Gurney Journey: Virtual Reality Distraction

Dental Caries in Children Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06283108
• Other study ID #: 23-1183
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Children's Hospital Colorado
• Contact: Claire Simonsen, BA
• Phone: 720-777-5313
• Email: claire.simonsen[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children
• Dental Diseases
• Stomatognathic Diseases

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	The Pediatric Behavioral Induction Assessment	Measure completed by anesthesiologist's in the procedure room to describe patients' behavior during induction of anesthesia.	After induction