Prenatal Education About Reducing Labor Stress (PEARLS)

Overview

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.

Full Title of Study: “Randomized Controlled Trial of a Mindfulness Intervention for Labor-Related Pain and Fear”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2014

Interventions

  • Behavioral: 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.
  • Behavioral: 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).

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Perceived labor pain
    • Time Frame: Postpartum (average of 6 weeks post-birth)
    • Retrospective self-report of perceived pain in labor
  • 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

Secondary Measures

  • 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)
    • Change in and level of self-report of general perceived life stress and parenting-specific stress
  • 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)
    • Change in and level of self-report mindfulness in everyday life and interoceptive body awareness
  • 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)
    • Change in and level of self-report of intensity and frequency of positive and negative affect
  • 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)
    • Change in and level of self-report of trait anxiety, pregnancy-related anxiety, and worry

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Collaborator
    • Mount Zion Health Fund
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Larissa G Duncan, PhD, Principal Investigator, University of California, San Francisco

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