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Pain Control After Trauma (VRHTrauma)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Institute of General Medical Sciences (NIGMS).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00739076
First received: August 20, 2008
Last updated: April 7, 2010
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention
Trauma
 Behavioral: Virtual Reality

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Pain Control After Trauma

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1
Virtual Reality Hypnosis
 Behavioral: Virtual Reality
Using Virtual Reality for pain control
Experimental: 2
Virtual Reality Distraction
 Behavioral: Virtual Reality
Using Virtual Reality for pain control
No Intervention: 3
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.     206-744-5443     davepatt@u.washington.edu    
Contact: Maryam Soltani, M.Ed     206-744-2172     soltani@u.washington.edu    
Principal Investigator: David R. Patterson, Ph.D.            
Sponsors and Collaborators
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: David R Patterson, Ph.D University of Washington
  More Information

No publications provided

Responsible Party: David R. Patterson, PhD., University of Washington
ClinicalTrials.gov Identifier: NCT00739076     History of Changes
Other Study ID Numbers: 30359-C, R01GM042725-09A1
Study First Received: August 20, 2008
Last Updated: April 7, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013