Mindfulness-Based Childbirth and Parenting Education on Pregnant Women

June 10, 2017 updated by: Wan-Lin Pan, National Taipei University of Nursing and Health Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Hospital-based antenatal education
Hospital-based antenatal education program will be held 2 hrs once a month for 2 months.
Behavioral: Hospital-based antenatal education
Hospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum.
Experimental: 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.
Behavioral: MBCP education
MBCP education involves mindfulness breathing and other skills with mindfulness meditations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: After the childbirth within 24 hours will be collected
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
Time Frame: 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
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
change of the childbirth self-efficacy
Time Frame: 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
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
change of mindfulness
Time Frame: 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
Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Investigators

  • Principal Investigator: Wan-Lin Pan, MD, National Taipei University of Nursing and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2016

Primary Completion (Anticipated)

December 2, 2017

Study Completion (Anticipated)

February 28, 2018

Study Registration Dates

First Submitted

May 27, 2017

First Submitted That Met QC Criteria

June 10, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 10, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-E-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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