Mindfulness-based Prenatal Education on Women

NCT ID: NCT04693130

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-24

Study Completion Date

2023-02-03

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.

Conditions

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Depression, Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness-based prenatal education

Intervention Type BEHAVIORAL

Mindfulness-based prenatal education involves mindfulness breathing and other skills with mindfulness meditations.

Hospital-based antenatal education

Hospital-based antenatal education program.

Group Type PLACEBO_COMPARATOR

Hospital-based antenatal care

Intervention Type BEHAVIORAL

Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum.

Interventions

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Mindfulness-based prenatal education

Mindfulness-based prenatal education involves mindfulness breathing and other skills with mindfulness meditations.

Intervention Type BEHAVIORAL

Hospital-based antenatal care

Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Wan-Lin Pan

Nursing department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wan-Lin Pan, PHD

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

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Wan-Lin Pan

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Pan WL, Lin LC, Kuo LY, Chiu MJ, Ling PY. Effects of a prenatal mindfulness program on longitudinal changes in stress, anxiety, depression, and mother-infant bonding of women with a tendency to perinatal mood and anxiety disorder: a randomized controlled trial. BMC Pregnancy Childbirth. 2023 Jul 31;23(1):547. doi: 10.1186/s12884-023-05873-2.

Reference Type DERIVED
PMID: 37525110 (View on PubMed)

Other Identifiers

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108-E-14

Identifier Type: -

Identifier Source: org_study_id

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