Gurney Journey: Virtual Reality Distraction

NCT06283108 | Completed FDA Device

• 1 other identifier: 23-1183
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries in Children; Dental Diseases; Gastrointestinal Surgery; Procedures Requiring Anesthesia

Keywords

pediatric; induction

Outcome Measures

Primary Outcomes (2)

• modified Yale Preoperative Anxiety Scale

  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

• Induction Compliance Checklist

  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

Secondary Outcomes (1)

• The Pediatric Behavioral Induction Assessment

  After induction

Study Arms (2)

Virtual Reality Experimental

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)

Standard CCLS care

ACTIVE COMPARATOR

Standard CCLS care

Behavioral: Standard Child Life Preparation and Support

Interventions

Standard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience) DEVICE

Certified Child Life Specialist's will provide preparation and support for patients before and during their anesthesia induction for their dental or gastrointestinal 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.

Virtual Reality Experimental

Standard Child Life Preparation and Support BEHAVIORAL

Certified Child Life Specialist's will provide preparation and support for patients before and during their anesthesia induction for their dental procedure.

Standard CCLS care

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Colorado: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Stomatognathic Diseases

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Critical Care

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 28, 2024
• Study Start: April 19, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)