NCT02646787

Brief Summary

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

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
4.4 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

December 15, 2015

Last Update Submit

June 4, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Active Virtual Reality

EXPERIMENTAL

The subject is actively engaged in using virtual reality during a painful burn wound care session.

Behavioral: Active Virtual Reality

Passive Virtual Reality

EXPERIMENTAL

The subject is passively engaged in using virtual reality during a painful burn wound care session.

Behavioral: Passive Virtual Reality

Control

NO INTERVENTION

No intervention during the subject's standard wound care session

Interventions

The subject is actively engaged in using virtual reality during a painful burn wound care session.

Active Virtual Reality

The subject is passively engaged in using virtual reality during a painful burn wound care session.

Passive Virtual Reality

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 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

You may not qualify if:

  • 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

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

Pain

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David R Patterson, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR
  • 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
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine, Rehabilitation Medicine:Psychology

Study Record Dates

First Submitted

December 15, 2015

First Posted

January 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

Locations