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Prenatal Education About Reducing Labor Stress (PEARLS) (PEARLS)

Primary Purpose

Labor Pain, Tocophobia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mind in Labor (MIL): Working with Pain in Childbirth

Treatment as usual (TAU)

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring childbirth, mindfulness, fear of labor, labor pain, coping, self-efficacy, childbirth satisfaction, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

The Osher Center for Integrative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mind in Labor (MIL)

Treatment As Usual (TAU)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)

Change in levels of self-reported childbirth self-efficacy and pain catastrophizing

Perceived labor pain

Retrospective self-report of perceived pain in labor

Pain medication use during labor

Type, dose, and frequency of pain medication use during labor and delivery, recorded in medical record.

Childbirth satisfaction

Self-reported satisfaction with experiences of childbirth

Change in Depression

Self-reported depressive mood/symptoms of depression

Secondary Outcome Measures

Perceived stress and parenting stress

Change in and level of self-report of general perceived life stress and parenting-specific stress

Mindfulness and interoceptive body awareness

Change in and level of self-report mindfulness in everyday life and interoceptive body awareness

Positive and negative emotion

Change in and level of self-report of intensity and frequency of positive and negative affect

Anxiety

Change in and level of self-report of trait anxiety, pregnancy-related anxiety, and worry

Full Information

NCT ID

NCT02327559

First Posted

June 23, 2014

Last Updated

May 23, 2017

Sponsor

University of California, San Francisco

Collaborators

Mount Zion Health Fund

1. Study Identification

Unique Protocol Identification Number

NCT02327559

Brief Title

Prenatal Education About Reducing Labor Stress (PEARLS)

Acronym

PEARLS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

Mount Zion Health Fund

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Labor Pain, Tocophobia

Keywords

childbirth, mindfulness, fear of labor, labor pain, coping, self-efficacy, childbirth satisfaction, depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mind in Labor (MIL)

Arm Type

Experimental

Arm Description

Arm Title

Treatment As Usual (TAU)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mind in Labor (MIL): Working with Pain in Childbirth

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Treatment as usual (TAU)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)

Description

Change in levels of self-reported childbirth self-efficacy and pain catastrophizing

Time Frame

Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)

Title

Perceived labor pain

Description

Retrospective self-report of perceived pain in labor

Time Frame

Postpartum (average of 6 weeks post-birth)

Title

Pain medication use during labor

Description

Type, dose, and frequency of pain medication use during labor and delivery, recorded in medical record.

Time Frame

Labor (during childbirth)

Title

Childbirth satisfaction

Description

Self-reported satisfaction with experiences of childbirth

Time Frame

Postpartum (average of 6 weeks post-birth)

Title

Change in Depression

Description

Self-reported depressive mood/symptoms of 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)

Secondary Outcome Measure Information:

Title

Perceived stress and parenting stress

Description

Change in and level of self-report of general perceived life stress and parenting-specific 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)

Title

Mindfulness and interoceptive body awareness

Description

Change in and level of self-report mindfulness in everyday life 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)

Title

Positive and negative emotion

Description

Change in and level of self-report of intensity and frequency of positive and negative affect

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)

Title

Anxiety

Description

Change in and level of self-report of trait anxiety, pregnancy-related anxiety, and worry

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)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Larissa G Duncan, PhD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Osher Center for Integrative Medicine

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34231203

Citation

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.

Results Reference

derived

PubMed Identifier

33059638

Citation

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.

Results Reference

derived

PubMed Identifier

28499376

Citation

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.

Results Reference

derived

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Prenatal Education About Reducing Labor Stress (PEARLS)

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