Prenatal Education About Reducing Labor Stress (PEARLS)

Labor Pain Clinical Trial

— PEARLS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327559
• Other study ID #: PEARLSMZHF
• Status: Completed
• Phase: N/A
• First received: June 23, 2014
• Last updated: May 23, 2017
• Start date: October 2011
• Est. completion date: February 2015

Study information

• Verified date: May 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Tocophobia

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	The Osher Center for Integrative Medicine	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Mount Zion Health Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Perceived labor pain	Retrospective self-report of perceived pain in labor	Postpartum (average of 6 weeks post-birth)
Primary	Pain medication use during labor	Type, dose, and frequency of pain medication use during labor and delivery, recorded in medical record.	Labor (during childbirth)
Primary	Childbirth satisfaction	Self-reported satisfaction with experiences of childbirth	Postpartum (average of 6 weeks post-birth)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)