Human Factors Analysis in VR for Burn Treatment

Phase 1

Completed

• Conditions: Pain; Chronic Pain
• Interventions: 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

• Registration Number: NCT00409552
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-08
• Study First Submitted QC: 2006-12-08
• Study First Posted: 2006-12-11
• Status Verified: 2009-09
• Study Start: 2009-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Virtual Reality based distraction	Virtual Reality with head display
2	VR with flat projection display	Virtual Reality with flat projection display
3	non-interactive video with head display	non-interactive video with head display
4	non-interactive video with with flat projection display	non-interactive video with flat projection display

Primary Outcome Measures

Name	Time	Method
Pain rating reduction	Following each trial