Overview

This trial is active, not recruiting.

Conditions labor pain, tocophobia
Treatments mind in labor (mil): working with pain in childbirth, treatment as usual (tau)
Sponsor University of California, San Francisco
Collaborator Mount Zion Health Fund
Start date October 2011
End date February 2014
Trial size 33 participants
Trial identifier NCT02327559, PEARLSMZHF

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
mind 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.
(Active Comparator)
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).
treatment 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).

Primary Outcomes

Measure
Fear of labor (childbirth self-efficacy and pain catastrophizing)
time frame: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)
Perceived labor pain
time frame: Postpartum (average of 6 weeks post-birth)
Pain medication use during labor
time frame: Labor (during childbirth)
Childbirth satisfaction
time frame: Postpartum (average of 6 weeks post-birth)
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)

Secondary Outcomes

Measure
Perceived stress and parenting 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
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
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
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)

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Randomized Controlled Trial of a Mindfulness Intervention for Labor-Related Pain and Fear
Principal investigator Larissa G Duncan, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.