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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06283108
Other study ID # 23-1183
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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