Pain Control After Trauma

Trauma Clinical Trial

— VRHTrauma  

Official title:

Pain Control After Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739076
• Other study ID #: 30359-G
• Secondary ID: R01GM042725-09A1
• Status: Completed
• Phase: N/A
• First received: August 20, 2008
• Last updated: April 1, 2015
• Start date: August 2007
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Behavioral:
• Virtual Reality
Using Virtual Reality for pain control

Locations

Country	Name	City	State
United States	University of Washington; Harborview Medical Center	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and Anxiety		up to 3 times a day	No