Dental Caries in Children, Dental Diseases, Gastrointestinal Surgery, Procedures Requiring Anesthesia
Conditions
Keywords
pediatric, induction
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.
Interventions
DEVICEStandard 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 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.
BEHAVIORALStandard 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.
Sponsors
Children's Hospital Colorado
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 5-17 years old. * Patients undergoing general anesthesia with mask induction for dental or gastrointestinal 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified Yale Preoperative Anxiety Scale | 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. |
| Induction Compliance Checklist | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Pediatric Behavioral Induction Assessment | After induction | Measure completed by anesthesiologist's in the procedure room to describe patients' behavior during induction of anesthesia. |
Countries
United States
Outcome results
None listed