Clinical trial NCT06283108: Gurney Journey: Virtual Reality Distraction
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries in Children
Dental Diseases
Keywords: pediatric
induction
Lead sponsor: Children's Hospital Colorado
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 58
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Induction Compliance Checklist
timeFrame: In operating room at induction
measure: modified Yale Preoperative Anxiety Scale
timeFrame: Perioperative, transport to operating room, in operating room
Secondary outcomes:
measure: The Pediatric Behavioral Induction Assessment
timeFrame: After induction
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References: