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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06237088
Other study ID # 111-E-21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date January 30, 2026

Study information

Verified date January 2024
Source National Taipei University of Nursing and Health Sciences
Contact Wan-Lin Pan, PHD
Phone 886-2-28227101
Email wanlimp@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluated the long-term effects of an online mindfulness-based program on the psychological distress and mother-infant bonding of women


Description:

The aim of this study was to test the efficacy of an online mindfulness program in reducing women's perceived stress, anxiety, depression, and in enhancing mindfulness and mother-infant bonding compared to a control group. The investigators hypothesize that the use of an online mindfulness program or an eight-week mindfulness program by the two experimental groups will lead to improved mood symptoms and mother-infant bonding compared with the control group. A randomized controlled trial comparing three groups of healthy, singleton pregnant women was conducted using the Random Allocation Software (Saghaei, 2004). We used G-Power 3.1.9 for Windows to analyze the minimum effect size that would be statistically significant with an 80% probability, using an alpha error probability of 0.05 in the "ANOVA: Repeated measures, between factors" option. We inputted 3 for the number of groups, 4 for the number of measurements, 0.5 for the correlation between repeated measures, and factored in a 20% attrition rate. There are 41 women in each group.


Recruitment information / eligibility

Status Recruiting
Enrollment 142
Est. completion date January 30, 2026
Est. primary completion date January 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects were at the age over 18 - 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 Design


Related Conditions & MeSH terms


Intervention

Other:
online mindfulness program
The intervention includes an eight-week internet-based mindfulness program. The program introduces participants to a new mindfulness topic every week. These topics are heavily inspired by the eight-week mindfulness programs.
eight-week mindfulness programs
The intervention consists of 2.5-hour classes per week over a period of eight weeks.

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
Primary anxiety The Beck Anxiety Inventory using 21 items on the scale describes a symptom of anxiety. Responses are rated from 0 (never) to 3 (very often), with higher scores corresponding to higher perceived anxiety. baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
Primary 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
Primary 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
Primary mother-infant bonding The Postpartum Bonding Questionnaire, that was 25 items, with four factors. The first factor was labelled general emotional factor, the second anger towards and rejection of baby; the third infant-focus anxiety; and the fourth, risk of abuse. the follow-up at 2 , 4 months postpartum.
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