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Prenatal Education About Reducing Labor Stress (PEARLS)

NCT02327559 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-05-25

No results posted yet for this study

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

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).

Sponsors & Collaborators

Principal Investigators

  • Larissa G Duncan, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02327559 on ClinicalTrials.gov