Reducing Brief Thermal and Electrical Pain (Four Study Days)

NCT ID: NCT00682682

Last Updated: 2011-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-12-31

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

all study participants will have 4 visits: VR alone, VR + opioid, opioid alone, and no VR/opioid

Group Type: EXPERIMENTAL

Virtual Reality video distraction

Intervention Type: 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

Intervention Type: 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"

Interventions

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.

Intervention Type: 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"

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Chris Hoffer

Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel R. Sharar, MD

Role: PRINCIPAL_INVESTIGATOR

Professor, University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

030091D

Identifier Type: -

Identifier Source: org_study_id