Clinical trial NCT02327559: Prenatal Education About Reducing Labor Stress (PEARLS)
Official title: Randomized Controlled Trial of a Mindfulness Intervention for Labor-Related Pain and Fear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Tocophobia
Keywords: childbirth
mindfulness
fear of labor
labor pain
coping
self-efficacy
childbirth satisfaction
depression
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Mount Zion Health Fund
First posted: 2014-12-30
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Fear of labor (childbirth self-efficacy and pain catastrophizing)
timeFrame: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)
measure: Perceived labor pain
timeFrame: Postpartum (average of 6 weeks post-birth)
measure: Pain medication use during labor
timeFrame: Labor (during childbirth)
measure: Childbirth satisfaction
timeFrame: Postpartum (average of 6 weeks post-birth)
measure: Change in Depression
timeFrame: 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:
measure: Perceived stress and parenting stress
timeFrame: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)
measure: Mindfulness and interoceptive body awareness
timeFrame: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)
measure: Positive and negative emotion
timeFrame: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)
measure: Anxiety
timeFrame: Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: The Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Larissa G Duncan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.