Overview

This trial is active, not recruiting.

Conditions pain, burn
Treatments virtual reality distraction, audio (sound of nature), control standard nurse wound care
Sponsor National Institute of General Medical Sciences (NIGMS)
Start date November 2011
End date November 2016
Trial size 100 participants
Trial identifier NCT02427659, 41673

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (caregiver)
Arm
(Other)
The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
virtual reality distraction VRD
The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
(Other)
The subjects will listen to an audio recording called "Sounds of Nature" during their wound care. The nurse will be doing the wound care.
audio (sound of nature)
The subjects will listen to an audio recording called "Sounds of Nature" during their wound care.
(Other)
The subjects will receive their standard care during wound care. The nurse will be doing the 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.

Primary Outcomes

Measure
"Pain" as measured by McGill Short Form Pain Questionnaire
time frame: up to an hour
"Pain" as measured by Nurse Graphic Rating Scale
time frame: up to 3 hours
"Pain and anxiety" as measured by Graphic Rating Scale
time frame: up to an hour

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title High Technology Pain Control During Burn Wound Care
Principal investigator David R. Patterson, Ph.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by National Institute of General Medical Sciences (NIGMS).