Reducing Brief Thermal and Electrical Pain (Four Study Days)

Pain Clinical Trial

— 4DO  

Official title:

Reducing Brief Thermal and Electrical Pain (Four Study Days)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682682
• Other study ID #: 030091D
• Status: Completed
• Phase: N/A
• First received: May 20, 2008
• Last updated: September 12, 2011
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: September 2011
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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"

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of VR distraction with and without opioid when pain stimulus is applied.		at completion of study	No