- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jasmin YM Tong, FHKCA, FHKAM, FRCPC (Anes)
- Número de teléfono: +852 35133760
- Correo electrónico: tym651@ha.org.hk
Copia de seguridad de contactos de estudio
- Nombre: Vivian Yuen, FHKCA, FHKAM
- Número de teléfono: +852 35133752
- Correo electrónico: yuenmyv@ha.org.hk
Ubicaciones de estudio
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Hong Kong, Porcelana
- Hong Kong Children's Hospital
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Contacto:
- Vivian Yuen, FHKCA, FHKAM
- Número de teléfono: +852 35133752
- Correo electrónico: yuenmyv@ha.org.hk
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Contacto:
- Jasmin YM Tong, FHKCA, FHKAM, FRCPC
- Número de teléfono: +852 35133760
- Correo electrónico: tym651@ha.org.hk
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Investigador principal:
- Jasmin YM Tong, FHKCA, FHKAM, FRCPC
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 3-5 years
patients of 3-5 years
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Interactive balloon game
Passive media
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Otro: 6-8 years
older children
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Interactive balloon game
Passive media
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical restraint
Periodo de tiempo: Perioperative/from anesthetic induction up to 15min
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Yes or No
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Perioperative/from anesthetic induction up to 15min
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Degree of physical restraint
Periodo de tiempo: Perioperative/from anesthetic induction up to 15min
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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
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Perioperative/from anesthetic induction up to 15min
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Induction compliance
Periodo de tiempo: Perioperative/from anesthetic induction up to 15min
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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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jasmin YM Tong, FHKCA, FHKAM, FRCPC, Hong Kong Children's Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Breatheballoon
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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