Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI) (VR adult)
2021年1月12日 更新者：Sayed Wahezi、Albert Einstein College of Medicine
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).
研究概览
研究类型
介入性
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult requiring Spinal Injections
- Adult > 18years
- Adults with intact vision who can attend VR intervention
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Spinal Injection
Adults receiving Spinal Injection(SI) without Virtual Reality(VR).
|
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
|
|
有源比较器：Google Cardboard
Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
|
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI).
VRA is a the oculus or the google cardboard that helps decrease anxiety.
The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.
|
|
有源比较器：Oculus
Adults receiving SI while using VR with Oculus Rift.
|
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI).
VRA is a the oculus or the google cardboard that helps decrease anxiety.
The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain intensity as measured by the Visual Analog Scale
大体时间：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).
|
Immediately after receiving spinal injection
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anxiety Level as measured by the Visual Facial Anxiety Scale
大体时间：Immediately after receiving spinal injection
|
Participants are asked to rate their anxiety level by completing the Visual Facial Anxiety Scale(VFAS).
The VFAS consists of emojis ranging from 0 (= no anxiety) to 5 (highest anxiety).
|
Immediately after receiving spinal injection
|
|
Heart rate as measured by the Empatica E4 wristband
大体时间：Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure heart rate before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
|
Systolic Blood Pressure as measured by the Empatica E4 wristband
大体时间：Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
|
Diastolic Blood Pressure as measured by the Empatica E4 wristband
大体时间：Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
|
Sympathetic skin response as measured by the Empatica E4 wristband
大体时间：Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Sympathetic skin response before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
|
Temperature as measured by the Empatica E4 wristband
大体时间：Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Temperature before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Sayed Wahezi, MD、Albert Einstein College Of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年11月30日
初级完成 (预期的)
2020年12月1日
研究完成 (预期的)
2020年12月1日
研究注册日期
首次提交
2018年12月5日
首先提交符合 QC 标准的
2018年12月21日
首次发布 (实际的)
2018年12月26日
研究记录更新
最后更新发布 (实际的)
2021年1月14日
上次提交的符合 QC 标准的更新
2021年1月12日
最后验证
2021年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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