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Идёт набор NCT07410858

Virtual Reality-Enhanced Parent Education in Neonatal Intensive Care

Без фазы С лечением Neonatal Intensive Care Units Premature Infant Parent Education Virtual Reality

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: Virtual Reality-Enhanced Parent Education.
Кому может быть актуально
Состояния в реестре: Neonatal Intensive Care Units, Premature Infant, Parent Education, Virtual Reality. Базовые параметры: от 18 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Virtual Reality-Enhanced Parent Education and Its Effect on Neonatal Intensive Care Practices: A Randomized Controlled Trial

Обзор

This randomized pilot clinical trial aims to evaluate the effectiveness and feasibility of virtual reality (VR)-enhanced parent education in improving neonatal intensive care unit (NICU) caregiving practices among parents of hospitalized neonates. The study will also examine the safety and tolerability of VR use among parents. Researchers will compare VR-enhanced education with standard NICU parent education to determine whether immersive VR training improves parents' knowledge, confidence, and ability to perform caregiving tasks. Participants will be randomly assigned to receive either VR-enhanced education or standard education. Participants receiving VR education will engage in short immersive sessions demonstrating NICU orientation and caregiving procedures. All participants will complete assessments and observations related to caregiving practices and VR tolerability throughout the study period.

Подробное описание

The NICU environment presents significant emotional, educational, and practical challenges for parents of preterm or critically ill neonates. Effective parent education is essential for improving caregiving competence, reducing parental anxiety, and supporting family-integrated neonatal care. However, traditional education methods such as verbal instructions and printed materials may be limited by time constraints, parental stress, and variations in health literacy.

Virtual reality technology provides immersive, interactive educational experiences that may enhance understanding, engagement, and retention of caregiving information. VR simulations can provide parents with guided orientation to NICU equipment, caregiving demonstrations, and exposure to real-life caregiving scenarios in a safe, controlled environment.

This study is designed as a single-center, randomized, parallel-group pilot trial conducted in a neonatal intensive care unit setting. The primary purpose of the trial is to evaluate feasibility outcomes including recruitment, adherence, retention, and VR tolerability, as well as to generate preliminary estimates of effect size and variability to inform future large-scale trials.

Participants assigned to the intervention group will receive a standardized VR education package consisting of immersive orientation and caregiving simulation sessions delivered using a VR headset. Sessions will include demonstrations of routine neonatal care activities and structured debriefing discussions to reinforce learning and address parental questions.

Participants assigned to the control group will receive routine NICU parent education delivered through conventional methods currently implemented in clinical practice.

Data collection will include assessments of parental knowledge, direct observation of caregiving practices, and evaluation of VR-related tolerability and user experience. Observations of caregiving practices will be conducted by trained observers who are blinded to group allocation to reduce assessment bias.

The results of this pilot trial will provide essential data regarding feasibility, acceptability, safety, and potential effectiveness of VR-enhanced parent education. Findings will be used to refine intervention procedures, improve study methodology, and support the development of a larger definitive randomized clinical trial aimed at improving neonatal outcomes and family-centered care in NICU settings.

Вмешательства

  • Поведенческое Virtual Reality-Enhanced Parent Education
    Participants receive virtual reality-enhanced parent education including immersive NICU orientation and caregiving simulation sessions delivered using a VR headset, followed by structured debriefing.

Первичные конечные точки

  • Parental Neonatal Intensive Care Unit Caregiving Practices [Срок оценки: Within 24-48 hours after completion of the parent education intervention]

Критерии участия

Критерии включения

  • Parent or legal guardian of a neonate admitted to the Neonatal Intensive Care Unit (NICU) within 72 hours of admission
  • Age 18 years or older
  • Able to read and understand the study language (Arabic)
  • Willing to provide informed consent and participate in study procedures

Критерии исключения

  • Parent with a confirmed diagnosis of epilepsy, vestibular disorder, or any medical condition that contraindicates virtual reality exposure
  • Parent of a neonate expected to be discharged or transferred within 48 hours
  • Parent unable to complete study procedures or assessments

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
Поддерживающая терапия

Центры проведения

Египет · 1 центр
  • Neonatal Intensive Care Unit (NICU), Suez Canal University Hospital — Ismailia

Идентификаторы

NCT: NCT07410858 · 351-12-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗