Pain Control After Trauma

NCT ID: NCT00739076

Last Updated: 2015-04-03

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

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2014-12-31

Brief Summary

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Using Virtual Reality as a form of pain control for trauma patients.

Detailed Description

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The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' pain from trauma.

Conditions

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Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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1

Virtual Reality Hypnosis

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type BEHAVIORAL

Using Virtual Reality for pain control

2

Virtual Reality Distraction

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type BEHAVIORAL

Using Virtual Reality for pain control

3

Standard treatment.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type BEHAVIORAL

Using Virtual Reality for pain control

Interventions

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Virtual Reality

Using Virtual Reality for pain control

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 12 years
* Compliant and able to complete questionnaires
* Hospitalization for internal injuries requiring a laparotomy or for orthopedic injuries (closed long bone or calcaneus fractures).
* A minimum of 3 days hospitalization
* No history of psychiatric (DSM-IV-R Axis I) disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* Able to take oral medications
* Baseline pain level of \>=5/10
* English-speaking

Exclusion Criteria

* Age less than 12 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Hospitalization of less than 3 days
* Evidence of traumatic brain injury
* History of psychiatric (DSM-IV-R Axis I) disorder as evidenced in the admitting RN and MD admission notes.
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems.
* Unable to communicate orally.
* Unable to take oral medications
* History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Mini-mental status score of greater than 20 in patients older than 80 years or suspected of cognitive deficits
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history
Minimum Eligible Age

12 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 Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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David Patterson

PhD. ABPP. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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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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R01GM042725-09A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

30359-G

Identifier Type: -

Identifier Source: org_study_id

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