Virtual Reality Water Friendly Wound Care

Pain Clinical Trial

— H2OWC  

Official title:

Water Friendly Virtual Reality for Burns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646787
• Other study ID #: STUDY00002594
• Secondary ID: R01GM042725
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 2020

Study information

• Verified date: June 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.

Description:

Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.The aim of this study is to conduct a randomized controlled trial of Virtual Reality as a means to reduce pain during wound care in patients hospitalized for their burn injuries at Harborview Medical Center Burn Center, and Shriners Hospitals for Children in Galveston, Texas.

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 8 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 8 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

• Pain

Intervention

Behavioral:
• Active Virtual Reality
The subject is actively engaged in using virtual reality during a painful burn wound care session.
• Passive Virtual Reality
The subject is passively engaged in using virtual reality during a painful burn wound care session.

Locations

Country	Name	City	State
United States	University of Washington; Harborview Medical Center	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain. Pain is measured one time prior a painful burn wound care session, by asking the subjects about their pain level, using a questionnaire called graphic rating scale.		one time for the duration of one minute before the wound care
Primary	Pain. Pain is measured one time after a painful burn wound, by asking the subjects about their pain level, using a questionnaire called graphic rating scale.		one time for the duration of one minute after the wound care