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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-08

Study Completion Date

2023-01-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Anxiety Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Standard comfort given

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.

Virtual Reality (VR)

Group Type EXPERIMENTAL

Virtual Reality (VR)

Intervention Type DEVICE

The child who is undergoing a procedure uses VR as a distraction during the intervention

Interventions

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Control

This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.

Intervention Type BEHAVIORAL

Virtual Reality (VR)

The child who is undergoing a procedure uses VR as a distraction during the intervention

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No