Reducing Brief Thermal and Electrical Pain (Four Study Days)

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).

Completed

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality video distraction

Other

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.

Virtual Reality video game

Other

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"

Primary outcomes

Efficacy of VR distraction with and without opioid when pain stimulus is applied.

Time frame: at completion of study

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Acronym: 4DO

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: May 22, 2008
Registry last updated: Sep 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed