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Prenatal Education About Reducing Labor Stress (PEARLS) (PEARLS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02327559
First Posted: December 30, 2014
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mount Zion Health Fund
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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.

Condition Intervention
Labor Pain Tocophobia Behavioral: Mind in Labor (MIL): Working with Pain in Childbirth Behavioral: Treatment as usual (TAU)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of a Mindfulness Intervention for Labor-Related Pain and Fear

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome 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 Outcome 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


Enrollment: 33
Study Start Date: October 2011
Study Completion Date: February 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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).
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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327559


Locations
United States, California
The Osher Center for Integrative Medicine
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Mount Zion Health Fund
Investigators
Principal Investigator: Larissa G Duncan, PhD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02327559     History of Changes
Other Study ID Numbers: PEARLSMZHF
First Submitted: June 23, 2014
First Posted: December 30, 2014
Last Update Posted: May 25, 2017
Last Verified: May 2017

Keywords provided by University of California, San Francisco:
childbirth
mindfulness
fear of labor
labor pain
coping
self-efficacy
childbirth satisfaction
depression

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms