Pain Control After Trauma (VRHTrauma)

This study has been completed.
Sponsor:
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)
ClinicalTrials.gov Identifier:
NCT00739076
First received: August 20, 2008
Last updated: April 1, 2015
Last verified: April 2015
  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:


Further study details as provided by University of Washington:

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

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

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 20, 2008
Last Updated: April 1, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 25, 2016