VRHTrauma: Pain Control After Trauma

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT00739076
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), National Institute of General Medical Sciences (NIGMS) (NIH)
• Enrollment: 184
• Location: 1
• Arms: 3
• Duration (Months): 88
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Using Virtual Reality as a form of pain control for trauma patients.

Condition or Disease	Intervention/Treatment	Phase
Trauma	Behavioral: Virtual Reality	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 184 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: Pain Control After Trauma
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Pain and Anxiety [up to 3 times a day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Patterson, PhD. ABPP. Professor, National Institute of General Medical Sciences (NIGMS)
• ClinicalTrials.gov Identifier: NCT00739076
• Other Study ID Numbers: 30359-G; R01GM042725-09A1
• First Posted: Aug 21, 2008
• Last Update Posted: Apr 3, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Apr 3, 2015