Reducing Brief Thermal and Electrical Pain (Four Study Days) (4DO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00682682
Recruitment Status : Completed
First Posted : May 22, 2008
Last Update Posted : September 13, 2011
Information provided by (Responsible Party):
Chris Hoffer, University of Washington

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).

Condition or disease Intervention/treatment Phase
Pain Other: Virtual Reality video distraction Other: Virtual Reality video game Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reducing Brief Thermal and Electrical Pain (Four Study Days)
Study Start Date : December 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: 1
all study participants will have 4 visits: VR alone, VR + opioid, opioid alone, and no VR/opioid
Other: 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.

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"

Primary Outcome Measures :
  1. Efficacy of VR distraction with and without opioid when pain stimulus is applied. [ Time Frame: at completion of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00682682

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Principal Investigator: Samuel R. Sharar, MD Professor, University of Washington

Responsible Party: Chris Hoffer, Research Coordinator, University of Washington Identifier: NCT00682682     History of Changes
Other Study ID Numbers: 030091D
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Chris Hoffer, University of Washington:
Pain distraction
Analgesic interventions
Burn patients