Human Factors Analysis in VR for Burn Treatment

Study Overview
=================
Brief Summary
-----------------
A number of studies have shown that virtual reality (VR) can be used to distract patients from pain and anxiety during painful medical procedures for which medication provides inadequate relief. An inexpensive, commercially available VE could have significant impact in reducing perceived pain involved in a variety of medical procedures. The Virtual Reality Medical Center (VRMC) developed an engaging virtual world that proved to be effective in reducing reported pain ratings of participants experiencing several different forms of painful stimuli. The virtual world called Icy Cool World was found to successfully distract patients from painful stimuli and reduce patients' perceived levels of pain. Phase II looks to expand on these findings and examine the effectiveness as a pain distraction technique for a variety of acute and chronic pain etiologies. The main objective of the clinical investigation will be to expand on the findings from earlier studies and obtain a more comprehensive analysis regarding the clinical versatility of VR pain distraction.

Official Title
-----------------
Phase 1 and 2 Study of Human Factors Analysis in VR for Burn Treatment

Conditions
-----------------
Pain, Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality based distraction
* Behavioral: VR with flat projection display
* Behavioral: non-interactive video with head display
* Behavioral: non-interactive video with with flat projection display


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65, male or female, any ethnicity as long as candidates can understand and read English adequately. Exclusion Criteria: We will exclude participants who meet DSM-IV-TR criteria for alcohol or other substance abuse in the past year, or are currently using any recreational drugs, or taking more than 20 alcoholic drinks a week. In addition, the Beck Depression Inventory II (BDI-II) score must be less than 16, with no suicidal ideation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Virtual Reality with head display | Behavioral: Virtual Reality based distraction<br>* Participants will undergo virtual reality based distraction using the head display while they go through the pain process.<br>|
| Active Comparator: 2<br>Virtual Reality with flat projection display | Behavioral: VR with flat projection display<br>* VR with flat projection display<br>|
| Active Comparator: 3<br>non-interactive video with head display | Behavioral: non-interactive video with head display<br>* non-interactive video with head display<br>|
| Active Comparator: 4<br>non-interactive video with flat projection display | Behavioral: non-interactive video with with flat projection display<br>* non-interactive video with with flat projection display<br>|
| No Intervention: 5<br>No distraction | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain rating reduction |  | Following each trial |