Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-27 @ 8:00 AM
Study NCT ID:
NCT02327559
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2014-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Education About Reducing Labor Stress (PEARLS)
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Randomized Controlled Trial of a Mindfulness Intervention for Labor-Related Pain and Fear
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEARLS
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: