Reducing Brief Thermal and Electrical Pain (Four Study Days) (4DO)
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|ClinicalTrials.gov Identifier: NCT00682682|
Recruitment Status : Completed
First Posted : May 22, 2008
Last Update Posted : September 13, 2011
Ultimately, the purpose of the present study is to help improve pain control in burn patients during wound care and physical therapy, where pain levels with opioids alone are often excessively high.
This study measures how much virtual reality pain distraction reduces pain compared to traditional opioid pain meds, and whether there is additional pain reduction when Virtual Reality distraction + Opioids are combined. In addition to studying the amount of pain reduction, this study will also measure side effects (if any) of the two treatments (Virtual Reality pain distraction and Opioids) alone and when combined.
Healthy volunteers will be recruited from advertisements will undergo a trial of the pain testing. They will receive a series of brief stimuli (at a painful but tolerable safe intensities they select and approve during baseline testing), separated by intervals of no pain.
Participants will rate how much pain they felt after each brief stimulus, and will fill out side effects questionnaires after finishing the pain session.
Subjects will participate in each of the four conditions in which the order is randomized.
- No opioids (0ng/ml hydromorphone) + no virtual reality Snow World distraction
- No opioids + yes virtual reality Snow World distraction
- Moderate dose of pain medicine (4ng/ml hydromorphone) + no virtual reality
- Moderate dose of pain medicine + yes virtual reality Snow World distraction
It is our hypothesis that VR distraction + opioids will show a reduced perception of pain in subjects more than opioids alone or no intervention (control).
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Virtual Reality video distraction Other: Virtual Reality video game||Not Applicable|
In this study, healthy volunteers aged 18-45 who sign up after seeing a flyer or web posting are screened for exclusion via telephone interview, and if eligible, a health background interview. Initial contact will come from the subject's response to recruitment materials. Subjects may withdraw at any time.
These safe laboratory studies with healthy volunteers are designed to help us figure out how to maximize the effectiveness of virtual reality when used with severe burn patients at Harborview Burn Center
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Reducing Brief Thermal and Electrical Pain (Four Study Days)|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||December 2008|
all study participants will have 4 visits: VR alone, VR + opioid, opioid alone, and no VR/opioid
Other: Virtual Reality video distraction
Virtual Reality involves wearing a helmet and playing a game called "Snow world". This game has sound and is presented in 3D format. This game has immersive qualities that help user feel as if they are "in" the game.
Other: Virtual Reality video game
Virtual Reality video games involve wearing a helmet with vision and sound. this game is presented in 3D which gives the user the feeling of being "in" the game. The game used for this study is "Snow World"
- Efficacy of VR distraction with and without opioid when pain stimulus is applied. [ Time Frame: at completion of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682682
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Samuel R. Sharar, MD||Professor, University of Washington|