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Virtual Reality During Pediatric Cast Removal

G

Gillette Children's

Status

Unknown

Conditions

Fractures, Bone

Treatments

Device: Virtual Reality (VR)

Study type

Interventional

Funder types

Other

Identifiers

NCT03903510
STUDY00005315

Details and patient eligibility

About

This study is a randomized control trial of Virtual Reality during cast removal procedures at a pediatric tertiary care center.

Full description

Cast removal is a common outpatient procedure and is a source of pain and anxiety for children. Children are often frightened by the appearance and the noise of the saw. Additionally, the saw blade can become warm, and this can be uncomfortable. Multiple methods have been used and studied to try to make this experience easier for children. These methods include: soft music, therapeutic play, and headphones. Virtual reality (VR) devices are now increasingly affordable and portable. VR could be a way to distract children from the appearance and sound of the procedure. VR has been used in other clinical settings to help patients with the anxiety associated with medical procedures. The investigators propose a randomized trial to assess the responses (e.g. questionnaires and monitors) of children to cast removal with VR versus the standard noise reduction headphones.

Enrollment

184 estimated patients

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Sustained a fracture in their arm/leg
  • No previous experience with a cast removal
  • Must have at least one wrist free of immobilization (for heart rate monitor)
  • Parents and patient are English speaking

Exclusion criteria

  • Patients with a history of epilepsy, ventricular shunt, motion sickness
  • Patients with any history of cognitive, visual or hearing impairment

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

184 participants in 2 patient groups

Virtual Reality
Experimental group
Description:
Participants will experience Virtual Reality during their cast removal
Treatment:
Device: Virtual Reality (VR)
Standard of care
No Intervention group
Description:
Participants will receive their usual standard of care treatment during cast removal

Trial contacts and locations

1

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Central trial contact

Christine K Santa Ana, BS; Andrew G Georgiadis, MD

Data sourced from clinicaltrials.gov

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