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临床试验/NCT04214431
NCT04214431已完成不适用

Reducing Fear of Childbirth Among Pregnant Women: Women's Lived Experience, Predictors, and Effects of Mindfulness-based Childbirth Education

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 404 人开始时间: 2015年12月7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
404
试验地点
1
主要终点
Fear of childbirth

研究概览

简要总结

Pregnant women often experience fear of childbirth or anxiety toward the labor pain or uncertainties associated with labor process. To develop and evaluate the efficacy of childbirth educational interventions on reduction of fear or anxiety is an important issue in maternal health care.

详细描述

Fear of childbirth is a common clinical problem among perinatal women and link to adverse health effects on mother's and offspring's well-being. Recently, reducing the childbirth fear becomes a highly important maternity care issues as a result of the fact that the birth rate has been declining rapidly as well as Cesarean rate increased steadily. However, the studies on fear of childbirth among perinatal population in Taiwan were limited. In this proposal the investigators plan to conduct a randomized controlled study examining the effects of mindfulness-based childbirth education. In the randomized controlled study, women will be recruited and randomized into the experiment group (receiving mindfulness-based childbirth education and traditional childbirth education),or will be allocated in the control group receiving traditional childbirth education. Intention-to-treat analysis as well as mixed regression modeling will be used to estimate the effectiveness of the interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • aged of 20 years or greater;
  • 12-25 week of gestation, Singleton pregnancy;
  • able to communicate with Mandarin or Taiwanese;
  • High levels of fear of Childbirth (greater 9 or above on Numeric Rating Scale).

排除标准

  • Current having psychological diseases or substance abuse, unable to follow the mindfulness-based childbirth education;
  • unable to attend every class or each assessment;
  • received any cognitive training in past one year.

结局指标

主要结局

Fear of childbirth

时间窗: postpartum 1 week

Fear of childbirth measure by the Wijma Delivery Expectancy/ Experience Questionnaires, W-DEQ, with total score ranging 0-165. The higher score indicated the higher level of childbirth fear.

次要结局

  • Anxiety(postpartum 1 week)
  • Mindfulness(postpartum 1 week)
  • Depression(postpartum 1 week)
  • Birth outcomes(postpartum 1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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