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Mother-infant Connection Strategy Program

Not Applicable
Recruiting
Conditions
Psychological
Mother-Infant Interaction
Interventions
Other: online mindfulness program
Other: eight-week mindfulness programs
Registration Number
NCT06237088
Lead Sponsor
National Taipei University of Nursing and Health Sciences
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
142
Inclusion Criteria
  • Subjects were at the age over 18
  • Could speak and read Chinese fluently
  • Willing and be ale to attend the education program
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Exclusion Criteria
  • Taking medication for diagnosing mental illness
  • With complicated or high-risk pregnancies
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
online mindfulness programonline mindfulness programThe 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 programseight-week mindfulness programsThe intervention consists of 2.5-hour classes per week over a period of eight weeks.
Primary Outcome Measures
NameTimeMethod
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.

anxietybaseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

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.

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

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

mindfulnessbaseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

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"

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Wan-Lin Pan

🇨🇳

Taipei, Taiwan

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