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Labor PainPEARLSNCT02327559

Prenatal Education About Reducing Labor Stress (PEARLS)

A study testing Mind in Labor (MIL): Working with Pain in Childbirth and Treatment as usual (TAU) in people with Labor Pain and Tocophobia, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain, Tocophobia
What is being tested?
Mind in Labor (MIL): Working with Pain in Childbirth and Treatment as usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
Oct 2011to Feb 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Osher Center for Integrative Medicine

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: 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.

Being tested
Mind in Labor (MIL): Working with Pain in Childbirth, Treatment as usual (TAU)
Keywords
childbirth, mindfulness, fear of labor, labor pain, coping, self-efficacy, childbirth satisfaction, depression
Medical subject headings
Labor Pain, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mind in Labor (MIL): Working with Pain in ChildbirthBehavioural

    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)Behavioural

    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).

Study groups in NCT02327559
Study groupRoleWhat they receive
Mind in Labor (MIL)ExperimentalMind 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.
Receives: Behavioral: Mind in Labor (MIL): Working with Pain in Childbirth
Treatment As Usual (TAU)Active comparatorTreatment 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).
Receives: Behavioral: Treatment as usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

  2. Perceived labor pain

    Retrospective self-report of perceived pain in labor

    Measured: Postpartum (average of 6 weeks post-birth)

  3. Pain medication use during labor

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

    Measured: Labor (during childbirth)

  4. Childbirth satisfaction

    Self-reported satisfaction with experiences of childbirth

    Measured: Postpartum (average of 6 weeks post-birth)

  5. Change in Depression

    Self-reported depressive mood/symptoms of depression

    Measured: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)

Secondary outcomes (4)

  1. Perceived stress and parenting stress

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

    Measured: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)

  2. Mindfulness and interoceptive body awareness

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

    Measured: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)

  3. Positive and negative emotion

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

    Measured: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)

  4. Anxiety

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

    Measured: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2014 (estimated)
  2. Study startOct 2011
  3. Primary completionFeb 2014
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02327559
Sponsor's protocol ID
PEARLSMZHF
Acronym
PEARLS
Status last verified
May 2017
First submitted
23 Jun 2014
Last updated
25 May 2017
Results posted
No
Data monitoring committee
No

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.

    PubMed 34231203

  • 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.

    PubMed 33059638

  • 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.

    PubMed 28499376

Questions about this trial

What is this clinical trial studying?

A study testing Mind in Labor (MIL): Working with Pain in Childbirth and Treatment as usual (TAU) in people with Labor Pain and Tocophobia, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fear of labor (childbirth self-efficacy and pain catastrophizing) (time frame: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02327559, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.

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