Prenatal Education About Reducing Labor Stress (PEARLS)

Study Overview
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Brief Summary
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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.

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

Conditions
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Labor Pain, Tocophobia

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind in Labor (MIL)<br>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<br>* 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.<br>|
| Active Comparator: Treatment As Usual (TAU)<br>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)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress and parenting stress | Change in and level of self-report of general perceived life stress and parenting-specific 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 | Change in and level of self-report mindfulness in everyday life 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 | Change in and level of self-report of intensity and frequency of positive and negative affect | Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth) | 
| Anxiety | Change in and level of self-report of trait anxiety, pregnancy-related anxiety, and worry | Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childbirth, mindfulness, fear of labor, labor pain, coping, self-efficacy, childbirth satisfaction, depression