Human Factors Analysis in VR for Burn Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Virtual Reality with head display

Group Type EXPERIMENTAL

Virtual Reality based distraction

Intervention Type BEHAVIORAL

Participants will undergo virtual reality based distraction using the head display while they go through the pain process.

2

Virtual Reality with flat projection display

Group Type ACTIVE_COMPARATOR

VR with flat projection display

Intervention Type BEHAVIORAL

VR with flat projection display

3

non-interactive video with head display

Group Type ACTIVE_COMPARATOR

non-interactive video with head display

Intervention Type BEHAVIORAL

non-interactive video with head display

4

non-interactive video with flat projection display

Group Type ACTIVE_COMPARATOR

non-interactive video with with flat projection display

Intervention Type BEHAVIORAL

non-interactive video with with flat projection display

5

No distraction

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality based distraction

Participants will undergo virtual reality based distraction using the head display while they go through the pain process.

Intervention Type BEHAVIORAL

VR with flat projection display

Intervention Type BEHAVIORAL

non-interactive video with head display

Intervention Type BEHAVIORAL

non-interactive video with with flat projection display

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No