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Pain Control After Trauma (VRHTrauma)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00739076
First Posted: August 21, 2008
Last Update Posted: April 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
David Patterson, National Institute of General Medical Sciences (NIGMS)
  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 (Care Provider)
Primary Purpose: Treatment
Official Title: Pain Control After Trauma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain and Anxiety [ Time Frame: up to 3 times a day ]

Enrollment: 184
Study Start Date: August 2007
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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
Experimental: 3
Standard treatment.
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739076


Locations
United States, Washington
University of Washington; Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: David R Patterson, Ph.D University of Washington
  More Information

Responsible Party: David Patterson, PhD. ABPP. Professor, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00739076     History of Changes
Other Study ID Numbers: 30359-G
R01GM042725-09A1 ( U.S. NIH Grant/Contract )
First Submitted: August 20, 2008
First Posted: August 21, 2008
Last Update Posted: April 3, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Wounds and Injuries