Active Engagement Game Versus Passive Media During Pediatric Inhalational Induction

NCT07787351 | Not Yet Recruiting

• 1 other identifier: Breatheballoon
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Inhalational Induction

Keywords

Pediatric inhalational induction; mask acceptance; active engagement; passive media; physical restraint

Outcome Measures

Primary Outcomes (2)

• 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 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.

  Perioperative/from anesthetic induction up to 15min

Secondary Outcomes (3)

• Induction compliance

  Perioperative/from anesthetic induction up to 15min

• Caregiver satisfaction and acceptability

  Within 24hrs after anesthetic induction, during PACU stay

• Child self-reported acceptability

  Within 24 hours after anesthetic induction, during PACU stay or, if the child remains sleepy, on the ward

Study Arms (2)

3-5 years

OTHER

patients of 3-5 years

Other: Balloon game; Other: Control

6-8 years

OTHER

older children

Other: Balloon game; Other: Control

Interventions

Balloon game OTHER

Interactive balloon game

3-5 years; 6-8 years

Control OTHER

Passive media

3-5 years; 6-8 years

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Children's Hospital: lead

Study Sites (1)

Hong Kong Children's Hospital

Hong Kong, China

Location

Related Publications (3)

• 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.

  PMID: 23011563 BACKGROUND

• 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.

  PMID: 30916447 BACKGROUND

• 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.

  PMID: 9822003 BACKGROUND

Study Officials

• Jasmin YM Tong, FHKCA, FHKAM, FRCPC

  Hong Kong Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmin YM Tong, FHKCA, FHKAM, FRCPC (Anes)

CONTACT

+852 35133760; tym651@ha.org.hk

Vivian Yuen, FHKCA, FHKAM

CONTACT

+852 35133752; yuenmyv@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 26, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)