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Clinical Trials/NCT03185910
NCT03185910
Unknown
N/A

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

National Taipei University of Nursing and Health Sciences0 sites104 target enrollmentFebruary 3, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stress, Psychological
Sponsor
National Taipei University of Nursing and Health Sciences
Enrollment
104
Primary Endpoint
change of prenatal and postnatal stress
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2016
End Date
February 28, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wan-Lin Pan

Nursing department

National Taipei University of Nursing and Health Sciences

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

Outcomes

Primary Outcomes

change of prenatal and postnatal stress

Time Frame: 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 Outcomes

  • change of mindfulness(Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth)
  • postpartum medical records(After the childbirth within 24 hours will be collected)
  • change of the childbirth self-efficacy(Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth)
  • change of symptoms with depression and anxiety(Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth)

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