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.
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Colorado |
United States,
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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