Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-03-13 @ 12:17 PM
Study NCT ID:
NCT03894592
Status:
UNKNOWN
Last Update Posted:
2019-07-26
First Post:
2018-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Analgesia In Trauma Rehab
Sponsor:
New York City Health and Hospitals Corporation
Organization:
Study Overview
Official Title:
Utilizing Virtual Reality Analgesia (VRA) as a First Line Nonpharmacologic Analgesic Intervention on the Acute Rehabilitation Unit: A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
* 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.
Detailed Description:
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.
Many corporations such as Samsung, Google, and others have invested both capital and development resources that have advanced virtual reality technologies and made them very inexpensive. With these changes, the investigators are finally at a point where both the hardware and the software needed to produce high quality VRHMD is now available at very low and moderate price points. An example of the lowest cost VRHMD is the Google Cardboard, a simple device that allows anyone with a cellphone to experience VR, for as little as $15.
The investigators propose a study utilizing the highest quality VRHMD to provide VRA during acute pain related to trauma. It is the investigators' hypothesis that by using VRA, significant decrease in the overall pain and discomfort can be observed resulting in a decrease in consumption of oral 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.
Many corporations such as Samsung, Google, and others have invested both capital and development resources that have advanced virtual reality technologies and made them very inexpensive. With these changes, the investigators are finally at a point where both the hardware and the software needed to produce high quality VRHMD is now available at very low and moderate price points. An example of the lowest cost VRHMD is the Google Cardboard, a simple device that allows anyone with a cellphone to experience VR, for as little as $15.
The investigators propose a study utilizing the highest quality VRHMD to provide VRA during acute pain related to trauma. It is the investigators' hypothesis that by using VRA, significant decrease in the overall pain and discomfort can be observed resulting in a decrease in consumption of oral opioids.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: