Prenatal Education About Reducing Labor Stress (PEARLS)

NCT02327559 | Completed

• 1 other identifier: PEARLSMZHF
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor Pain; Tocophobia

Keywords

childbirth; mindfulness; fear of labor; labor pain; coping; self-efficacy; childbirth satisfaction; depression

Outcome Measures

Primary Outcomes (5)

• Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)

  Change in levels of self-reported childbirth self-efficacy and pain catastrophizing

  Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)

• Perceived labor pain

  Retrospective self-report of perceived pain in labor

  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.

  Labor (during childbirth)

• Childbirth satisfaction

  Self-reported satisfaction with experiences of childbirth

  Postpartum (average of 6 weeks post-birth)

• Change in Depression

  Self-reported depressive mood/symptoms of depression

  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 (4)

• Perceived stress and parenting stress

  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

  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

  Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)

• Anxiety

  Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)

Study Arms (2)

Mind in Labor (MIL)

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.

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

Treatment As Usual (TAU)

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).

Behavioral: Treatment as usual (TAU)

Interventions

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.

Mind in Labor (MIL)

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).

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current or prior formal meditation experience
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Mount Zion Health Fund: collaborator

Study Sites (1)

The Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Location

Related Publications (3)

• O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.

  PMID: 34231203 DERIVED

• Sbrilli MD, Duncan LG, Laurent HK. Effects of prenatal mindfulness-based childbirth education on child-bearers' trajectories of distress: a randomized control trial. BMC Pregnancy Childbirth. 2020 Oct 15;20(1):623. doi: 10.1186/s12884-020-03318-8.

  PMID: 33059638 DERIVED

• Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3.

  PMID: 28499376 DERIVED

MeSH Terms

Conditions

Labor Pain; Depression

Interventions

Parturition; Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Larissa G Duncan, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: December 30, 2014
• Study Start: October 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2015
• Last Updated: May 25, 2017

Record last verified: 2017-05

Locations

US (1)