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OpenTrials
Completed

NCT Number: NCT00993889

Virtual Reality Analgesia During Pediatric Physical Therapy

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).

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Key information

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104-2499, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR during Physical Therapy

Behavioral

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

VR Background Pain

Behavioral

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

NO VR

Behavioral

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.

Primary outcomes

  1. Pain and anxiety

    Time frame: pre and post procedure

Sponsors and collaborators

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Nih

Registry information

Acronym: VRD/Peds

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2009
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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