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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Inhalational Induction
• Intervention / Treatment: Other: Balloon game; Other: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jasmin YM Tong, FHKCA, FHKAM, FRCPC (Anes); Phone Number: +852 35133760; Email: tym651@ha.org.hk
• Study Contact Backup: Name: Vivian Yuen, FHKCA, FHKAM; Phone Number: +852 35133752; Email: yuenmyv@ha.org.hk

Study Locations

• China
  • Hong Kong, China
    • Hong Kong Children's Hospital
    • Contact: Vivian Yuen, FHKCA, FHKAM; Phone Number: +852 35133752; Email: yuenmyv@ha.org.hk
    • Contact: Jasmin YM Tong, FHKCA, FHKAM, FRCPC; Phone Number: +852 35133760; Email: tym651@ha.org.hk
    • Principal Investigator: Jasmin YM Tong, FHKCA, FHKAM, FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 3-5 years; patients of 3-5 years	Other: Balloon game; Interactive balloon game; Other: Control; Passive media
Other: 6-8 years; older children	Other: Balloon game; Interactive balloon game; Other: Control; Passive media

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical restraint	Yes or No	Perioperative/from anesthetic induction up to 15min
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; = 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.; = 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.; = 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.	Perioperative/from anesthetic induction up to 15min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Perioperative/from anesthetic induction up to 15min
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).	Within 24hrs after anesthetic induction, during PACU stay
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).	Within 24 hours after anesthetic induction, during PACU stay or, if the child remains sleepy, on the ward

Collaborators and Investigators

• Sponsor: Hong Kong Children's Hospital
• Investigators: Principal Investigator: Jasmin YM Tong, FHKCA, FHKAM, FRCPC, Hong Kong Children's Hospital

Publications and helpful links

General Publications

• Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25.
• Kain ZN, Mayes LC, Wang SM, Caramico LA, Hofstadter MB. Parental presence during induction of anesthesia versus sedative premedication: which intervention is more effective? Anesthesiology. 1998 Nov;89(5):1147-56; discussion 9A-10A. doi: 10.1097/00000542-199811000-00015.
• Rodriguez ST, Jang O, Hernandez JM, George AJ, Caruso TJ, Simons LE. Varying screen size for passive video distraction during induction of anesthesia in low-risk children: A pilot randomized controlled trial. Paediatr Anaesth. 2019 Jun;29(6):648-655. doi: 10.1111/pan.13636. Epub 2019 Apr 14.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 26, 2026

Study Record Updates

• Last Update Posted (Actual): August 31, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: physical restraint; Pediatric inhalational induction; mask acceptance; active engagement; passive media
• Other Study ID Numbers: Breatheballoon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No