MedPath

Gurney Journey: Virtual Reality Distraction

Not Applicable
Recruiting
Conditions
Dental Diseases
Dental Caries in Children
Interventions
Behavioral: Standard Child Life Preparation and Support
Device: Standard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience)
Registration Number
NCT06283108
Lead Sponsor
Children's Hospital Colorado
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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
58
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard CCLS careStandard Child Life Preparation and SupportStandard CCLS care
Virtual Reality ExperimentalStandard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience)Standard CCLS care and distraction with Virtual Reality
Primary Outcome Measures
NameTimeMethod
modified Yale Preoperative Anxiety ScalePerioperative, 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.

Induction Compliance ChecklistIn 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.

Secondary Outcome Measures
NameTimeMethod
The Pediatric Behavioral Induction AssessmentAfter induction

Measure completed by anesthesiologist's in the procedure room to describe patients' behavior during induction of anesthesia.

Trial Locations

Locations (1)

Children's Hospital Colorado

🇺🇸

Aurora, Colorado, United States

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