The Use of AR / VR in Patients Presenting to the ED With Renal Colic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- 60 Minute Pain Level
研究概览
简要总结
Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients
详细描述
This study will randomize ED patients presenting for presumed renal colic to either standard pharmacologic pain management alone, or pharmacologic management plus use of an adjunct Virtual / Augmented reality calming application using an off-the-shelf VR/AR Headset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient self-reported history of nephrolithiasis
- •Subjective history suggesting that current presentation is similar to past presentations of nephrolithiasis (character, quality, location, intensity of pain; previous surgical intervention or lithotripsy)
- •Patients with self-reported moderate to severe pain on the visual pain scale determined as greater than 5/10
- •Normal vital signs (afebrile)
- •Agreeable to informed consent as dictated by IRB and local practice
- •No contraindications to standard therapy (ie fluids, NSAIDs, opioids, etc.)
- •Compliance with the virtual reality treatment
- •Keeps the headset on for the duration of the experience
- •Understands the instructions
排除标准
- •Age < 18 years
- •Individuals with chronic pain conditions such as fibromyalgia (chronic pain may confound results, as patients may have higher than baseline pain levels affecting their response to medications)
- •Individuals with severe anxiety or claustrophobia
- •Individuals with severe motion sickness or previous episodes of motion sickness due to VR (those who may not react well to the VR experience)
- •Individuals with GFR<60 or previous documented diagnosis of CKD as they may not be suitable candidate for traditional analgesia
- •Individuals with previous opioid dependence
- •Requirement of immediate surgery (obstructing calculi with concomitant urinary tract infection)
- •Patients with diagnoses meeting admission criteria (sepsis, MI)
- •Audio/visual impairment (unable to appreciate stimuli provided by the headset)
- •Patients administered opiates as the first line pain control medication will not be included in final data collection, as opioid administration may result in difficulty consenting and understanding the study protocol / design
研究组 & 干预措施
Standard of Care Pharmacologic Management
Patients receive standard of care pharmacologic management at the discretion of the treating provider
干预措施: Pharmacologic Standard of Care Alone (Other)
AR Adjunct Plus Standard of Care Pharmacologic Management
Patients receive adjunct AR Calming App via commercial AR/VR headset in addition to standard of care pharmacologic management at the discretion of the treating provider
干预措施: Commercial AR/VR Headset with Calming App (Device)
结局指标
主要结局
60 Minute Pain Level
时间窗: 60 minutes
Pain Level Change 60 minutes after enrollment, utilizing a 0-10 subjective score
次要结局
- 30 Minute Heart Rate(30 minutes)
- 30 Minute Pain Level(30 minutes)
- 30 Minute Blood Pressure(30 minutes)
- 60 Minute Heart Rate(60 Minutes)
- 60 Minute Blood Pressure(60 minutes)
- Rescue Intervention(24 Hours)
- Rescue Analgesia Use(4 hours)
研究者
Greg Neyman
Research Director
Community Medical Center, Toms River, NJ