Human Factors Analysis in VR for Burn Treatment

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409552
• Other study ID #: N44DA-5-7744
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 8, 2006
• Last updated: January 11, 2017
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Behavioral:
• Virtual Reality based distraction
Participants will undergo virtual reality based distraction using the head display while they go through the pain process.
• VR with flat projection display
VR with flat projection display
• non-interactive video with head display
non-interactive video with head display
• non-interactive video with with flat projection display
non-interactive video with with flat projection display

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain rating reduction		Following each trial	No