- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07787351
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jasmin YM Tong, FHKCA, FHKAM, FRCPC (Anes)
- Numer telefonu: +852 35133760
- E-mail: tym651@ha.org.hk
Kopia zapasowa kontaktu do badania
- Nazwa: Vivian Yuen, FHKCA, FHKAM
- Numer telefonu: +852 35133752
- E-mail: yuenmyv@ha.org.hk
Lokalizacje studiów
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-
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Hong Kong, Chiny
- Hong Kong Children's Hospital
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Kontakt:
- Vivian Yuen, FHKCA, FHKAM
- Numer telefonu: +852 35133752
- E-mail: yuenmyv@ha.org.hk
-
Kontakt:
- Jasmin YM Tong, FHKCA, FHKAM, FRCPC
- Numer telefonu: +852 35133760
- E-mail: tym651@ha.org.hk
-
Główny śledczy:
- Jasmin YM Tong, FHKCA, FHKAM, FRCPC
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: 3-5 years
patients of 3-5 years
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Interactive balloon game
Passive media
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Inny: 6-8 years
older children
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Interactive balloon game
Passive media
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Physical restraint
Ramy czasowe: Perioperative/from anesthetic induction up to 15min
|
Yes or No
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Perioperative/from anesthetic induction up to 15min
|
|
Degree of physical restraint
Ramy czasowe: 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
|
Perioperative/from anesthetic induction up to 15min
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Induction compliance
Ramy czasowe: Perioperative/from anesthetic induction up to 15min
|
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.
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Perioperative/from anesthetic induction up to 15min
|
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Caregiver satisfaction and acceptability
Ramy czasowe: Within 24hrs after anesthetic induction, during PACU stay
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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).
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Within 24hrs after anesthetic induction, during PACU stay
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Child self-reported acceptability
Ramy czasowe: Within 24 hours after anesthetic induction, during PACU stay or, if the child remains sleepy, on the ward
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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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Within 24 hours after anesthetic induction, during PACU stay or, if the child remains sleepy, on the ward
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Jasmin YM Tong, FHKCA, FHKAM, FRCPC, Hong Kong Children's Hospital
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Breatheballoon
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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