NCT02427659

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

5 years

First QC Date

March 31, 2015

Last Update Submit

March 11, 2019

Conditions

Keywords

VRDVirtual Reality as Distraction during ProcedureBurn Wound Care

Outcome Measures

Primary Outcomes (3)

  • "Pain" as measured by McGill Short Form Pain Questionnaire

    Pain is being measured

    up to an hour

  • "Pain" as measured by Nurse Graphic Rating Scale

    Pain is being measured.

    up to 3 hours

  • "Pain and anxiety" as measured by Graphic Rating Scale

    Pain and anxiety is being measured

    up to an hour

Study Arms (3)

Virtual Reality Distraction

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.

Behavioral: Virtual Reality Distraction

Audio (sounds of nature)

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.

Behavioral: Audio (sound of nature)

control standard nurse wound care

OTHER

The subjects will receive their standard care during wound care. The nurse will be doing the wound care.

Behavioral: Control standard nurse wound care

Interventions

The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.

Also known as: VRD
Virtual Reality Distraction

The subjects will listen to an audio recording called "Sounds of Nature" during their wound care.

Audio (sounds of nature)

The subjects will receive their standard care during wound care. The nurse will be doing the wound care.

control standard nurse wound care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington; Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

PainBurns

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • David R. Patterson, Ph.D.

    University fo Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 28, 2015

Study Start

November 1, 2011

Primary Completion

November 1, 2016

Study Completion

August 1, 2017

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations