Clinical trial NCT03185910: Mindfulness-Based Childbirth and Parenting Education on Pregnant Women
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Pregnancy Related
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 104
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: change of prenatal and postnatal stress
timeFrame: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Secondary outcomes:
measure: postpartum medical records
timeFrame: After the childbirth within 24 hours will be collected
measure: change of symptoms with depression and anxiety
timeFrame: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
measure: change of the childbirth self-efficacy
timeFrame: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
measure: change of mindfulness
timeFrame: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Other outcomes:
Locations:
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Wan-Lin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan WL, Chang CW, Chen SM, Gau ML. Assessing the effectiveness of mindfulness-based programs on mental health during pregnancy and early motherhood - a randomized control trial. BMC Pregnancy Childbirth. 2019 Oct 10;19(1):346. doi: 10.1186/s12884-019-2503-4.