Mindfulness-based Prenatal Education on Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Mindfulness-based prenatal education
* Behavioral: Hospital-based antenatal care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based prenatal education<br>The intervention includes 3-hour classes per week during the duration of eight weeks and a 7- hour silent meditation practice as well. | Behavioral: Mindfulness-based prenatal education<br>* Mindfulness-based prenatal education involves mindfulness breathing and other skills with mindfulness meditations.<br>|
| Placebo Comparator: Hospital-based antenatal education<br>Hospital-based antenatal education program. | Behavioral: Hospital-based antenatal care<br>* Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stress | 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 | baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression | 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 | baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum |