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Mother-infant Connection Strategy Program

N

National Taipei University of Nursing and Health Sciences

Status

Enrolling

Conditions

Psychological
Mother-Infant Interaction

Treatments

Other: eight-week mindfulness programs
Other: online mindfulness program

Study type

Interventional

Funder types

Other

Identifiers

NCT06237088
111-E-21

Details and patient eligibility

About

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

Full 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.

Enrollment

142 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

142 participants in 3 patient groups

eight-week mindfulness programs
Active Comparator group
Description:
The intervention consists of 2.5-hour classes per week over a period of eight weeks.
Treatment:
Other: eight-week mindfulness programs
online mindfulness program
Experimental group
Description:
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.
Treatment:
Other: online mindfulness program
care as usual
No Intervention group
Description:
Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum.

Trial contacts and locations

1

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Central trial contact

Wan-Lin Pan, PHD

Data sourced from clinicaltrials.gov

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