Virtual Reality Analgesia During Pediatric Physical Therapy (VRD/Peds)

National Institute of General Medical Sciences (NIGMS)

Status: Completed

Conditions: Burn

Treatments: Behavioral: VR Background Pain; Behavioral: VR during Physical Therapy; Behavioral: NO VR

Study type: Interventional

Funder types: NIH

Identifiers

NCT00993889

36154-C

Details and patient eligibility

About

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).

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 5 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 3 patient groups

VR during Physical Therapy

Experimental group

Description:

The subject will receive virtual reality during painful physical therapy sessions.

Treatment:

Behavioral: VR during Physical Therapy

VR background pain

Experimental group

Description:

The subjects receives virtual reality, not during a physical therapy procedure, another time of the day for background pain.

Treatment:

Behavioral: VR Background Pain

No VR

Experimental group

Description:

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.

Treatment:

Behavioral: NO VR