Mindfulness-based Prenatal Education on Women

Not Applicable

Completed

• Conditions: Depression, Anxiety
• Interventions: Behavioral: Mindfulness-based prenatal education; Behavioral: Hospital-based antenatal care

• Registration Number: NCT04693130
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

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 Timeline

• Study Start: 2020-12-24
• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Primary Completion: 2022-03-03
• Status Verified: 2023-02
• Study Completion: 2023-02-03
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mindfulness-based prenatal education	Mindfulness-based prenatal education	The intervention includes 3-hour classes per week during the duration of eight weeks and a 7- hour silent meditation practice as well.
Hospital-based antenatal education	Hospital-based antenatal care	Hospital-based antenatal education program.

Primary Outcome Measures

Name	Time	Method
stress	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 Outcome Measures

Name	Time	Method
depression	baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum	Edinburgh Perinatal Depression Scale, that was 10-question questionnaire provides a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with item scores summed to produce a total score

Trial Locations

Locations (1)

Wan-Lin Pan; 🇨🇳 Taipei, Taiwan