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.
Eligibility
Sex
ALL
Min age
3 Years
Max age
8 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Physical restraint — Perioperative/from anesthetic induction up to 15min Yes or No
Degree of physical restraint — Perioperative/from anesthetic induction up to 15min 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.
Trial sites (1)
Facility
City
Region
Status
Hong Kong Children's Hospital
Hong Kong
China
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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