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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chris Hoffer, University of Washington
ClinicalTrials.gov Identifier:
NCT00682682
First received: May 20, 2008
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
Pain
 Other: Virtual Reality video distraction
Other: Virtual Reality video game

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Reducing Brief Thermal and Electrical Pain (Four Study Days)

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Efficacy of VR distraction with and without opioid when pain stimulus is applied. [ Time Frame: at completion of study ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682682

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

No publications provided

Responsible Party: Chris Hoffer, Research Coordinator, University of Washington
ClinicalTrials.gov Identifier: NCT00682682     History of Changes
Other Study ID Numbers: 030091D
Study First Received: May 20, 2008
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013