Randomized Controlled Trial of a Mindfulness Intervention for Labor-Related Pain and Fear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)
研究概览
简要总结
The purpose of this small randomized controlled trial (RCT) is to compare the impact of a brief (16 hour) 3rd trimester mindfulness-based childbirth education program, "Mind in Labor (MIL): Working with Pain in Childbirth," with a standard care/"treatment as usual" (TAU) active control condition of standard hospital- and community-based childbirth education. The MIL group is expected to demonstrate a reduction in fear of labor (less pain catastrophizing and greater childbirth self-efficacy), less perceived pain in labor, less use of pain medication in labor, greater birth satisfaction, and better prenatal and postpartum psychological adjustment compared to the TAU group.
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
- Double (Participant, Investigator)
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
- •Age 18 or over
- •No prior full-term pregnancy or live birth prior to the current pregnancy
- •In 3rd trimester of healthy, singleton pregnancy
- •Willingness to be randomized
- •Able to read, write, and understand spoken English
- •Planned hospital birth in the San Francisco Bay Area
排除标准
- •Current or prior formal meditation experience
- •Formal yoga practice prior to pregnancy (brief prenatal yoga practice will not lead to exclusion)
- •Participation in other mind/body childbirth preparation course (e.g., with hypnosis focus)
- •Planned elective Cesarean birth
- •Planned homebirth or other non-hospital birth setting
研究组 & 干预措施
Mind in Labor (MIL)
Mind in Labor: Working with Pain in Childbirth (MIL) is a 16-hour mindfulness-based childbirth education course. It is an abbreviated weekend workshop form of the 9-week Mindfulness-Based Childbirth and Parenting (MBCP) education program, which is a tailored form of Mindfulness-Based Stress Reduction.
干预措施: Mind in Labor (MIL): Working with Pain in Childbirth (Behavioral)
Treatment As Usual (TAU)
Treatment As Usual (TAU) refers to standard hospital- and community-based childbirth preparation courses (high quality childbirth education that excludes a mindfulness or mind/body stress reduction focus).
干预措施: Treatment as usual (TAU) (Behavioral)
结局指标
主要结局
Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)
时间窗: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)
Change in levels of self-reported childbirth self-efficacy and pain catastrophizing
Pain medication use during labor
时间窗: Labor (during childbirth)
Type, dose, and frequency of pain medication use during labor and delivery, recorded in medical record.
Childbirth satisfaction
时间窗: Postpartum (average of 6 weeks post-birth)
Self-reported satisfaction with experiences of childbirth
Change in Depression
时间窗: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)
Self-reported depressive mood/symptoms of depression
Perceived labor pain
时间窗: Postpartum (average of 6 weeks post-birth)
Retrospective self-report of perceived pain in labor
次要结局
- Mindfulness and interoceptive body awareness(Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth))
- Perceived stress and parenting stress(Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth))
- Positive and negative emotion(Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth))
- Anxiety(Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth))