Virtual Reality Analgesia In Trauma Rehab
Primary Purpose
Virtual Reality, Musculoskeletal Pain, Opioid Use
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Virtual Reality
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Jacobi Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Virtual Reality analgesia
Control
Arm Description
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
Trauma patients in rehab unit in the participating hospital will be included in this arm if they are randomized to receive no intervention
Outcomes
Primary Outcome Measures
Change in pain perception
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
Secondary Outcome Measures
Increase or decrease in opioid/oral pain medication use
Number of opioids/oral pain medication consumed will be analyzed from the patients electronic medical record
Heart Rate
Pre and post intervention heart rate will be monitored using regular hospital equipment to note any changes pre and post intervention.
Patient reported anxiety
Anxiety will be measured on the Short STAI (State-Trait Anxiety Index) anxiety scale pre- and post-intervention.
The scale has 2 parts with 20 questions in each part. Each question is rated on a 4 point scale,1 to 4.
Total scores range from 20 to 80 for each part, with higher score indicating higher anxiety
Blood Pressure
Pre and post intervention blood pressure will be monitored using regular hospital equipment to note any changes pre and post intervention.
Full Information
NCT ID
NCT03894592
First Posted
October 29, 2018
Last Updated
July 24, 2019
Sponsor
New York City Health and Hospitals Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03894592
Brief Title
Virtual Reality Analgesia In Trauma Rehab
Official Title
Utilizing Virtual Reality Analgesia (VRA) as a First Line Nonpharmacologic Analgesic Intervention on the Acute Rehabilitation Unit: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Anticipated)
Primary Completion Date
July 2, 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York City Health and Hospitals Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Musculoskeletal Pain, Opioid Use, Anxiety, Virtual Reality Analgesia, Trauma Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a Randomized control study. The pre and post VAS scores will be rated by the patient. Randomization will be achieved using Sequentially Numbered opaque sealed envelopes ( SNOSE) and an online randomization tool. All the patients will choose one of three virtual reality experiences.
Passive VR Movie
Interactive relaxation/exploration
Active/Adventure experience
Masking
InvestigatorOutcomes Assessor
Masking Description
Sequentially Numbered opaque sealed envelopes ( SNOSE) and an online randomization tool
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality analgesia
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Trauma patients in rehab unit in the participating hospital will be included in this arm if they are randomized to receive no intervention
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
Trauma patients enrolled in the study will be offered Virtual Reality experieince per the protocol
Primary Outcome Measure Information:
Title
Change in pain perception
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Increase or decrease in opioid/oral pain medication use
Description
Number of opioids/oral pain medication consumed will be analyzed from the patients electronic medical record
Time Frame
1 year
Title
Heart Rate
Description
Pre and post intervention heart rate will be monitored using regular hospital equipment to note any changes pre and post intervention.
Time Frame
1 year
Title
Patient reported anxiety
Description
Anxiety will be measured on the Short STAI (State-Trait Anxiety Index) anxiety scale pre- and post-intervention.
The scale has 2 parts with 20 questions in each part. Each question is rated on a 4 point scale,1 to 4.
Total scores range from 20 to 80 for each part, with higher score indicating higher anxiety
Time Frame
1 year
Title
Blood Pressure
Description
Pre and post intervention blood pressure will be monitored using regular hospital equipment to note any changes pre and post intervention.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Stern, MD
Phone
9175779543
Email
Michelle.Stern@nychhc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ratnakar P Veeramachaneni, MD
Phone
7182077551
Email
rveerama@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Stern, MD
Organizational Affiliation
New York City Health and Hospitals Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stern Michelle, MD
Phone
917-577-9543
Email
michelle.stern@nychhc.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality Analgesia In Trauma Rehab
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