VR High Tech Pain Control Burn Wound Care

Pain Clinical Trial

— VRH2O  

Official title:

High Technology Pain Control During Burn Wound Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427659
• Other study ID #: 41673
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: August 2017

Study information

• Verified date: March 2019
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using virtual reality as a form of distraction for pain during wound care. Virtual reality involves looking into a set of goggles and then moving through a computer-simulated world.

Description:

This study has three different groups. Patients will be randomly assigned to one of three groups (two treatments and one control). Treatment for Group 1 is Virtual Reality Distraction during wound care. Group 2 will listen to an audio recording called "Sounds of Nature". Group 3 will be the control group.

Subjects in all three groups will receive the following questionnaires:

Graphic Rating Scale McGill Short-Form pain questionnaire Sullivan Catastrophization scale (only on Day 1/Baseline) The Nurse GRS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 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 Distraction
The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
• Audio (sound of nature)
The subjects will listen to an audio recording called "Sounds of Nature" during 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	University of Washington; Harborview Medical Center	Seattle	Washington

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Pain" as measured by McGill Short Form Pain Questionnaire	Pain is being measured	up to an hour
Primary	"Pain" as measured by Nurse Graphic Rating Scale	Pain is being measured.	up to 3 hours
Primary	"Pain and anxiety" as measured by Graphic Rating Scale	Pain and anxiety is being measured	up to an hour