Mindfulness-Based Childbirth and Parenting Education on Pregnant Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stress, Psychological, Pregnancy Related

Intervention / Treatment
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* Behavioral: MBCP education
* Behavioral: Hospital-based antenatal education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCP education<br>The intervention includes 3-hour classes per week during the duration of eight weeks and a 7- hour silent meditation practice as well. | Behavioral: MBCP education<br>* MBCP education involves mindfulness breathing and other skills with mindfulness meditations.<br>|
| Placebo Comparator: Hospital-based antenatal education<br>Hospital-based antenatal education program will be held 2 hrs once a month for 2 months. | Behavioral: Hospital-based antenatal education<br>* Hospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postpartum medical records | This instrument was to explore whether recording of pregnancy outcome in medical records | After the childbirth within 24 hours will be collected | 
| 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 | Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth | 
| 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 | Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth | 
| change of mindfulness | Self reported the mindfulness change from baseline to 6 months after childbirth using Five Factor Mindfulness Questionnaire | Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth |