Mindfulness-Based Childbirth and Parenting Education on Pregnant Women
Primary Purpose
Stress, Psychological, Pregnancy Related
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MBCP education
Hospital-based antenatal education
Sponsored by
About this trial
This is an interventional prevention trial for Stress, Psychological
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Taking medication for diagnosing mental illness
- With complicated or high-risk pregnancies
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MBCP education
Hospital-based antenatal education
Arm Description
The 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 program will be held 2 hrs once a month for 2 months.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
postpartum medical records
This instrument was to explore whether recording of pregnancy outcome in medical records
change of symptoms with depression and anxiety
Self reported the symptoms with depression and anxiety change from baseline to 6 months after childbirth using the Edinburgh Postnatal Depression Scale
change of the childbirth self-efficacy
Self reported the childbirth self-efficacy change from baseline to 6 months after childbirth using the Childbirth Self-Efficacy Inventory
change of mindfulness
Self reported the mindfulness change from baseline to 6 months after childbirth using Five Factor Mindfulness Questionnaire
Full Information
NCT ID
NCT03185910
First Posted
May 27, 2017
Last Updated
June 10, 2017
Sponsor
National Taipei University of Nursing and Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03185910
Brief Title
Mindfulness-Based Childbirth and Parenting Education on Pregnant Women
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 3, 2016 (Actual)
Primary Completion Date
December 2, 2017 (Anticipated)
Study Completion Date
February 28, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Being a mother is a huge change for women, and she will undergo a high degree of change and a strong threat in this transformation process. The purpose of this study is to explore the efficacy of a Mindfulness-Based Childbirth and Parenting(MBCP) Education Program on prenatal stress, depression, mindfulness, childbirth self-efficacy, and postnatal maternal outcomes.
Randomized Controlled Trial comparing two education programs with health and singleton pregnant women is run by the Random Allocation Software (Saghaei, 2004). Use the G-Power 3.1.9 windows: repeated measures and between factors among two groups to calculate the number of samples, and setting the power = .8, α = .05, effect size = .25. The estimated number of samples may be lost 20%, total 104 samples ( 52 samples in each group).
The protocol for the study used MBCP education, this program helps participants practice in the present moment, so that they may develop more confidence and well-being during pregnancy. The MBCP course is held for 3 hrs once a week for 8 weeks. They also had the home practice of 30 minutes a day with a DVD for the experimental group. The control group attending a hospital-based antenatal education program for 2 hrs once a month for 2 months from hospital staff nurses in all aspects of pregnancy, childbirth and postpartum. This study uses a standard verbal script to the eligible participants who were volunteers of pregnant women in the waiting room of metropolitan hospital in Taiwan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Pregnancy Related
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBCP education
Arm Type
Experimental
Arm Description
The intervention includes 3-hour classes per week during the duration of eight weeks and a 7- hour silent meditation practice as well.
Arm Title
Hospital-based antenatal education
Arm Type
Placebo Comparator
Arm Description
Hospital-based antenatal education program will be held 2 hrs once a month for 2 months.
Intervention Type
Behavioral
Intervention Name(s)
MBCP education
Intervention Description
MBCP education involves mindfulness breathing and other skills with mindfulness meditations.
Intervention Type
Behavioral
Intervention Name(s)
Hospital-based antenatal education
Intervention Description
Hospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum.
Primary Outcome Measure Information:
Title
change of prenatal and postnatal stress
Description
Self reported the perception of stress change from baseline to 6 months after childbirth using The Perceived Stress Scale
Time Frame
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Secondary Outcome Measure Information:
Title
postpartum medical records
Description
This instrument was to explore whether recording of pregnancy outcome in medical records
Time Frame
After the childbirth within 24 hours will be collected
Title
change of symptoms with depression and anxiety
Description
Self reported the symptoms with depression and anxiety change from baseline to 6 months after childbirth using the Edinburgh Postnatal Depression Scale
Time Frame
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Title
change of the childbirth self-efficacy
Description
Self reported the childbirth self-efficacy change from baseline to 6 months after childbirth using the Childbirth Self-Efficacy Inventory
Time Frame
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Title
change of mindfulness
Description
Self reported the mindfulness change from baseline to 6 months after childbirth using Five Factor Mindfulness Questionnaire
Time Frame
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Taking medication for diagnosing mental illness
With complicated or high-risk pregnancies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan-Lin Pan, MD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31601170
Citation
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.
Results Reference
derived
Learn more about this trial
Mindfulness-Based Childbirth and Parenting Education on Pregnant Women
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