Perioperative Virtual Reality for Pediatric Anesthesia

University of California, San Francisco71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anxiety

Interventions

Perioperative virtual reality headset with mobile appDEVICE

Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

UCSF Benioff Children's Hospital

San Francisco, California, United States

Outcomes

Primary Outcomes

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)

Time frame: (Day 0 + 15 minutes on average from initial baseline) On entering the OR

Perioperative Pediatric Anxiety (Change From Baseline)

Time frame: (Day 0 + 30 minutes on average from initial baseline) During mask induction

Secondary Outcomes

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.

Time frame: (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)

Time frame: (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.

Time frame: (Day 0 + 45 minutes on average from initial baseline) After mask induction

Data from ClinicalTrials.gov

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