Mindfulness-Based Childbirth and Parenting Education on Pregnant Women

Pregnancy Related Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03185910
• Other study ID #: 104-E-20
• Status: Active, not recruiting
• Phase: N/A
• First received: May 27, 2017
• Last updated: June 10, 2017
• Start date: February 3, 2016
• Est. completion date: February 28, 2018

Study information

• Verified date: June 2017
• Source: National Taiwan University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: February 28, 2018
• Est. primary completion date: December 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Stress, Psychological

Intervention

Behavioral:
• MBCP education
MBCP education involves mindfulness breathing and other skills with mindfulness meditations.
• Hospital-based antenatal education
Hospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University of Nursing and Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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