Perioperative Virtual Reality for Pediatric Anesthesia

Study Overview
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Brief Summary
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The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.

Detailed Description
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The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial. We will be enrolling patients age 5-12 years presenting for elective surgery. Patients will be randomized to one of two groups: (1) virtual reality headset with routine anesthetic care and (2) routine anesthetic care only.

Official Title
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Perioperative Virtual Reality for Pediatric Anesthesia: Pediatric Distraction on Induction With Virtual Reality (PEDI-VR)

Conditions
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Anxiety

Intervention / Treatment
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* Device: Perioperative virtual reality headset with mobile app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 5-12 years Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure Exclusion Criteria: Patients with injuries to the head/face that would prohibit wearing of headsets Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face Patients with a history of or current symptoms of vertigo Patients who are blind Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver Patients on whom the VR headset does not fit appropriately Non-English speaking patients (due to limited availability of non-English study documents and consents)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Perioperative virtual reality headset<br>Perioperative virtual reality headset with mobile app and routine anesthetic care | Device: Perioperative virtual reality headset with mobile app<br>* Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)<br>|
| No Intervention: Control<br>Routine anesthetic care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Pediatric Anxiety (Change From Baseline) | Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety) | (Day 0 + 15 minutes on average from initial baseline) On entering the OR | 
| Perioperative Pediatric Anxiety (Change From Baseline) | Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety) | (Day 0 + 30 minutes on average from initial baseline) During mask induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Parental Anxiety (Change From Baseline) | State-Trait Anxiety Inventory: Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety. Total range 20 to 80 with higher scores indicating greater anxiety. The value is a sum of trait and state anxiety. | (Day 0 + 45 minutes on average from initial baseline) After mask induction | 
| Induction Compliance Checklist | Induction Compliance Checklist (An observational scale used to describe the compliance of a child during induction of anesthesia, range 0 to 11 with higher scores indicating less compliance) | (Day 0 + 30 minutes on average from initial baseline) During mask induction | 
| Parental Satisfaction | 21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction. | (Day 0 + 45 minutes on average from initial baseline) After mask induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Pediatric Anesthesia