Pain Control After Trauma - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 20, 2008

Last Updated Date

August 20, 2008

Start Date ^†

August 2007

Current Primary Outcome Measures ^†

Pain and Anxiety [ Time Frame: up to 3 times a day ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Pain Control After Trauma

Official Title ^†

Pain Control After Trauma

Brief Summary

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

Detailed Description

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Caregiver), Parallel Assignment

Condition ^†

Trauma

Intervention ^†

Behavioral: Virtual Reality

Study Arms / Comparison Groups

Experimental: Virtual Reality Hypnosis
Experimental: Virtual Reality Distraction
No Intervention: Standard treatment with Virtual Reality Distraction at the end.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

200

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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 5 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
One surgery for trauma care with no additional anticipated inpatient surgeries
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 5 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
PCA administration of pain medication
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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739076

Responsible Party

David R. Patterson, PhD., University of Washington

Secondary IDs ^††

R01GM42725-09A1

Study Sponsor ^†

National Institutes of Health (NIH)

Collaborators ^††

Investigators ^†

Principal Investigator:

David R Patterson, Ph.D

University of Washington

Information Provided By

National Institute of General Medical Sciences (NIGMS)

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.