NCT06111742

Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety

Audiovisual Interactive Games to Improve Pediatric Patient Cooperation With Induction of Anesthesia and Alleviate Perioperative Anxiety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Accepted

Summary

Pediatric anxiety upon induction of anesthesia is widely prevalent and can lead to negative patient psychological impact and hindrance to induction of anesthesia. Historically, premedication has been used as one means to improve pediatric preoperative anxiety and cooperation with induction. However, giving medication to children prior to surgery has drawbacks. Thus, other means have been proposed that may have similar benefits but fewer or different drawbacks. Recently, audiovisual distraction in the form of interactive games has been proposed. Such games have been in use at children's hospitals around the United States for more than five years. This study is a randomized trial that will explore using interactive games to improve pediatric perioperative anxiety in elective surgery compared with standard-of-care not including games. Perioperative anxiety with be evaluated using an observational scale.

Conditions

• Anxiety

Interventions

Type	Name	Description
DEVICE	Bedside Entertainment and Relaxation Theater (BERT)	BERT is a Nebula Capsule Max portable projector that creates a familiar theater experience designed for children to divert attention away from procedures. It is fitted with a remote control that can be utilized to manage on-screen activities. BERT can be used with any wall, ceiling, or projector screen to create the theater experience with a large screen. It can also be used with assist devices, such as steering wheel and noise-canceling headphones.

Timeline

• Start date: 2023-11-14
• Primary completion: 2024-02-12
• Completion: 2024-02-12
• First posted: 2023-11-01
• Last updated: 2025-05-08
• Results posted: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study