Mother-infant Connection Strategy Program

NCT ID: NCT06237088

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2026-01-30

Brief Summary

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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

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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.

Conditions

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Psychological Mother-Infant Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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eight-week mindfulness programs

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

Group Type ACTIVE_COMPARATOR

eight-week mindfulness programs

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

online mindfulness program

Intervention Type OTHER

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.

care as usual

Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

eight-week mindfulness programs

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Wan-Lin Pan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wan-Lin Pan, PHD

Role: PRINCIPAL_INVESTIGATOR

assistant professor

Locations

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Wan-Lin Pan

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wan-Lin Pan, PHD

Role: CONTACT

886-2-28227101 ext. 3131

Facility Contacts

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WAN-LIN PAN, PHD

Role: primary

0933710737

Other Identifiers

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111-E-21

Identifier Type: -

Identifier Source: org_study_id

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