The Utilization of Virtual Reality Technology Versus Standard of Care During Pediatric Oral Food Challenge: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in Children's Fear Scale Score Before and After OFC dosing
研究概览
简要总结
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care of utilizing existing technologies that are currently more common in food allergy research treatment and clinics (i.e. television and patients' personal electronic devices) for decreasing levels anxiety and fear in pediatric patients undergoing oral food challenge (OFC) and their caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 5 and 17
- •Willing to participate in both the VR and standard of care technology conditions
- •Able to consent or have parental consent
- •Undergoing at least two Oral Food Challenges within the window of recruitment at the Sean N. Parker Center
排除标准
- •People who do not consent
- •Significant Cognitive Impairment
- •History of Severe Motion Sickness
- •Current Nausea
- •Visual Problems
- •Non-English Speaking
- •Patients who clinically unstable or requires urgent/emergent intervention
- •ASA class 4 or higher
结局指标
主要结局
Change in Children's Fear Scale Score Before and After OFC dosing
时间窗: measurements occur at single time points before and after each food challenge with approximately 4-6 hours between measurements. Thus 4 discrete measurements will be taken over two food challenges which will occur approximately one week apart.
The Children's Fear Scale (CFS) is used to measure the anxiety or fear level of the children. The one-item scale consists of a row of five sex neutral faces ranging from a no fear (neutral) face on the far left to a face showing extreme fear on the far right.
Change in Childhood Anxiety Meter Score Before and After OFC dosing
时间窗: Before and after each evaluation (approximately 4-6 hours between measurements at each visit, with visits approximately 1 week apart)
The Childhood Anxiety Meter brief measure of the current level of anxiety in a child using a visual scale (thermometer that is colored to the level anxiety, higher thermometer level means more anxiety).
次要结局
- Level of satisfaction - participant, caregiver and provider(After each evaluation (approximately 1 week apart))
- Level of Immersion after OFC(After each evaluation (approximately 1 week apart))
研究者
Sayantani B. Sindher
Clinical Associate Professor
Stanford University