Virtual Reality Analgesia During Pediatric Physical Therapy

Not Applicable

Completed

• Conditions: Burn
• Interventions: Behavioral: VR during Physical Therapy; Behavioral: NO VR; Behavioral: VR Background Pain

• Registration Number: NCT00993889
• Lead Sponsor: National Institute of General Medical Sciences (NIGMS)

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR during Physical Therapy	VR during Physical Therapy	The subject will receive virtual reality during painful physical therapy sessions.
No VR	NO VR	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.
VR background pain	VR Background Pain	The subjects receives virtual reality, not during a physical therapy procedure, another time of the day for background pain.

Primary Outcome Measures

Name	Time	Method
Pain and anxiety	pre and post procedure

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States