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OpenTrials
Completed

NCT Number: NCT00409552

Human Factors Analysis in VR for Burn Treatment

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality based distraction

Behavioral

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

VR with flat projection display

Behavioral

VR with flat projection display

non-interactive video with head display

Behavioral

non-interactive video with head display

non-interactive video with with flat projection display

Behavioral

non-interactive video with with flat projection display

Primary outcomes

  1. Pain rating reduction

    Time frame: Following each trial

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2006
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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