跳至主要内容
临床试验/NCT03894592
NCT03894592Unknown不适用

Utilizing Virtual Reality Analgesia (VRA) as a First Line Nonpharmacologic Analgesic Intervention on the Acute Rehabilitation Unit: A Pilot Study

New York City Health and Hospitals Corporation2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
54
试验地点
2
主要终点
Change in pain perception

研究概览

简要总结

This will be a pilot study utilizing Virtual Reality Analgesia (VRA) as a first line nonpharmacologic analgesic intervention on the Acute Rehabilitation Unit. In order to assess the efficacy of the intervention with a set of outcome measures will be defined:

  • Pain will be measured using the VAS for all subjects pre-, during and post-intervention via self-report.
  • Number of opioids/oral pain medication consumed will be analyzed
  • Patient anxiety will be measured on the Short ( State-Trait Anxiety Index) STAI anxiety scale pre- and post-intervention.
  • Heart rate and blood pressure will also be measured pre and post intervention.

详细描述

The purpose of this project is to evaluate the efficacy of virtual reality analgesia (VRA) for Adult patients in acute pain in the Acute Rehabilitation unit. Given the severity of the opioid epidemic, physicians are looking for alternative non-opioid/non-pharmacologic interventions to decrease both pain, and the need for opioids.

The recognition of pain by an individual requires both a noxious stimulus as well as attention on the part of the subject. Studies have shown that pain sensation is less on the visual analogue scale (VAS) when subjects are distracted, and that distraction can assist in pain control, since humans have limited attention capacity. When treating Adult patients with acute pain, it could thus be useful to have an effective method of pain distraction to improve tolerance and comfort, and to decrease the amount of narcotic medications prescribed.

Virtual reality (VR) is a digital simulation of a three-dimensional environment in which the user is capable of interacting with the generated world via computerized equipment such as gloves or a virtual reality head-mounted display (VRHMD). 360-degree VR video is a subset of virtual reality which creates an immersive experience of real world environments, allowing the user to have a sense of presence and exploration while wearing a (VRHMD). VR exposure is shown to be a potent distractor and has been repeatedly shown to provide analgesia during painful procedures. Since adults are often very attracted to technology, computer games, and virtual reality, we propose a study to allow adults to interact with a custom virtual reality environment in order to consume a substantial proportion of their attentional resources during acute pain episodes. We hypothesize that immersing the patients in VR will allow these patients to spend less attention on pain and allow for less need for other analgesia i.e. opioids.

VR has been demonstrated as a valid method of analgesia for both adults and pediatrics during painful procedures. To the investigator's knowledge, no one has evaluated the use of VRA to reduce opioid consumption in the Acute Rehab unit. In addition to relieving pain, anxiety, stress, and possibly decreasing general sedation, VRA may also decrease medical costs by decreasing length of stay.

Virtual Reality Analgesia (VRA) has been shown by research to be more effective when more immersive. To accomplish this, various head-sets and technologies have been developed to provide a more enveloping experience. Until recently, virtual reality head-mounted displays (VRHMD) had not been widely accepted due to their poor performance and high cost. But recent developments with the Oculus Rift DK1(DK 1 is a model number) in 2012 changed this paradigm. The now commercially available Oculus Rift is an inexpensive state of the art VRHMD. Using the Oculus Rift can create a high definition and smooth environment that will allow for maximal distraction at a modest price point. Therefore, equipment like the Oculus Rift could be an ideal VRA tool in the clinical setting.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Sequentially Numbered opaque sealed envelopes ( SNOSE) and an online randomization tool

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult with Traumatic injury on the Acute Rehab Unit
  • Adult ages 18-100
  • Adult with intact vision who can attend VR intervention
  • Adult receiving PO Medications
  • Adult with motor control of at least one arm

排除标准

  • Adult who has uncontrolled seizures more than 4 times per year
  • Adult who is not attentive to VR secondary to poor concentration/poor cognition to external stimuli.
  • Adult with no volitional control of the neck and or upper extremities.

研究组 & 干预措施

Virtual Reality analgesia

Active Comparator

Trauma patients in rehab unit in the participating hospital will be included in this arm if they are randomized to receive the intervention which is a virtual reality headset providing immersive interactive content in the video format

干预措施: Virtual reality (Other)

Control

No Intervention

Trauma patients in rehab unit in the participating hospital will be included in this arm if they are randomized to receive no intervention

结局指标

主要结局

Change in pain perception

时间窗: 1 year

will be measured using the Visual Analogue Scale (VAS) for all subjects pre-, during and post-intervention via self-report. The scale values range from 0 to 10. ) being no pain and 10 being the worst pain

次要结局

  • Heart Rate(1 year)
  • Patient reported anxiety(1 year)
  • Increase or decrease in opioid/oral pain medication use(1 year)
  • Blood Pressure(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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