Virtual Reality Analgesia During Pediatric Physical Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Reality Analgesia During Pediatric Physical Therapy

Conditions
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Burn

Intervention / Treatment
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* Behavioral: VR during Physical Therapy
* Behavioral: VR Background Pain
* Behavioral: NO VR


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR during Physical Therapy<br>The subject will receive virtual reality during painful physical therapy sessions. | Behavioral: VR during Physical Therapy<br>* Virtual Reality will be performed during a painful physical therapy procedure.<br>|
| Experimental: VR background pain<br>The subjects receives virtual reality, not during a physical therapy procedure, another time of the day for background pain. | Behavioral: VR Background Pain<br>* Virtual Reality is used at anytime during the day for the background pain, not during physical therapy.<br>|
| Experimental: No VR<br>The subject will receive the usual standard treatment. At the end of the study, before being discharged from the hospital, the subject can experience the VR, not during a procedure. | Behavioral: NO VR<br>* The subject will receive the usual standard treatment. At the end of the study, before being discharged from the hospital, the subject can experience the VR, not during a procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and anxiety |  | pre and post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality Peds