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Virtual Reality Analgesia During Pediatric Physical Therapy

Virtual Reality Analgesia During Pediatric Physical Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00993889
Acronym
VRD/Peds
Enrollment
18
Registered
2009-10-14
Start date
2009-05-31
Completion date
2017-04-30
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn

Keywords

Virtual Reality Peds

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.

Interventions

BEHAVIORALVR during Physical Therapy

Virtual Reality will be performed during a painful physical therapy procedure.

BEHAVIORALVR Background Pain

Virtual Reality is used at anytime during the day for the background pain, not during physical therapy.

BEHAVIORALNO 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.

Sponsors

National Institute of General Medical Sciences (NIGMS)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
5 Years to 20 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain and anxietypre and post procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026