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Reducing Brief Thermal and Electrical Pain (Four Study Days)

Reducing Brief Thermal and Electrical Pain (Four Study Days)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00682682
Acronym
4DO
Enrollment
20
Registered
2008-05-22
Start date
2007-12-31
Completion date
2008-12-31
Last updated
2011-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain distraction, Analgesic interventions, Burn patients

Brief 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).

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

Interventions

OTHERVirtual 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.

OTHERVirtual 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

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Efficacy of VR distraction with and without opioid when pain stimulus is applied.at completion of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026