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

National Defense Medical Center, Taiwan

Status: Not yet enrolling

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

Treatments: Behavioral: Intelligent intervention to enhance parent-child connection; Other: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT06987227

B2025050055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Intelligent intervention to enhance parent-child connection

Experimental group

Description:

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.

Treatment:

Other: Routine care

Behavioral: Intelligent intervention to enhance parent-child connection

Routine care group

Active Comparator group

Description:

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

Treatment:

Other: Routine care