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

Study Overview
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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.

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

Conditions
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Anxiety, Pain

Intervention / Treatment
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* Behavioral: Control
* Device: Virtual Reality (VR)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard comfort given | Behavioral: Control<br>* This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.<br>|
| Experimental: Virtual Reality (VR)<br> | Device: Virtual Reality (VR)<br>* The child who is undergoing a procedure uses VR as a distraction during the intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child pain score | Assessed by Wrong-Baker Children's Faces Pain Scale: The scale shows a series of faces ranging from a happy face at 0 which represents no hurt to a crying face at 10 which represents hurts worst. Based on the faces and descriptions, the patient chooses the face that best describes their level of pain. | Up to 24 hours following procedure | 
| Child anxiety (7 years old and older) | Assessed by State-Trait Anxiety Inventory for Children (STAIC): 20 questions with 3 answer options for each question. Scores range from 20 to 60 for state and 20 to 60 for trait with 60 being the higher (more or worse) anxiety on self-assessment. | Up to 24 hours following procedure | 
| Child anxiety (Younger than 7 years old) | Assessed by Children's Fear Scale: The Children's Fear Scale (CFS) is used to measure the anxiety or fear level of the children. The one-item scale consists of a row of five sex neutral faces ranging from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. | Up to 24 hours following procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental anxiety | Assessed by State-Trait Anxiety Inventory (STAI): a 20 question inventory where each question is on a Likert scale 1-4. The total range of the inventory is 20-80 with higher scores indicating more anxiety (please note that some questions are reverse coded). | Up to 24 hours following procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality