An interventional study of Mind in Labor (MIL): Working with Pain in Childbirth and Treatment as usual (TAU) in Labor Pain and Tocophobia, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-25.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 33 is below the median of 100 across 326 interventional studies indexed under Labor Pain.
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Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Mind in Labor (MIL): Working with Pain in Childbirth
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).
Behavioral: Treatment as usual (TAU)
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.
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).
Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)
Change in levels of self-reported childbirth self-efficacy and pain catastrophizing
Time frame: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)
Perceived labor pain
Retrospective self-report of perceived pain in labor
Time frame: Postpartum (average of 6 weeks post-birth)
Pain medication use during labor
Type, dose, and frequency of pain medication use during labor and delivery, recorded in medical record.
Time frame: Labor (during childbirth)
Childbirth satisfaction
Self-reported satisfaction with experiences of childbirth
Time frame: Postpartum (average of 6 weeks post-birth)
Change in Depression
Self-reported depressive mood/symptoms of 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)
Perceived stress and parenting stress
Change in and level of self-report of general perceived life stress and parenting-specific stress
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)
Mindfulness and interoceptive body awareness
Change in and level of self-report mindfulness in everyday life and interoceptive body awareness
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)
Positive and negative emotion
Change in and level of self-report of intensity and frequency of positive and negative affect
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)
Anxiety
Change in and level of self-report of trait anxiety, pregnancy-related anxiety, and worry
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)
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco