Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures

University of Michigan

Status: Terminated

Conditions: Anxiety; Pain

Treatments: Behavioral: Control; Device: Virtual Reality (VR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05708586

HUM00197192

Details and patient eligibility

About

The purpose of this study is to demonstrate that the use of a virtual reality experience can decrease child and caregiver anxiety and pain for simple orthopaedic office procedures.

Enrollment: 66 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for pediatric patient:

• Undergoing cast removal, pin removal, or suture removal in study affiliated clinic
• Less than 17 years old

Exclusion Criteria for pediatric patient:

• History of seizures
• Pregnant, have preexisting binocular vision abnormalities or psychiatric disorders, or suffer from a heart condition or other serious medical condition
• Patients can't have implanted medical devices including cardiac pacemakers, hearing aids and defibrillators

There is no minimum or maximum age for the Caretakers/Parents.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Control

Active Comparator group

Description:

Standard comfort given

Treatment:

Behavioral: Control

Virtual Reality (VR)

Experimental group

Treatment:

Device: Virtual Reality (VR)