- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02327559
Prenatal Education About Reducing Labor Stress (PEARLS) (PEARLS)
May 23, 2017 updated by: University of California, San Francisco
Randomized Controlled Trial of a Mindfulness Intervention for Labor-Related Pain and Fear
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- The Osher Center for Integrative Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mind in Labor (MIL)
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.
|
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.
|
Active Comparator: 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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)
Time Frame: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)
|
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
Time Frame: Postpartum (average of 6 weeks post-birth)
|
Retrospective self-report of perceived pain in labor
|
Postpartum (average of 6 weeks post-birth)
|
Pain medication use during labor
Time Frame: Labor (during childbirth)
|
Type, dose, and frequency of pain medication use during labor and delivery, recorded in medical record.
|
Labor (during childbirth)
|
Childbirth satisfaction
Time Frame: Postpartum (average of 6 weeks post-birth)
|
Self-reported satisfaction with experiences of childbirth
|
Postpartum (average of 6 weeks post-birth)
|
Change in Depression
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)
|
Anxiety
Time Frame: 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
|
Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Larissa G Duncan, PhD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
June 23, 2014
First Submitted That Met QC Criteria
December 23, 2014
First Posted (Estimate)
December 30, 2014
Study Record Updates
Last Update Posted (Actual)
May 25, 2017
Last Update Submitted That Met QC Criteria
May 23, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEARLSMZHF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Labor Pain
-
Cukurova UniversityRecruitingLabor Pain, Labor Perception, Hormone Levels and Childbirth ComfortTurkey
-
Soovu Labs Inc.Virginia Mason Hospital/Medical CenterNot yet recruiting
-
Bogomolets National Medical UniversityCompleted
-
Martin-Luther-Universität Halle-WittenbergRecruiting
-
Maimonides Medical CenterTerminated
-
Aretaieio HospitalRecruitingLabor Pain | Pain, Labor | EpiduralGreece
-
Mashhad University of Medical SciencesTerminatedDecrease Labor Pain
-
Amasya UniversityAtaturk UniversityNot yet recruitingSatisfaction, Patient | Pain, Labor
-
University Medical Centre LjubljanaCompletedLabor Pain | Labor; Prolonged, First Stage | Labor; Prolonged, Second StageSlovenia
Clinical Trials on Mind in Labor (MIL): Working with Pain in Childbirth
-
University of Texas at AustinNational Institute of Nursing Research (NINR); Fordham UniversityCompleted
-
Gaziosmanpasa Research and Education HospitalCompletedRotator Cuff Tear | Shoulder Impingement Syndrome | Shoulder Pain | Shoulder TendinitisTurkey
-
Sisters of Mercy University HospitalBioGaia ABUnknownLactobacillus Reuteri in Treatment of Functional Abdominal Pain and Chronic Constipation in ChildrenAbdominal Pain | Constipation - FunctionalCroatia
-
Charles University, Czech RepublicNot yet recruiting
-
VA Office of Research and DevelopmentCompleted
-
Philipps University Marburg Medical CenterCompleted
-
Namik Kemal UniversityCompletedEnd Stage Renal DiseaseTurkey
-
Universitaire Ziekenhuizen KU LeuvenFund for Scientific Research, Flanders, BelgiumCompletedCancer Pain | Cancer SurvivorsBelgium
-
Vrije Universiteit BrusselCompletedLow Back Pain | Central Sensitisation | Sensory Profiles | Nociplastic PainBelgium
-
Universidad Politecnica de MadridCompletedChronic Pain | Athletic Injuries | Physical DisabilitySpain