Human Factors Analysis in VR for Burn Treatment

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Pain; Pain

Treatments: Behavioral: non-interactive video with with flat projection display; Behavioral: non-interactive video with head display; Behavioral: Virtual Reality based distraction; Behavioral: VR with flat projection display

Study type: Interventional

Funder types: NIH

Identifiers

NCT00409552

N44DA-5-7744

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 5 patient groups

1

Experimental group

Description:

Virtual Reality with head display

Treatment:

Behavioral: Virtual Reality based distraction

2

Active Comparator group

Description:

Virtual Reality with flat projection display

Treatment:

Behavioral: VR with flat projection display

3

Active Comparator group

Description:

non-interactive video with head display

Treatment:

Behavioral: non-interactive video with head display

4

Active Comparator group

Description:

non-interactive video with flat projection display

Treatment:

Behavioral: non-interactive video with with flat projection display

5

No Intervention group

Description:

No distraction