Perioperative Virtual Reality for Pediatric Anesthesia

June 15, 2020 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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. 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

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Benioff Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perioperative virtual reality headset
Perioperative virtual reality headset with mobile app and routine anesthetic care
Device: Perioperative virtual reality headset with mobile app
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)
No Intervention: Control
Routine anesthetic care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Pediatric Anxiety (Change From Baseline)
Time Frame: (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)
(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
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)
Time Frame: (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.
(Day 0 + 45 minutes on average from initial baseline) After mask induction
Induction Compliance Checklist
Time Frame: (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)
(Day 0 + 30 minutes on average from initial baseline) During mask induction
Parental Satisfaction
Time Frame: (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.
(Day 0 + 45 minutes on average from initial baseline) After mask induction

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthesia Length
Time Frame: (Day 0 + 120 minutes on average from initial baseline) After exiting the OR
Length of time that patient received anesthesia care.
(Day 0 + 120 minutes on average from initial baseline) After exiting the OR
Surgery Length
Time Frame: (Day 0 + 120 minutes on average from initial baseline) After exiting the OR
Length of surgery from procedure start to procedure finish
(Day 0 + 120 minutes on average from initial baseline) After exiting the OR
Pre-medication Given
Time Frame: (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
(Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia
Parent Present for Induction
Time Frame: (Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia
Whether parent was present in operating room during induction of anesthesia
(Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Michael Jung, UCSF Medical Center
  • Principal Investigator: Jina Sinskey, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2018

Primary Completion (Actual)

March 27, 2019

Study Completion (Actual)

March 27, 2019

Study Registration Dates

First Submitted

June 18, 2018

First Submitted That Met QC Criteria

June 28, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-25277

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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