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Human Factors Analysis in VR for Burn Treatment

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00409552
Enrollment
10
Registered
2006-12-11
Start date
2009-11-30
Completion date
2010-12-31
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Pain

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.

Interventions

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

BEHAVIORALVR with flat projection display

VR with flat projection display

BEHAVIORALnon-interactive video with head display

non-interactive video with head display

BEHAVIORALnon-interactive video with with flat projection display

non-interactive video with with flat projection display

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pain rating reductionFollowing each trial

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026