Clinical trial NCT06987227: Effects of Intelligent Parent-child Bonding Intervention on the Physical, Psychological and Social Health of Parents of Premature Infants During Hospitalization and Return Home
Official title: Effects of a Smart Parent-child Bonding Intervention on the Physical, Psychological, and Social Health of Parents of Preterm Infants During Hospitalization and Home Return: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parents of Premature Infants
Intelligent Intervention
Parent-child Connection
Keywords: physical health
psychological health
parents of premature infants
social health
Intelligent intervention
parent-child connection
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 360
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: The Pittsburgh Sleep Quality Index, PSQI
timeFrame: Changes in parents' sleep patterns before premature infants are discharged from hospital and in the first month after premature infants return home
measure: Actigraphy and Sleep Diary measures sleep details
timeFrame: Changes in parents' sleep details before premature infants are discharged from hospital and in the first month after premature infants return home
measure: Brief Fatigue Inventory, BFI
timeFrame: Changes in parental fatigue before premature infants were discharged from hospital and in the first month after they returned home
measure: Perceived Stress Scale, PSS
timeFrame: Changes in parental perceived stress before premature infants were discharged from hospital and in the first month after they returned home
measure: Postpartum Specific Anxiety Scale
timeFrame: Changes in parental anxiety before premature infants were discharged from hospital and in the first month after they returned home
measure: Edinburgh Postpartum Depression Scale
timeFrame: Changes in parental depression before premature infants were discharged from hospital and in the first month after they returned home
measure: Parental Self-efficacy scale, PSE Scale
timeFrame: Changes in parental self-efficacy before premature infants were discharged from hospital and in the first month after they returned home
measure: Parent-infant bonding
timeFrame: Changes in parent-infant bonding before premature infants were discharged from hospital and in the first month after they returned home
measure: Relationship Assessment Scale, RAS
timeFrame: Changes in parental relationship before premature infants were discharged from hospital and in the first month after they returned home
measure: Family Resilience Assessment
timeFrame: Changes in family resilience before premature infants were discharged from hospital and in the first month after they returned home
measure: World Health Organization Quality of Life-BREF, WHOQOL-BREF
timeFrame: Changes in quality of life before premature infants were discharged from hospital and in the first month after they returned home
Secondary outcomes:
Other outcomes:
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