Status:
COMPLETED
Virtual Reality Analgesia During Pediatric Physical Therapy
Lead Sponsor:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Burn
Eligibility:
All Genders
5-20 years
Phase:
NA
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 exp...
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 th...
Eligibility Criteria
Inclusion
- 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
- \- 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
- Receiving prophylaxis for alcohol or drug withdrawal
- Developmental disability that would interfere with decisional capacity
- Face/head/neck injuries preventing helmet use
- Non-English-speaking
- Extreme susceptibility to motion sickness
- Seizure history
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00993889
Start Date
May 1 2009
End Date
April 1 2017
Last Update
March 13 2019
Active Locations (1)
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1
Harborview Medical Center
Seattle, Washington, United States, 98104-2499