Mindfulness-based Prenatal Education on Women

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

Study Overview

• Status: Completed
• Conditions: Depression, Anxiety
• Intervention / Treatment: Behavioral: Mindfulness-based prenatal education; Behavioral: Hospital-based antenatal care

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Wan-Lin Pan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mindfulness-based prenatal education; Mindfulness-based prenatal education involves mindfulness breathing and other skills with mindfulness meditations.
Placebo Comparator: Hospital-based antenatal education; Hospital-based antenatal education program.	Behavioral: Hospital-based antenatal care; Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Investigators: Principal Investigator: Wan-Lin Pan, PHD, National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2020
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 108-E-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No