Virtual Reality Analgesia During Pediatric Physical Therapy

National Institute of General Medical Sciences (NIGMS)1 site in 1 country18 target enrollmentMay 2009

ConditionsBurn

Overview

Phase: N/A
Intervention: Not specified
Conditions: Burn
Sponsor: National Institute of General Medical Sciences (NIGMS)
Enrollment: 18
Locations: 1
Primary Endpoint: Pain and anxiety
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

We would like to determine whether Virtual Reality (VR) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).

Detailed Description

This study is done in a hospital for inpatients pediatrics. By randomization some subjects will immersive Virtual Reality (VR) during a painful procedure on daily basis up to 10 days to see whether this will reduce the pain and anxiety.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

April 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Institute of General Medical Sciences (NIGMS)

Responsible Party

Principal Investigator

David R. Patterson

PhD.ABPP. Professor

National Institute of General Medical Sciences (NIGMS)

Eligibility Criteria

Inclusion Criteria

•Age greater than or equal to 8 years up to 20 yrs old
•Compliant and able to complete subject evaluation
•A minimum of 3 days of physical therapy, one physical therapy session per day
•No history of psychiatric (DSM-IV-R Axis I) or developmental disorder that would interfere with decisional capacity
•Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder that would interfere with decisional capacity
•Able to communicate verbally
•Able to take oral medications
•English-speaking

Exclusion Criteria

•- Age less than 8 years, or greater than 20 years.
•Not capable of indicating pain intensity
•Not capable of filling out study measures
•Hospitalization of fewer 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, if interfering with decisional capacity
•Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems that would interfere with decisional capacity
•Unable to communicate verbally
•Unable to take oral medications
•History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment that would interfere with treatment or decisional capacity