NCT03903510

Virtual Reality During Pediatric Cast Removal

A Randomized Control Trial of Virtual Reality to Reduce Anxiety During Pediatric Cast Removal

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Gillette Children's Specialty Healthcare · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Fractures, Bone

Interventions

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

Timeline

• Start date: 2019-05-21
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2019-04-04
• Last updated: 2021-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study