Virtual Reality Water Friendly Wound Care

NCT ID: NCT02646787

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-06-30

Brief Summary

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

Detailed Description

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Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.The aim of this study is to conduct a randomized controlled trial of Virtual Reality as a means to reduce pain during wound care in patients hospitalized for their burn injuries at Harborview Medical Center Burn Center, and Shriners Hospitals for Children in Galveston, Texas.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Active Virtual Reality

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

Group Type EXPERIMENTAL

Active Virtual Reality

Intervention Type BEHAVIORAL

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

Passive Virtual Reality

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

Group Type EXPERIMENTAL

Passive Virtual Reality

Intervention Type BEHAVIORAL

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

Control

No intervention during the subject's standard wound care session

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active Virtual Reality

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

Intervention Type BEHAVIORAL

Passive Virtual Reality

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Texas

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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David Patterson

Professor, School of Medicine, Rehabilitation Medicine:Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David R Patterson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

David R Patterson, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington; Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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R01GM042725

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002594

Identifier Type: -

Identifier Source: org_study_id

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