Mindfulness-based Prenatal Education on Women

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693130
• Other study ID #: 108-E-14
• Status: Completed
• Phase: N/A
• Start date: December 24, 2020
• Est. completion date: February 3, 2023

Study information

• Verified date: February 2023
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 3, 2023
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Behavioral:
• Mindfulness-based prenatal education
Mindfulness-based prenatal education involves mindfulness breathing and other skills with mindfulness meditations.
• Hospital-based antenatal care
Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum.

Locations

Country	Name	City	State
Taiwan	Wan-Lin Pan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mindfulness	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"	baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
Other	anxiety	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)	baseline , and at eight weeks (after the intervention), 36 weeks of gestation.
Other	bonding	The mother's feelings or attitudes toward her baby were assessed using the Postpartum Bonding Questionnaire (PBQ).	the follow-up at 2 , 4 months postpartum.
Primary	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	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