Intervention group
Short mindfulness-based intervention (5 minutes) prior to the external cephalic version
干预措施: Short mindfulness-based intervention (Behavioral)
Control group
Care as usual
结局指标
主要结局
Post-intervention external cephalic version success rate
时间窗: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
The success rate of the external cephalic versions (successful/not successful) will be compared between the intervention and control group.
次要结局
- Post-intervention pain perception(1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version))
- Post-intervention comfort(1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version))
研究者
Simone Kuppens
Principal Investigator
Catharina Ziekenhuis Eindhoven