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Mother-infant Connection Strategy Program

Mother-infant Connection Strategy Program: Impact on Psychological Distress and Mother-infant Bonding in Women

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06237088
Enrollment
142
Registered
2024-02-01
Start date
2023-01-30
Completion date
2026-01-30
Last updated
2024-02-01

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

Conditions

Mother-Infant Interaction, Psychological

Keywords

Mindfulness, Anxiety, Depression, Mother-Infant Interaction

Brief summary

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

Detailed 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.

Interventions

OTHERonline 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.

OTHEReight-week mindfulness programs

The intervention consists of 2.5-hour classes per week over a period of eight weeks.

Sponsors

National Taipei University of Nursing and Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
anxietybaseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartumThe 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.
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
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
mother-infant bondingthe follow-up at 2 , 4 months postpartum.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.

Countries

Taiwan

Contacts

Primary ContactWan-Lin Pan, PHD
wanlimp@gmail.com886-2-28227101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026