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Набор скоро начнётся NCT06635473

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

Без фазы С лечением Premature Delivery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Information support, Stress and coping, Specialist guidance, Social support and interaction.
Кому может быть актуально
Состояния в реестре: Premature Delivery. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.
  • Поведенческое 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.
  • Поведенческое 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.
  • Другое 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.
  • Поведенческое 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.

Первичные конечные точки

  • Parental readiness for discharge [Срок оценки: Upon admission and 24 hours before discharge]
  • Parents' self-efficacy [Срок оценки: The day of admission, 24 hours before discharge, and 1 month after discharge]
Вторичные конечные точки (5)
  • Anxiety [Срок оценки: The day of admission, 24 hours before discharge, and 1 month after discharge]
  • Growth and development indicators of premature infants [Срок оценки: 1 week, 1 month, 3 months after discharge]
  • Readmission rate of preterm infants [Срок оценки: One month after discharge]
  • Parental care ability [Срок оценки: The day of admission, 24 hours before discharge, and 1 month after discharge]
  • Breastfeeding situation [Срок оценки: 1 week, 1 month, 3 months after discharge]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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

Идентификаторы

NCT: NCT06635473 · SUMC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗