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Pain Control After Trauma (VRHTrauma)

Primary Purpose

Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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)
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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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