Effectiveness of Virtual Reality in Reducing Anxiety, Fear, and Pain in Pediatric Patients Undergoing Skin Prick Testing: A Cross-Over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- change of procedural anxiety in pediatric patients undergoing skin prick test
研究概览
简要总结
Skin prick testing (SPT) is a cornerstone diagnostic procedure for identifying allergic sensitizations in pediatric patients. Despite being minimally invasive, it often provokes considerable anxiety, fear, and pain, potentially compromising test accuracy due to poor compliance. Virtual Reality (VR) has emerged as a promising non-pharmacological tool for procedural distress management, yet its application in allergy diagnostics remains underexplored.
To evaluate the effectiveness of VR in reducing procedural anxiety, fear, and pain, and in improving compliance in children undergoing SPT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a confirmed history of allergic symptoms related to either environmental or food allergens
- •between 4 and 18 years of age
排除标准
- •history of seizure disorders,
- •motion sickness,
- •severe developmental delay,
- •non-Italian-speaking patients
- •Participants who had used systemic antihistamines or corticosteroids within the past seven days
结局指标
主要结局
change of procedural anxiety in pediatric patients undergoing skin prick test
时间窗: during the procedure
The primary objective of this study was to evaluate the effectiveness of VR in reducing procedural anxiety in pediatric patients undergoing SPT. Anxiety levels were assessed using the CAM scale before (0), during (1), post procedure, i.e., one minute after the procedure (2).
次要结局
未报告次要终点
研究者
Roberto Berni Canani, MD, PhD
Full Professor
Federico II University