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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

Page last updated: June 20, 2008

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