Pain Control After Trauma

NCT00739076 | Completed

• 2 other identifiers: 30359-GR01GM042725-09A1
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

• Pain and Anxiety

  up to 3 times a day

Study Arms (3)

1

EXPERIMENTAL

Virtual Reality Hypnosis

Behavioral: Virtual Reality

2

EXPERIMENTAL

Virtual Reality Distraction

Behavioral: Virtual Reality

3

EXPERIMENTAL

Standard treatment.

Behavioral: Virtual Reality

Interventions

Virtual Reality BEHAVIORAL

Using Virtual Reality for pain control

1; 2; 3

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Washington; Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• David R Patterson, Ph.D

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. ABPP. Professor

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: August 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

US (1)