Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT06987227
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.
Study:
NCT06987227
Study Brief:
Protocol Section:
NCT06987227