Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Pain intensity as measured by the Visual Analog Scale
研究概览
简要总结
A three-group parallel randomized controlled trial to evaluate the efficacy of virtual reality analgesia (VRA) to decrease patient procedural pain and anxiety in the Adult patients undergoing Spinal Injections (SI).
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
- Double (Participant, Investigator)
盲法说明
The sealed envelope is randomized and blinded so no one will know which group the participant falls and its revealed only after the participant opens the sealed envelope.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult requiring Spinal Injections
- •Adult > 18years
- •Adults with intact vision who can attend VR intervention
排除标准
- •Anyone < 18 years
- •Adults who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli
- •Adults who request moderate IV sedation
- •Adults with photic-induced seizures
研究组 & 干预措施
Spinal Injection
Adults receiving Spinal Injection(SI) without Virtual Reality(VR).
干预措施: Lidocaine Hydrochloride (Drug)
Spinal Injection
Adults receiving Spinal Injection(SI) without Virtual Reality(VR).
干预措施: Bupivacaine (Drug)
Google Cardboard
Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
干预措施: Google Cardboard (Device)
Google Cardboard
Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
干预措施: Lidocaine Hydrochloride (Drug)
Google Cardboard
Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
干预措施: Bupivacaine (Drug)
Oculus
Adults receiving SI while using VR with Oculus Rift.
干预措施: Oculus (Device)
Oculus
Adults receiving SI while using VR with Oculus Rift.
干预措施: Lidocaine Hydrochloride (Drug)
Oculus
Adults receiving SI while using VR with Oculus Rift.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Pain intensity as measured by the Visual Analog Scale
时间窗: Immediately after receiving spinal injection
Participants are asked to rate their intensity of pain, by completing a Visual Analog Scale (VAS). The VAS consists of lines and emojis used to indicate pain level; the lines range from 0 (= no pain) to 10 (= unbearable pain) and the emojis range from 0 (= no pain) to 5 (= unbearable pain).
次要结局
- Anxiety Level as measured by the Visual Facial Anxiety Scale(Immediately after receiving spinal injection)
- Heart rate as measured by the Empatica E4 wristband(Baseline, during and Immediately after the procedure)
- Systolic Blood Pressure as measured by the Empatica E4 wristband(Baseline, during and Immediately after the procedure)
- Temperature as measured by the Empatica E4 wristband(Baseline, during and Immediately after the procedure)
- Diastolic Blood Pressure as measured by the Empatica E4 wristband(Baseline, during and Immediately after the procedure)
- Sympathetic skin response as measured by the Empatica E4 wristband(Baseline, during and Immediately after the procedure)
研究者
Sayed Wahezi
Principal Investigator
Albert Einstein College of Medicine