Prenatal Education About Reducing Labor Stress (PEARLS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mindful Meditation for Epidural Catheter Placement

NCT04687085

Anxiety Pain

COMPLETED NA

Study of Affect Induction for Lab Induced Pain in Healthy Undergraduates

NCT05619419

Meditation Pain Mindfulness +2 more

COMPLETED NA

Stress Reduction: A Pilot Study With Adolescents

NCT02629016

Physiological Stress Psychological Stress

COMPLETED NA

Use of Incentives for Stressful Medical Procedures

NCT06254898

Healthy

RECRUITING NA

The Impact of a Continuous Performance Task on the Stress Response

NCT06098352

Stress

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain Tocophobia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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)

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).

Group Type ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes