Reducing Brief Thermal and Electrical Pain (Four Study Days)
Information source: University of Washington
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Virtual Reality video distraction (Other); Virtual Reality video game (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Samuel R. Sharar, MD, Principal Investigator, Affiliation: Professor, University of Washington
Summary
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).
Clinical Details
Official title: Reducing Brief Thermal and Electrical Pain (Four Study Days)
Study design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Efficacy of VR distraction with and without opioid when pain stimulus is applied.
Detailed description:
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
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy men and women 18-45 years old
- Normal height and weight ratio
Exclusion Criteria:
- women who are pregnant and nursing
- history of substance abuse
- access to opioids in the workplace
- smokes cigarettes
- history of medical problems with the following: heart, lungs, liver, kidneys,
endocrine, neurologic, migraines, or psychiatric requiring medical intervention
- anemia
- chronic pain
- allergy or hypersensitivity to opioids, velcro, or latex
- severe motion sickness
- unusual sensitivity or lack of sensitivity to pain
- sensitive skin or feet
Locations and Contacts
University of Washington, Seattle, Washington 98195, United States
Additional Information
Starting date: December 2007
Ending date: December 2008
Last updated: May 20, 2008
|
