Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

Study Overview
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Brief Summary
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The goal of this study is to assess the utility of virtual reality technology to aid in the mental health of patients with cardiac disease, specifically looking at decreasing anxiety and perceptions of pain from stressful procedures in the pediatric electrophysiology laboratory.

Detailed Description
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The investigators will perform a pilot study of 40 patients who are randomized to either standard of care preparation for an electrophysiology procedure (control arm) vs. Virtual Reality preparation (VR arm). Participants in control arm will have standard preparation for a procedure including discussion of the procedure with the provider the day before the procedure with all questions answered at that time. VR arm participants will have access to the Virtual Reality tour and gear 1 week prior to the procedure. VR arm participants will be instructed to watch the Virtual Reality tour at least three times prior to the procedure but will be encouraged to watch as often as the participants would like. The Virtual Reality equipment will measure how often participants complete the tour. All participants will undergo anxiety measures a total of four times: once at time of recruitment, day of procedure and then 1 week and 4 weeks post procedure. Participants will have cortisol salivary swabs performed 1 week before procedure (before VR use), pre-op visit, day of procedure, and immediately following procedure. Heart rate and blood pressure will be measured on day of procedure.

Official Title
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Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

Conditions
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Stress, Psychological, Stress, Physiological, Anxiety, Pain Perception

Intervention / Treatment
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* Behavioral: Use of Virtual Reality App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric Cardiology patients between the age of 10 and 20 years old Undergoing cardiac electrophysiology procedure Exclusion Criteria: Inability to wear virtual reality glasses Patients under 10 years old Prior psychiatric illness

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>No research intervention to be administered. Participants will have standard preparation for a procedure including discussion of the procedure with the provider the day before the procedure with all questions answered at that time. | |
| Experimental: Virtual Reality<br>The VR interactive module will consist of a 360° visit to the Hospital where patients encounter the various aspects of a procedure from the front door; through the pre-operative area where patients will receive an IV; to the catheterization lab and placement of the anesthesia mask; and back to the post anesthesia care unit. Patients will be accompanied by a child who acts as a guide to the experience. The guide will help explain what the patient is seeing and what to expect along the way. Health care professionals will be enmeshed within the scenarios and will also help with the explanations along the way. Patients will be prompted to enter the relaxation scenarios at different stressful times along the tour to practice relaxation and mindfulness techniques (i.e. before IV start, or upon entering catheterization laboratory). Relaxation scenarios will include a snow scene, tropical beach or other guided imagery scenes. | Behavioral: Use of Virtual Reality App<br>* The VR app will consist of relaxation techniques as well as a virtual tour of the hospital (pre-op area, IV placement, cath lab, and post-op area).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety levels from baseline in patients as measured by the State Trait Anxiety Inventory (STAI). | State -Trait Anxiety Inventory (STAI) is a widely used self-report measure that estimates situational (state) and baseline (trait) anxiety in adults and children. It is both valid and reliable and routinely used in measuring anxiety associated with medical procedures. The pediatric version is available for use with upper elementary, or junior high or high school aged children. | At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety levels from baseline in patients as measured by Visual Analog Scale of Anxiety | Visual Analog Scale of Anxiety (VAS) is a widely used self-reported and observational measure of anxiety. Patients place a vertical line along a 10 cm horizontal line which is anchored with the descriptors not at all anxious and extremely anxious and 10 markings 1 cm apart. This simple format of assessing anxiety is often used in operating rooms or before medical procedures given its brevity and ease of administration is fast-paced settings. It has been correlated with STAI scores. | At time of recruitment, day of procedure | 
| Change in parent observation of child behavior from baseline as measured by Child Behavior Checklist (CBCL) | Child Behavior Checklist (CBCL) is a rating form of child behavior completed by parents. It has been developed for children aged 6-18 years. This checklist groups into sets of behaviors: internalizing, externalizing and total problems. | At time of recruitment and 4 weeks post procedure | 
| Change in anxiety levels from baseline in parents as measured by parental STAI | State -Trait Anxiety Inventory (STAI) is a widely used self-report measure that estimates situational (state) and baseline (trait) anxiety in adults and children. It is both valid and reliable and routinely used in measuring anxiety associated with medical procedures. | At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure | 
| Change in salivary cortisol levels from baseline in patients |  | 1 week before procedure (before use of VR), Day of pre-op, Day of procedure, Day after procedure or immediately after procedure if outpatient | 
| Heart rate in patients |  | Day of procedure | 
| blood pressure in patients |  | Day of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Stress Inoculation, Procedure