Active Engagement Game Versus Passive Media During Pediatric Inhalational Induction

Active Engagement Game Versus Passive Media During Pediatric Inhalational Induction: A Pragmatic Randomized Trial

The goal of this clinical trial is to learn whether an active, breath-controlled iPad/phone game can reduce the need for physical restraint during mask-based anesthesia induction in children undergoing surgery.

The main question it aims to answer is:

Does an active-engagement game reduce the need for physical restraint during mask induction, compared with standard passive media distraction (such as watching cartoons)?

Investigators will compare children who use the new interactive game to children who receive standard passive audiovisual distraction, to see if the active game lowers rates of physical restraint during induction.

Participants will:

Play an interactive game on an iPad or phone while awake, before anesthesia begins, controlling it themselves.

Continue "playing" once the anesthesia mask is placed over their face, at which point the anesthesiologist takes over the controls using a phone remote.

Have the game synced to their own natural breathing pattern, so the visuals on the screen move in time with each breath, giving them a sense of active control without needing to physically touch the device.

Be compared to a group of children who instead watch passive video content (cartoons or similar) during induction, following standard care.

Preoperative anxiety is a highly prevalent complication in pediatric anesthesia, occurring in up to 50-60% of children undergoing surgery. High anxiety during the induction of anesthesia-particularly during the application of the face mask-is strongly correlated with poor induction compliance, increased risk of emergence delirium, higher postoperative analgesic requirements, and long-term negative behavioral changes.

To mitigate these risks, non-pharmacological behavioral interventions are widely integrated into routine pediatric perioperative care. While tablet-based audiovisual distraction (e.g., watching cartoons or playing games) has been shown to be a safe and effective alternative to pharmacological premedication, it is fundamentally limited by the physical realities of inhalational induction. Specifically, once the anesthesia mask is applied, children lose the physical ability to interact with standard digital games. Consequently, active distraction strategies frequently revert to passive observation at the exact moment when the child experiences the highest sensory distress.

Emerging evidence suggests that active cognitive engagement is superior to passive observation for sustained anxiolysis. However, there is a lack of specialized active distraction tools that safely integrate with the hands-on airway management workflow of the anesthesiologist. To address this gap, the investigators developed a novel, two-phase interactive iPad/phone game. During the awake pre-induction phase, the child interacts directly with the screen. As the anesthesia mask is applied, control of the game seamlessly transfers to a phone remote operated by the anesthesiologist. The anesthesiologist synchronizes the remote to the child's spontaneous respiratory rate, providing the child with active, breath-driven visual feedback on the iPad/phone screen without requiring their physical interaction.

The primary objective of this pragmatic randomized controlled trial is to determine whether this breath-synchronized active engagement game reduces the need for physical restraint during pediatric mask induction compared to standard passive media distraction.

Inclusion Criteria:

• Age 3 to 8 years
• American Society of Anesthesiologists (ASA) physical status I or II
• Elective surgery or sedation requiring general anesthesia
• Planned mask (inhalational) induction
• Assessed by the attending anesthesiologist as sufficiently calm and cooperative to participate without pharmacological premedication for anxiolysis

Exclusion Criteria:

• Receipt of pharmacological premedication for anxiolysis (e.g., intranasal dexmedetomidine, oral midazolam)
• Developmental, cognitive, or communication impairment severe enough to preclude engagement with the interactive game or understanding of instructions
• Profound visual or hearing impairment that would prevent participation in the game or usual care distraction
• Any clinical airway scenario in which the attending anesthesiologist determines that study participation poses a safety risk