Virtual Reality During Pediatric Cast Removal

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
Gillette Children's Specialty Healthcare
Study ID
NCT03903510
Status
Recruiting
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Conditions

  • Fractures, Bone

Eligibility Criteria

Sex
ALL
Age
4 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Virtual Reality (VR) — DEVICE
    Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.

Study Details

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

Key Dates

Start date
May 21, 2019
Status verified
Feb 2021
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021

Study Design

Enrollment
184 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Virtual Reality
    Participants will experience Virtual Reality during their cast removal
  • No Intervention: Standard of care
    Participants will receive their usual standard of care treatment during cast removal

Primary Outcome Measure

Change from baseline heart rate during cast removal procedure [ Time Frame: Heart rate will be measured during the cast removal procedure. As this is a single visit study, heart rate will not be measured at any other time periods throughout the study. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Gillette Children's Specialty HealthcareSaint PaulMinnesota55101
Andrew G Georgiadis, MD
[email protected]
651-602-3262
Christine K Santa Ana, BS
[email protected]
651-229-1763
Andrew G Georgiadis, MD (PRINCIPAL_INVESTIGATOR)

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