Gurney Journey: Virtual Reality Distraction

March 7, 2024 updated by: Joseph Albietz, Children's Hospital Colorado

The Impact of Distraction During Transition to the Operating Room and Anesthesia Induction Using a Novel Virtual Reality Software Program on Pediatric Perioperative Anxiolysis and Induction Compliance.

The aim of this study is to determine whether a software virtual reality (VR) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. This study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. Compliance during anesthesia induction will also be monitored. Participants will be randomly placed into to one of two groups. Group 1 will receive standard care from a Certified Child Life Specialist prior to their surgery. Group 2 will receive standard care from a Certified Child Life Specialist and distraction with a novel virtual reality software program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to determine whether a novel software virtual reality (VR) program provided during transition from periop to the procedure room and anesthesia induction reduces preoperative anxiety, and induction compliance in pediatric patients. This study aims to specifically monitor and measure the anxiety of patients as they arrive at the preoperative suite, when parting from their parents for transportation to the procedure room, and at induction of anesthesia. Compliance during anesthesia induction will also be monitored. Participants will be randomized to one of two groups. Group 1 will receive standard care during their surgery. Group 2 will receive standard care and distraction with a novel virtual reality software program. We hypothesize that anxiety will be reduced, and anesthesia compliance will improve for participants in Group 2.

Study Type

Interventional

Enrollment (Estimated)

58

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 Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
        • Principal Investigator:
          • Joseph Albietz, MD
        • Sub-Investigator:
          • Jennifer Staab, MS

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages 5-17 years old.
  • Patients undergoing general anesthesia with mask induction for dental procedures.

Exclusion Criteria:

  • Cognitive impairment that will impact the use of the VR headset or interaction with the game.
  • Participants who cannot comfortably wear the VR headset.
  • Visual impairment that would hinder use of software program.
  • Patients receiving general anesthesia via IV.
  • Parent accompanies patient back for anesthesia induction.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Experimental
Standard CCLS care and distraction with Virtual Reality
Device: Standard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience)
Certified Child Life Specialist's will provide preparation and support for patients before and during their anesthesia induction for their dental procedure. Child life specialist's will utilize Gurney Journey as part of their support for induction. Gurney Journey is a mixed reality experience, using the Meta Quest 2 VR headset that was designed to mitigate patient anxiety during transport from pre-admission rooms to the procedure room/operating room for surgical procedures.
Active Comparator: Standard CCLS care
Behavioral: Standard Child Life Preparation and Support
Certified Child Life Specialist's will provide preparation and support for patients before and during their anesthesia induction for their dental procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction Compliance Checklist
Time Frame: In operating room at induction
Used to measure and observe a patient's compliance with anesthesia induction. It uses a checklist of 10 items that correspond to negative behaviors that are frequently observed at such time, scoring 1 point for each measure on the checklist. The score is obtained by summing the scores for all the items (10 points maximum). Perfect anesthetic induction (with no negative behaviors) scores 0 points, suboptimal induction is scored between 1 and 4 and a score above 4 is considered as poor induction.
In operating room at induction
modified Yale Preoperative Anxiety Scale
Time Frame: Perioperative, transport to operating room, in operating room
Observational scale used to measure patient anxiety at different time points. Higher scores mean the patient is displaying more anxiety. Scores range from 23.33 to 100.
Perioperative, transport to operating room, in operating room

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pediatric Behavioral Induction Assessment
Time Frame: After induction
Measure completed by anesthesiologist's in the procedure room to describe patients' behavior during induction of anesthesia.
After induction

Collaborators and Investigators

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

Sponsor

Children's Hospital Colorado

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-1183

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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