Mindfulness-Based Childbirth and Parenting Education on Pregnant Women
The Efficacy of a Mindfulness-Based Childbirth and Parenting Education on Pregnant Women's Childbirth Self-efficacy, Psychological Health and Maternal Outcomes: A Randomized Controlled Trial
1 other identifier
interventional
104
0 countries
N/A
Brief Summary
The purpose of this study is to explore the differences between stress, depression, childbirth self-efficacy, mindfulness and postnatal maternal outcomes in pregnant women with Mindfulness-Based Childbirth and Parenting education program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2016
CompletedFirst Submitted
Initial submission to the registry
May 27, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedJune 14, 2017
June 1, 2017
1.8 years
May 27, 2017
June 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
change of prenatal and postnatal stress
Self reported the perception of stress change from baseline to 6 months after childbirth using The Perceived Stress Scale
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Secondary Outcomes (4)
postpartum medical records
After the childbirth within 24 hours will be collected
change of symptoms with depression and anxiety
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
change of the childbirth self-efficacy
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
change of mindfulness
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Study Arms (2)
MBCP education
EXPERIMENTALThe intervention includes 3-hour classes per week during the duration of eight weeks and a 7- hour silent meditation practice as well.
Hospital-based antenatal education
PLACEBO COMPARATORHospital-based antenatal education program will be held 2 hrs once a month for 2 months.
Interventions
MBCP education involves mindfulness breathing and other skills with mindfulness meditations.
Hospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum.
Eligibility Criteria
You may qualify if:
- Subjects were pregnant from 13th to 28th weeks gestation with a singleton pregnancy
- Subjects were at the age over 20
- Could speak and read Chinese fluently
- Willing and be able to attend the education program
- Determined to have a vaginal birth
You may not qualify if:
- Taking medication for diagnosing mental illness
- With complicated or high-risk pregnancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Pan WL, Chang CW, Chen SM, Gau ML. Assessing the effectiveness of mindfulness-based programs on mental health during pregnancy and early motherhood - a randomized control trial. BMC Pregnancy Childbirth. 2019 Oct 10;19(1):346. doi: 10.1186/s12884-019-2503-4.
PMID: 31601170DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wan-Lin Pan, MD
National Taipei University of Nursing and Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nursing department
Study Record Dates
First Submitted
May 27, 2017
First Posted
June 14, 2017
Study Start
February 3, 2016
Primary Completion
December 2, 2017
Study Completion
February 28, 2018
Last Updated
June 14, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share