Mindfulness-Based Childbirth and Parenting Education on Pregnant Women

Not Applicable

• Conditions: Stress, Psychological; Pregnancy Related
• Interventions: Behavioral: MBCP education; Behavioral: Hospital-based antenatal education

• Registration Number: NCT03185910
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

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.

Study Timeline

• Study Start: 2016-02-03
• Study First Submitted: 2017-05-27
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-10
• Last Update Submitted: 2017-06-10
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Primary Completion: 2017-12-02
• Study Completion: 2018-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBCP education	MBCP education	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	Hospital-based antenatal education	Hospital-based antenatal education program will be held 2 hrs once a month for 2 months.

Primary Outcome Measures

Name	Time	Method
change of prenatal and postnatal stress	Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth	Self reported the perception of stress change from baseline to 6 months after childbirth using The Perceived Stress Scale

Secondary Outcome Measures

Name	Time	Method
change of mindfulness	Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth	Self reported the mindfulness change from baseline to 6 months after childbirth using Five Factor Mindfulness Questionnaire
postpartum medical records	After the childbirth within 24 hours will be collected	This instrument was to explore whether recording of pregnancy outcome in medical records
change of the childbirth self-efficacy	Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth	Self reported the childbirth self-efficacy change from baseline to 6 months after childbirth using the Childbirth Self-Efficacy Inventory
change of symptoms with depression and anxiety	Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth	Self reported the symptoms with depression and anxiety change from baseline to 6 months after childbirth using the Edinburgh Postnatal Depression Scale