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.
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
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
Parallel
Balloon game
Other interventionInteractive balloon game
Control
Other interventionPassive media
Physical restraint
Yes or No
Degree of physical restraint
4 point pragmatic clinical scale: 0 = No restraint: The patient is cooperative or requires only verbal guidance; no physical holding is needed to apply the mask 1. = Mild restraint: Gentle holding of the child's hands or arms (usually by one person) to prevent interference with the mask, accompanied by minimal physical resistance from the child. 2. = Moderate restraint: Firm holding of the limbs and/or torso by one or two individuals due to active physical resistance or attempts to sit up. 3. = Severe restraint: Forceful holding of multiple body parts, including the head or full torso, often requiring multiple clinical staff and/or parents/legal guardians due to vigorous struggling, flailing, or combative behavior.
Induction compliance
Measured by the Induction Compliance Checklist (ICC) during mask application. The Induction Compliance Checklist (ICC) is an 11-item behavioral observation scale used to assess a child's reaction to the face mask during anesthesia induction. Each item corresponds to a specific mask-rejecting behavior, and the total score ranges from 0 to 10. A score of 0 indicates full cooperation with no mask-rejecting behavior, while a score of 10 represents the most severe rejection response. Higher ICC scores reflect greater resistance to the surgical mask during induction. Per the scale's originators, a total score of ≥6 is classified as indicating traumatic anesthesia induction.
Caregiver satisfaction and acceptability
Caregiver satisfaction and acceptability regarding the anesthetic induction will be assessed using a questionnaire comprising a series of statements, each rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Child self-reported acceptability
Patient satisfaction with the anesthetic induction will be assessed using an age-appropriate visual smiley-face scale, ranging from 1 (☹️, very unsatisfied) to 5 (?, very satisfied).The child's level of fear during the anesthetic induction will also be assessed using an age-appropriate visual smiley-face scale, ranging from 1 (?,, very scared) to 5 (?, very calm).
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