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Clinical Trials/NCT04693130
NCT04693130
Completed
Not Applicable

Effects of Mindfulness-based Prenatal Education on Biopsychological Health for Prenatal Mental Disorders Women

National Taipei University of Nursing and Health Sciences1 site in 1 country102 target enrollmentDecember 24, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression, Anxiety
Sponsor
National Taipei University of Nursing and Health Sciences
Enrollment
102
Locations
1
Primary Endpoint
stress
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to explore the differences between stress, anxiety, depression, mindfulness, mother and infants bonding, salivary amylase activity, and postnatal maternal outcomes for prenatal mental disorders in women with mindfulness prenatal education program

Detailed Description

The aim of this study was to test the efficacy of a Mindfulness prenatal education program in reducing pregnant women's perceived stress, anxiety, depression, mindfulness, mother and infant bonding, and salivary alpha-amylase compared to a control group. The investigators hypothesize that using the mindfulness prenatal education program by the study group will lead to improved related mood symptoms compared with the control group. 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 30%, total 102 samples.

Registry
clinicaltrials.gov
Start Date
December 24, 2020
End Date
February 3, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
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 at the age over 20
  • Could speak and read Chinese fluently
  • Willing and be ale to attend the education program

Exclusion Criteria

  • Taking medication for diagnosing mental illness
  • With complicated or high-risk pregnancies

Outcomes

Primary Outcomes

stress

Time Frame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

Perceived stress scale, that was 10 items to determine the self-perceived levels of unpredictability, lack of control, and burden during the last month of pregnancy. Responses are rated from 0 (never) to 4 (very often), with higher scores corresponding to higher perceived stress

Secondary Outcomes

  • depression(baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum)

Study Sites (1)

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