Augmented Reality for Managing Pediatric Anxiety and Pain During Disasters - A Randomized Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Proxy reported pain
研究概览
简要总结
The aim of this study is to test the feasibility of using Little NIRVANA (augmented reality (AR)) for managing anxiety and pain for children 2-8 years old during hospital emergency peripheral intravenous (PIV) insertions. The investigators hypothesize that Little NIRVANA plus a numbing cream will reduce pain and anxiety for patients undergoing PIV placement in the emergency department (ED) when compared to the cream alone. It is anticipated that using the Little NIRVANA will not increase the ED length of stay, failed PIV placement attempts, or the need for additional intervention.
详细描述
This is a two-group randomized clinical trial of 65 dyads of subjects and their parent and 65 proceduralists. Children will be randomly assigned to either the Little NIRVANA intervention group or a standard of care control group. Legal guardians of children in both groups will answer questions about their child's prior history of needle procedures, current pain/anxiety, medications taken prior to ED arrival, and video game experience. Children assigned to the intervention will play the game during the PIV placement, while children in the control group will receive the standard of care. The proceduralist performing the PIV placement and the parent will answer questions after the PIV placement about their perception of the child's pain and anxiety and questions about the Little NIRVANA experience for those children who were in the intervention group. This study has one visit that is completed during their ED stay.
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
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing PIV line placement (peripheral IV order placed while patient is in the ED);
- •Patients 2-8 years of age (inclusive)
排除标准
- •Non-English speaking (Little NIRVANA is currently only available in English and Dutch);
- •those for whom utilizing AR is deemed not feasible by the attending ED physician (e.g., critical illness)
研究组 & 干预措施
Intervention Group
Participants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement
干预措施: Little NIRVANA (Other)
Control
Treatment as usual - participants will receive a topical anesthetic cream but will not use the Little NIRVANA (other distraction methods available in the ED are allowed)
结局指标
主要结局
Proxy reported pain
时间窗: Immediately following the PIV line placement
0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum)-10(maximum), with higher score indicating worse pain.
Proxy reported anxiety
时间窗: Immediately following the PIV line placement
0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum )-10(maximum), with higher score indicating worse anxiety.
次要结局
- Proxy reported AR experience(Immediately following the PIV line placement)
研究者
Jonathan Chang
Emergency Medicine Physician
Nationwide Children's Hospital