Effects of Intelligent Parent-child Bonding Intervention on the Physical, Psychological and Social Health of Parents of Premature Infants During Hospitalization and Return Home

NCT ID: NCT06987227

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2028-03-31

Brief Summary

The study purpose is to construct and validate the effects of "intelligent parent-child bonding intervention" on the physical, psychological and social health of parents of premature infants.

Detailed Description

Background:

Premature babies are born at 20 weeks but less than 37 weeks of gestation. In 2020, there were approximately 13.4 million premature babies worldwide, accounting for 10% of the total number of newborns. Although Taiwan's birth rate has declined, the premature birth rate has increased year by year due to factors such as late marriage and childbirth at an advanced age, reaching 10.88% in 2023. Premature birth survivors face long-term physical and psychological challenges that affect their quality of life and cause significant stress for their families, including anxiety and depression. Mother-child separation is considered "toxic stress" that affects parent-child relationships and family function. Therefore, establishing a bond with your newborn is critical to the health of both the parents and the premature infant.

Methods:

This study was a three-year randomized controlled trial using a longitudinal repeated measures design. Convenience sampling will be used to recruit 360 parents of premature infants in the pediatric and neonatal intensive care unit of a northern medical center. Participants will be randomly assigned to two conditions (usual care and smart parent-child bonding intervention). The intervention will begin during the premature infant's hospital stay until the first month after discharge. Data will be collected using questionnaires and biometrics. Outcome variables included sleep status, fatigue, stress, anxiety, depression, self-efficacy, parent-child connection, partner relationship, family resilience, and quality of life of parents of preterm infants. In addition, these data will be collected before the intervention, 2 weeks after the intervention, before premature infants are discharged from the hospital, and in the first month after premature infants return home. It is expected that the generalized estimating equation method will be used to analyze the research results.

Conditions

Parents of Premature Infants; Intelligent Intervention; Parent-child Connection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intelligent intervention to enhance parent-child connection

In addition to routine care, premature infants will receive "intelligent parent-child connection intervention" during hospitalization and continue to use it until one month after the premature infant returns home.

Group Type: EXPERIMENTAL

Intelligent intervention to enhance parent-child connection

Intervention Type: BEHAVIORAL

The "Intelligent Intervention to Enhance Parent-Child Connection" support program is mainly carried out through web pages, Figma software, cloud files and official Line accounts. It can be divided into: the first stage is to provide parents with care knowledge and skills during the hospitalization of premature infants, provide parents with physical and mental support, and encourage parents to establish parent-child connections and prepare for discharge. The second stage is after discharge, continuing to provide premature infants' families with the care guidance needed to respond to the different stages of development of premature infants, including interpersonal support, sleep schedule establishment, crying comfort, premature infant nutrition and couple relationship management, etc., and continue to provide family support, answer questions and track its implementation status.

Routine care

Intervention Type: OTHER

Premature infants receive routine care during their hospitalization, and general nursing guidance for premature infant discharge care is provided before discharge.

Routine care group

Routine care is provided to premature infants during hospitalization, and general nursing guidance for premature infant discharge care is provided before discharge.

Group Type: ACTIVE_COMPARATOR

Routine care

Intervention Type: OTHER

Premature infants receive routine care during their hospitalization, and general nursing guidance for premature infant discharge care is provided before discharge.

Interventions

Intelligent intervention to enhance parent-child connection

The "Intelligent Intervention to Enhance Parent-Child Connection" support program is mainly carried out through web pages, Figma software, cloud files and official Line accounts. It can be divided into: the first stage is to provide parents with care knowledge and skills during the hospitalization of premature infants, provide parents with physical and mental support, and encourage parents to establish parent-child connections and prepare for discharge. The second stage is after discharge, continuing to provide premature infants' families with the care guidance needed to respond to the different stages of development of premature infants, including interpersonal support, sleep schedule establishment, crying comfort, premature infant nutrition and couple relationship management, etc., and continue to provide family support, answer questions and track its implementation status.

Intervention Type: BEHAVIORAL

Routine care

Premature infants receive routine care during their hospitalization, and general nursing guidance for premature infant discharge care is provided before discharge.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. Parents of premature infants born less than 37 weeks of age; 2. Parents of premature infants aged 20 or above and able to communicate in Mandarin and Taiwanese; 3. Parents of premature infants agree to participate in this study and sign the research consent form; 4. The child is currently in the Pediatric and Neonatal Intensive Care Center

Exclusion Criteria: 1. The premature baby has congenital abnormalities or is in critical condition and cannot survive; 2. The parents cannot use mobile phones or other Internet devices; 3. The parents have a history of mental illness, intellectual disability or substance abuse.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Defense Medical Center, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Hsiang-Yun Lan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lan Hsiang-Yun, A.P.

Role: CONTACT

shinnylan@gmail.com

+886287923100 Ext. 18781

Other Identifiers

B2025050055

Identifier Type: -

Identifier Source: org_study_id