NCT02729259

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

4.7 years

First QC Date

March 31, 2016

Last Update Submit

June 4, 2020

Conditions

Keywords

VRD

Outcome Measures

Primary Outcomes (1)

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

    Pain and anxiety is being measured

    up to an hour

Study Arms (3)

Virtual Reality Snowworld

OTHER

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

Behavioral: Virtual Reality Snowworld

Virtual Reality slides of nature

OTHER

The subjects will see several slides of the nature through virtual reality goggles during their wound care. The nurse will be doing the wound care.

Behavioral: Virtual Reality slides 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 Virtual Reality Snowworld during their wound care procedure. The nurse will be doing their wound care.

Virtual Reality Snowworld

The subjects will receive Virtual Reality Slides of Nature during their wound care procedure. The nurse will be doing their wound care.

Virtual Reality slides 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

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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)

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 of 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, 2016

First Posted

April 6, 2016

Study Start

October 1, 2015

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations