Purpose

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

Condition

Eligibility

Eligible Ages
Between 4 Years and 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Virtual Reality
Participants will experience Virtual Reality during their cast removal
  • Device: Virtual Reality (VR)
    Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.
    Other names:
    • AppliedVR
No Intervention
Standard of care
Participants will receive their usual standard of care treatment during cast removal

Recruiting Locations

Gillette Children's Specialty Healthcare
Saint Paul, Minnesota 55101
Contact:
Andrew G Georgiadis, MD
651-602-3262
andrewgeorgiadis@gillettechildrens.com

More Details

NCT ID
NCT03903510
Status
Recruiting
Sponsor
Gillette Children's Specialty Healthcare

Study Contact

Andrew G Georgiadis, MD
651-602-3262
andrewgeorgiadis@gillettechildrens.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.