Recruiting

Virtual Reality

Sponsor:

Gillette Children's Specialty Healthcare

Code:

NCT03903510

Conditions

Fractures, Bone

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Interventions

Virtual Reality (VR)

Study Details

Brief summary:

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

Conditions

Fractures, Bone

Study ID

NCT03903510

Start date

May 21, 2019

Status verified date

Feb, 2021

Completion date

Sep, 2021

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

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

Enrollment

184 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

Virtual Reality (VR)

Participants in the experimental group will receive an AppliedVR virtual reality headset during their 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 and Locations

Central contacts

Andrew G Georgiadis, MD

651-602-3262andrewgeorgiadis@gillettechildrens.com

Christine K Santa Ana, BS

651-229-1763ChristineKSantaAna@gillettechildrens.com

Locations

Gillette Children's Specialty Healthcare

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Andrew G Georgiadis, MD

651-602-3262andrewgeorgiadis@gillettechildrens.com

Christine K Santa Ana, BS

651-229-1763ChristineKSantaAna@gillettechildrens.com

Principal Investigator:

Andrew G Georgiadis, MD

More Information

Sponsor

Gillette Children's Specialty Healthcare

Last update posted

Feb 11, 2021

Last verified

Feb, 2021

Keywords

  • Virtual Reality
  • Cast removal
  • Fracture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gillette Children's Specialty Healthcare on 2021-02-11.