Prenatal Education About Reducing Labor Stress (PEARLS)

Not Applicable

Completed

• Conditions: Labor Pain; Tocophobia
• Interventions: Behavioral: Treatment as usual (TAU)

• Registration Number: NCT02327559
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2014-02
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-30
• Study Completion: 2015-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment As Usual (TAU)	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).

Primary Outcome Measures

Name	Time	Method
Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)	Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)	Change in levels of self-reported childbirth self-efficacy and pain catastrophizing
Pain medication use during labor	Labor (during childbirth)	Type, dose, and frequency of pain medication use during labor and delivery, recorded in medical record.
Childbirth satisfaction	Postpartum (average of 6 weeks post-birth)	Self-reported satisfaction with experiences of childbirth
Change in Depression	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
Perceived labor pain	Postpartum (average of 6 weeks post-birth)	Retrospective self-report of perceived pain in labor

Secondary Outcome Measures

Name	Time	Method
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)	Change in and level of self-report mindfulness in everyday life and interoceptive body awareness
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)	Change in and level of self-report of general perceived life stress and parenting-specific stress
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)	Change in and level of self-report of intensity and frequency of positive and negative affect
Anxiety	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

Trial Locations

Locations (1)

The Osher Center for Integrative Medicine; 🇺🇸 San Francisco, California, United States