NCT03583450

Perioperative Virtual Reality for Pediatric Anesthesia

Completed NA Results posted Last updated 8 July 2020

What this trial tests

NA trial testing Perioperative virtual reality headset with mobile app in Anxiety in 71 participants. Completed in 27 March 2019.

Timeline

29 August 2018

Primary endpoint
27 March 2019

27 March 2019

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	29 August 2018
Primary completion	27 March 2019
Estimated completion	27 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Perioperative virtual reality headset with mobile app

Conditions studied

• Anxiety — all drugs for Anxiety →

Sponsor

University of California, San Francisco

Who can join

Adults 5 to 12, any sex, with Anxiety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Perioperative Pediatric Anxiety (Change From Baseline) Primary · (Day 0 + 15 minutes on average from initial baseline) On entering the OR

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)

Group	Value	95% CI
Perioperative Virtual Reality Headset	0.0	0.0 – 0.0
Control	5.0	0.0 – 10.0

Perioperative Pediatric Anxiety (Change From Baseline) Primary · (Day 0 + 30 minutes on average from initial baseline) During mask induction

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)

Group	Value	95% CI
Perioperative Virtual Reality Headset	0.0	0.0 – 0.0
Control	13.3	5.0 – 26.7

Perioperative Parental Anxiety (Change From Baseline) Secondary · (Day 0 + 45 minutes on average from initial baseline) After mask induction

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.

Group	Value	95% CI
Perioperative Virtual Reality Headset	0	-3 – 3
Control	0	-3 – 3

Induction Compliance Checklist Secondary · (Day 0 + 30 minutes on average from initial baseline) During mask induction

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)

Group	Value	95% CI
Perioperative Virtual Reality Headset	0	0 – 0
Control	0	0 – 1

Parental Satisfaction Secondary · (Day 0 + 45 minutes on average from initial baseline) After mask induction

21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction.

Group	Value	95% CI
Perioperative Virtual Reality Headset	83	76 – 84
Control	80	76 – 83

Anesthesia Length Secondary · (Day 0 + 120 minutes on average from initial baseline) After exiting the OR

Length of time that patient received anesthesia care.

Group	Value	95% CI
Perioperative Virtual Reality Headset	80	± 91
Control	101	± 119

Surgery Length Secondary · (Day 0 + 120 minutes on average from initial baseline) After exiting the OR

Length of surgery from procedure start to procedure finish

Group	Value	95% CI
Perioperative Virtual Reality Headset	62	± 85
Control	77	± 106

Pre-medication Given Secondary · (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia

Whether patient was given anxiolytic medication prior to induction of general anesthesia

Group	Value	95% CI
Perioperative Virtual Reality Headset	0
Control	0
Perioperative Virtual Reality Headset	34
Control	37

Parent Present for Induction Secondary · (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia

Whether parent was present in operating room during induction of anesthesia

Group	Value	95% CI
Perioperative Virtual Reality Headset	30
Control	35
Perioperative Virtual Reality Headset	4
Control	2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial.
   Jung MJ, Libaw JS, Ma K, Whitlock EL, et al · · 2021 · cited 68× · PMID 32618627 · DOI 10.1213/ane.0000000000005004