Pain Control After Trauma (VRHTrauma)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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: July 15, 2013
Last verified: July 2013
  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 ]

Estimated Enrollment: 200
Study Start Date: August 2007
Estimated Study Completion Date: December 2013
Primary Completion Date: June 2013 (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
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
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
Investigators
Principal Investigator: David R Patterson, Ph.D University of Washington
  More Information

No publications provided

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-C, R01GM042725-09A1
Study First Received: August 20, 2008
Last Updated: July 15, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014