The Impact of Virtual Reality Application Before Endoscopy on Anxiety and Vital Signs in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Reduction in Anxiety Levels in Pediatric Patients
研究概览
简要总结
Brief Summary: Clinical Study
The purpose of this clinical study is to evaluate whether the use of virtual reality (VR) before endoscopy reduces anxiety levels and positively impacts vital signs in children. This study aims to answer the following key questions:
Does the VR application reduce pre-endoscopy anxiety in children? Does the VR application improve vital signs such as heart rate, blood pressure, and oxygen saturation in children?
Researchers will compare the effects of the VR application with standard care to assess its effectiveness.
Participants:
The experimental group will undergo a 15-minute VR session before the endoscopy.
The control group will receive standard care without VR. Anxiety levels and vital signs will be measured throughout the study.
This study aims to explore whether VR technology can serve as an effective stress management tool during pediatric medical procedure
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
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 8 to 17 years.
- •Scheduled to undergo an endoscopy procedure.
- •Able to provide assent, and their parents or legal guardians provide written informed consent.
- •No prior exposure to virtual reality applications.
- •Willing to participate in the study.
排除标准
- •Presence of a chronic medical condition affecting cardiovascular or respiratory systems.
- •Diagnosed with a severe psychiatric disorder.
- •Known visual or auditory impairments that could prevent participation in a virtual reality session.
- •History of seizures or epilepsy.
- •Unwillingness to participate or inability to comply with study procedures.
结局指标
主要结局
Reduction in Anxiety Levels in Pediatric Patients
时间窗: Anxiety levels will be measured immediately before the intervention and immediately after the intervention on the same day as the endoscopy procedure.
The primary outcome measure is the change in anxiety levels among pediatric patients undergoing endoscopy. Anxiety levels will be assessed using the State-Trait Anxiety Inventory for Children (STAIC), a validated tool for measuring anxiety in children. Scores will be measured before and after the intervention to determine the effectiveness of the virtual reality (VR) application compared to the control group receiving standard care.
次要结局
未报告次要终点
研究者
mehmet bulduk
PhD
Yuzuncu Yıl University