Pain Control After Trauma (VRHTrauma)
Primary Purpose
Trauma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
About this trial
This is an interventional treatment trial for Trauma
Eligibility 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
Sites / Locations
- University of Washington; Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Virtual Reality Hypnosis
Virtual Reality Distraction
Standard treatment.
Outcomes
Primary Outcome Measures
Pain and Anxiety
Secondary Outcome Measures
Full Information
NCT ID
NCT00739076
First Posted
August 20, 2008
Last Updated
April 1, 2015
Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT00739076
Brief Title
Pain Control After Trauma
Acronym
VRHTrauma
Official Title
Pain Control After Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of General Medical Sciences (NIGMS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Using Virtual Reality as a form of pain control for trauma patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Virtual Reality Hypnosis
Arm Title
2
Arm Type
Experimental
Arm Description
Virtual Reality Distraction
Arm Title
3
Arm Type
Experimental
Arm Description
Standard treatment.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality
Intervention Description
Using Virtual Reality for pain control
Primary Outcome Measure Information:
Title
Pain and Anxiety
Time Frame
up to 3 times a day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Patterson, Ph.D
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington; Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
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Pain Control After Trauma
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