H2O VR for Burns 2015

Pain Clinical Trial

— H2OWC  

Official title:

Water Friendly Virtual Reality for Burns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729259
• Other study ID #: 50416EB/002594
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 2020

Study information

• Verified date: June 2020
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to find additional methods to reduce pain during wound care. In this study the investigators use virtual reality (a form of distraction) in addition to pain medication during a burn wound care.

Description:

This study will employ a randomized within-subjects design. There are three different conditions in this study. By randomization, the participants will experience at least two of the conditions and likely all three, depending on the number of their wound care sessions. All subjects will always receive all their usual pain medications for all treatment conditions. The three conditions are: High Tech Virtual Reality (VRD), Low Tech Virtual Reality (Nature Slides), and standard wound care (no VR). The subjects will be randomly assigned to receive some portions of their wound care sessions during High Tech Virtual Reality (VRD), some portions during Low Tech Virtual Reality (Nature Slides), and some portions with standard wound care, no virtual reality. The treatment orders will be randomized. After each treatment condition the investigators will ask subjects one pain question about their pain intensity during the most recent treatment condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to 18 years

• Compliant and able to complete questionnaires

• No history of psychiatric disorder

• Not demonstrating delirium, psychosis or any form of Organic Brain Disorder

• Able to communicate verbally

• English-speaking

Exclusion Criteria:

• Age less than 18 years

• Not capable of indicating pain intensity

• Not capable of filling out study measures

• Evidence of traumatic brain injury

• History of psychiatric disorder

• Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems

• Unable to communicate orally

• Receiving prophylaxis for alcohol or drug withdrawal

• Developmental disability

• Any face/head/neck injuries that interfere with the use of Virtual Reality equipment

• Non-English Speaking

• Extreme susceptibility to motion sickness

• Seizure history

Related Conditions & MeSH terms

• Burn
• Burns
• Pain

Intervention

Behavioral:
• Virtual Reality Snowworld
The subjects will receive Virtual Reality Snowworld during their wound care procedure. The nurse will be doing their wound care.
• Virtual Reality slides of nature
The subjects will receive Virtual Reality Slides of Nature during their wound care procedure. The nurse will be doing their wound care.
• Control standard nurse wound care
The subjects will receive their standard care during wound care. The nurse will be doing the wound care.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of General Medical Sciences (NIGMS)	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Pain and anxiety" as measured by Graphic Rating Scale	Pain and anxiety is being measured	up to an hour