Reducing Brief Thermal and Electrical Pain (Four Study Days)

NCT00682682 | Completed

• 1 other identifier: 030091D
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Keywords

Pain distraction; Analgesic interventions; Burn patients

Outcome Measures

Primary Outcomes (1)

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

  at completion of study

Study Arms (1)

1

EXPERIMENTAL

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

Other: Virtual Reality video distraction; Other: Virtual Reality video game

Interventions

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.

1

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"

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women 18-45 years old
• Normal height and weight ratio

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Samuel R. Sharar, MD

  Professor, University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: December 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 13, 2011

Record last verified: 2011-09

Locations

US (1)