Labor Pain, Tocophobia
Conditions
Keywords
childbirth, mindfulness, fear of labor, labor pain, coping, self-efficacy, childbirth satisfaction, depression
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.
Interventions
BEHAVIORALMind in Labor (MIL): Working with Pain in Childbirth
The Mind in Labor (MIL) mindfulness intervention for pregnant women and their partners integrates mindfulness strategies for coping with labor pain and fear and formal mindfulness meditation with traditional childbirth education. The MIL intervention is held over 3 consecutive weekend days (Friday - Sunday) for a total of 16 hours of mindfulness skills training for childbirth preparation and labor pain management. Mindfulness strategies for coping with labor-related pain and fear are taught in an interactive, experiential format, with periods of didactic instruction.
BEHAVIORALTreatment as usual (TAU)
The treatment as usual TAU active comparison condition includes participation in a standard care childbirth education course, chosen by participants in the TAU arm from a pre-approved list of hospital- and community-based childbirth education courses comparable in length and quality to MIL, but without any mindfulness meditation, mindful movement/yoga, or other core mind/body component (e.g., hypnosis).
Sponsors
Mount Zion Health Fund
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression | 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 |
| Change in Fear of labor (childbirth self-efficacy and pain catastrophizing) | Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth) | Change in levels of self-reported childbirth self-efficacy and pain catastrophizing |
| Perceived labor pain | Postpartum (average of 6 weeks post-birth) | Retrospective self-report of perceived pain in labor |
| Pain medication use during labor | Labor (during childbirth) | Type, dose, and frequency of pain medication use during labor and delivery, recorded in medical record. |
| Childbirth satisfaction | Postpartum (average of 6 weeks post-birth) | Self-reported satisfaction with experiences of childbirth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Change in and level of self-report mindfulness in everyday life and interoceptive body awareness |
| 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) | Change in and level of self-report of intensity and frequency of positive and negative affect |
| Anxiety | Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth) | Change in and level of self-report of trait anxiety, pregnancy-related anxiety, and worry |
| 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) | Change in and level of self-report of general perceived life stress and parenting-specific stress |
Countries
United States
Outcome results
None listed