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Completed

NCT Number: NCT04693130

Mindfulness-based Prenatal Education on Women

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

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wan-Lin Pan

Taipei, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based prenatal education

Behavioral

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

Hospital-based antenatal care

Behavioral

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

Primary outcomes

  1. 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

  1. depression

    Time frame: 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

Other outcomes

  1. mindfulness

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

    The Five Facet Mindfulness Questionnaire, that was 39-item is based on factor analysis. The five facets of the FFMQ include: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scoring uses a 5-point Likert scale, with 1 representing "never or very rarely true" and 5 representing "very often or always true"

  2. anxiety

    Time frame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation.

    The Pregnancy-Related Thoughts Questionnaire (PRT), which uses a 10-item scale to measure a person's attention to baby health, labor, childbirth, and caring for babies over the past 7 days.indicated population by Robles et al. It consists of 21 items that evaluate symptoms of anxiety on a four-point Likert scale ranging from 0 = "not at all" to 3 = "severely." The anxiety level was scored using ordinal categories: minimal (1-5 points), mild (6-15), moderate (16-30) and severe (31-63)

  3. bonding

    Time frame: the follow-up at 2 , 4 months postpartum.

    The mother's feelings or attitudes toward her baby were assessed using the Postpartum Bonding Questionnaire (PBQ).

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 5, 2021
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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