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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• The Pittsburgh Sleep Quality Index, PSQI [Срок оценки: Changes in parents' sleep patterns before premature infants are discharged from hospital and in the first month after premature infants return home]
• Actigraphy and Sleep Diary measures sleep details [Срок оценки: Changes in parents' sleep details before premature infants are discharged from hospital and in the first month after premature infants return home]
• Brief Fatigue Inventory, BFI [Срок оценки: Changes in parental fatigue before premature infants were discharged from hospital and in the first month after they returned home]
• Perceived Stress Scale, PSS [Срок оценки: Changes in parental perceived stress before premature infants were discharged from hospital and in the first month after they returned home]
• Postpartum Specific Anxiety Scale [Срок оценки: Changes in parental anxiety before premature infants were discharged from hospital and in the first month after they returned home]
• Edinburgh Postpartum Depression Scale [Срок оценки: Changes in parental depression before premature infants were discharged from hospital and in the first month after they returned home]
• Parental Self-efficacy scale, PSE Scale [Срок оценки: Changes in parental self-efficacy before premature infants were discharged from hospital and in the first month after they returned home]
• Parent-infant bonding [Срок оценки: Changes in parent-infant bonding before premature infants were discharged from hospital and in the first month after they returned home]
• Relationship Assessment Scale, RAS [Срок оценки: Changes in parental relationship before premature infants were discharged from hospital and in the first month after they returned home]
• Family Resilience Assessment [Срок оценки: Changes in family resilience before premature infants were discharged from hospital and in the first month after they returned home]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Тайвань · 1 центр

• Hsiang-Yun Lan — Teipei

Идентификаторы

NCT: NCT06987227 · B2025050055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗