Pain Control After Trauma - Full Text View

Pain Control After Trauma (VRH Trauma)

This study is currently recruiting participants.
Verified by National Institute of General Medical Sciences (NIGMS), August 2008

Sponsored by:	National Institutes of Health (NIH)
Information provided by:	National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:	NCT00739076

Purpose

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

Condition	Intervention
Trauma	Behavioral: Virtual Reality

MedlinePlus related topics:

Injuries Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Caregiver), Parallel Assignment

Official Title:	Pain Control After Trauma

Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Virtual Reality Hypnosis	Behavioral: Virtual Reality Using Virtual Reality for pain control
2: Experimental Virtual Reality Distraction	Behavioral: Virtual Reality Using Virtual Reality for pain control
3: No Intervention Standard treatment with Virtual Reality Distraction at the end.	Behavioral: Virtual Reality Using Virtual Reality for pain control

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739076

Locations


United States, Washington
	University of Washington; Harborview Medical Center	Recruiting
	Seattle, Washington, United States, 98104
	Contact: David R. Patterson, Ph.D. 206-731-5443 davepatt@u.washington.edu
	Contact: Maryam Soltani, M.Ed 206-731-2172 soltani@u.washington.edu
	Principal Investigator: David R. Patterson, Ph.D.

Sponsors and Collaborators

National Institutes of Health (NIH)

Investigators


Principal Investigator:	David R Patterson, Ph.D	University of Washington

More Information

Responsible Party:	University of Washington ( David R. Patterson, PhD. )
Study ID Numbers:	30359, R01GM42725-09A1
First Received:	August 20, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00739076
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Wounds and Injuries

Disorders of Environmental Origin

Pain

ClinicalTrials.gov processed this record on October 15, 2008