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Mindfulness-based Prenatal Education on Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04693130
Enrollment
102
Registered
2021-01-05
Start date
2020-12-24
Completion date
2023-02-03
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Anxiety

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.

Interventions

BEHAVIORALMindfulness-based prenatal education

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

BEHAVIORALHospital-based antenatal care

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

Sponsors

National Taipei University of Nursing and Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
stressbaseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartumPerceived 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

MeasureTime frameDescription
depressionbaseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartumEdinburgh 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

MeasureTime frameDescription
mindfulnessbaseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartumThe 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
anxietybaseline , 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)
bondingthe follow-up at 2 , 4 months postpartum.The mother's feelings or attitudes toward her baby were assessed using the Postpartum Bonding Questionnaire (PBQ).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026