Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants

Official title

Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants: a Randomized Controlled Trial

Overview

1. Construct intelligent management intervention plan for parents of preterm infants from hospital to family based on the medical and health system suitable for China's national conditions. 2. Clinical randomized controlled trials were conducted to verify and evaluate the feasibility and application effect of the intervention program.

Detailed description

Based on the previous literature analysis, this study builds an intelligent intervention scheme based on evidence-based methods and theories. Finally, we selected the parents of preterm infants in the neonatology department of a third class hospital in Shantou to carry out a similar experiment to verify the scheme. With data collected at five critical time points and different interventions provided according to baseline data, the study will reveal significant differences in personalized interventions, self-efficacy at different time points, and hospital discharge readiness among parents of preterm infants in the context of intelligent intervention, showing the relationship between self-efficacy and hospital discharge readiness. This study will fill in the single, traditional model of education and provide new perspectives and methods for future research and clinical practice.

Interventions

• Behavioral Information support
  The experimental group was given intervention measures. According to the general data survey, discharge readiness and self-efficacy assessment, parents were divided into low, middle and high discharge readiness groups and low, middle and high self-efficacy groups, respectively, using WeChat mini programs to push different content.
• Behavioral Stress and coping
  According to the results of self-efficacy and anxiety assessment, different interventions were based on different scores. Give encouragement and affirmation to parents with low anxiety and high self-efficacy. Parents with high anxiety and low self-efficacy should push stress relief methods such as mindfulness relaxation therapy in time. And through the wechat mini program to provide parents to respond to the pressure of the problem, the medical staff to give timely feedback.
• Behavioral Specialist guidance
  Carry out offline science popularization education and specialized training, and highly qualified specialist doctors and nurses will train parents, and parents will be assessed after training, and personalized guidance will be given according to the weak points of each parent\'s assessment.
• Other Social support and interaction
  Support and encouragement for parents continue from admission to discharge, so that parents feel that even after discharge, there are people to accompany and support them.
• Behavioral Parentage development
  Since parents and children are separated during the hospitalization of preterm infants, we will create an environment where parents still play the role of parents, and stimulate parental competence through kangaroo care, parental touch, and breastfeeding.

Primary outcome measures

• Parental readiness for discharge [Time frame: Upon admission and 24 hours before discharge]
• Parents' self-efficacy [Time frame: The day of admission, 24 hours before discharge, and 1 month after discharge]

Secondary outcome measures (5)

• Anxiety [Time frame: The day of admission, 24 hours before discharge, and 1 month after discharge]
• Growth and development indicators of premature infants [Time frame: 1 week, 1 month, 3 months after discharge]
• Readmission rate of preterm infants [Time frame: One month after discharge]
• Parental care ability [Time frame: The day of admission, 24 hours before discharge, and 1 month after discharge]
• Breastfeeding situation [Time frame: 1 week, 1 month, 3 months after discharge]

Eligibility criteria

Inclusion criteria

• Inclusion criteria for premature infants ① gestational age \< 37 weeks；② Premature infants admitted to NICU；③ The duration of hospitalization is more than 5 days.
• Inclusion and exclusion criteria of primary caregivers of preterm infants ① Preterm infants admitted to neonatology and family caregivers of preterm infants with gestational age \< 37 weeks. ② Family members who volunteer to undertake primary care tasks. ③ No mental disorders and can carry out normal language communication； ④ ≥18 years old, proficient in WeChat use；⑤ Informed consent has been signed.

Exclusion criteria

• Exclusion criteria for preterm infants ① intrauterine developmental retardation of preterm infants. ② Preterm infants with a history of major surgery. ③ Unplanned discharge, transfer, transfer or death of premature infants.
• Exclusion criteria for primary caregivers of preterm infants ① There are recent major mental trauma injuries caused by non-hospitalization factors. ② the caregiver suffers from serious diseases of the heart, brain, lung, kidney and other organs. 3. Shedding criteria: Caregivers who voluntarily asked to withdraw for various reasons during the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Lin K, Zhang S, Zhang Z, Zheng W, Chen Z, Lin Z, Zhang H, Lin N. Implementing intelligent nursing interventions to enhance self-efficacy and hospital readiness in parents of preterm infants: a randomised controlled trial protocol. BMJ Open. 2025 Aug 13;15(8):e101498. doi: 10.1136/bmjopen-2025-101498. PMID 40812802

Identifiers

NCT: NCT06635473 · SUMC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗