跳至主要内容
临床试验/NCT07410858
NCT07410858招募中不适用

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

Jouf University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Parental Neonatal Intensive Care Unit Caregiving Practices

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Due to the nature of the educational intervention, participants and care providers cannot be blinded to group assignment. However, trained observers assessing parental caregiving practices and data analysts will remain blinded to allocation to reduce assessment bias.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Standard Parent Education

No Intervention

Participants receive routine NICU parent education including verbal instructions and printed educational materials according to unit standard practice.

VR-Enhanced Parent Education

Experimental

Participants receive virtual reality-enhanced parent education including immersive NICU orientation and caregiving simulation sessions delivered using a VR headset, followed by structured debriefing.

干预措施: Virtual Reality-Enhanced Parent Education (Behavioral)

结局指标

主要结局

Parental Neonatal Intensive Care Unit Caregiving Practices

时间窗: Within 24-48 hours after completion of the parent education intervention

Parental caregiving practices will be assessed using a structured observational checklist measuring performance of bedside neonatal care activities, including hand hygiene, safe positioning and containment, diapering and basic hygiene, and non-nutritive soothing and clustering of care. Each checklist item is scored as completed or not completed, with higher total scores indicating better caregiving practice performance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadia Elsharkawy

Associate Professor

Jouf University

研究点 (1)

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