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Clinical Trials/NCT04693130
NCT04693130CompletedNot Applicable

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

National Taipei University of Nursing and Health Sciences2 sites in 1 country102 target enrollmentStarted: December 24, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
102
Locations
2
Primary Endpoint
stress

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wan-Lin Pan

Nursing department

National Taipei University of Nursing and Health Sciences

Study Sites (2)

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