Skip to main content
OpenTrials
Completed

NCT Number: NCT02327559

Prenatal Education About Reducing Labor Stress (PEARLS)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Labor Pain Behavior Behavioral Symptoms Depression Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tocophobia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mind in Labor (MIL): Working with Pain in Childbirth

Behavioral

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.

Treatment as Usual (TAU)

Behavioral

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

  1. 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

  2. Perceived labor pain

    Time frame: Postpartum (average of 6 weeks post-birth)

    Retrospective self-report of perceived pain in labor

  3. 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.

  4. Childbirth satisfaction

    Time frame: Postpartum (average of 6 weeks post-birth)

    Self-reported satisfaction with experiences of childbirth

  5. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Mount Zion Health Fund

Registry information

Official study title

Randomized Controlled Trial of a Mindfulness Intervention for Labor-Related Pain and Fear

Acronym: PEARLS

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Dec 30, 2014
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.