Randomized Controlled Trial of a Mindfulness Intervention for Labor-Related Pain and Fear
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Labor Pain
- Sponsor
- University of California, San Francisco
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)
Time Frame: 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
Time Frame: Labor (during childbirth)
Type, dose, and frequency of pain medication use during labor and delivery, recorded in medical record.
Childbirth satisfaction
Time Frame: Postpartum (average of 6 weeks post-birth)
Self-reported satisfaction with experiences of childbirth
Change in Depression
Time Frame: 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
Time Frame: Postpartum (average of 6 weeks post-birth)
Retrospective self-report of perceived pain in labor
Secondary Outcomes
- 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))