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Active Engagement Game Versus Passive Media During Pediatric Inhalational Induction

2026년 8월 26일 업데이트: Yick Man Jasmin Tong, Hong Kong Children's Hospital

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.

연구 개요

상태

아직 모집하지 않음

상세 설명

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.

연구 유형

중재적

등록 (추정된)

128

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Jasmin YM Tong, FHKCA, FHKAM, FRCPC (Anes)
  • 전화번호: +852 35133760
  • 이메일: tym651@ha.org.hk

연구 연락처 백업

  • 이름: Vivian Yuen, FHKCA, FHKAM
  • 전화번호: +852 35133752
  • 이메일: yuenmyv@ha.org.hk

연구 장소

      • Hong Kong, 중국
        • Hong Kong Children's Hospital
        • 연락하다:
        • 연락하다:
          • Jasmin YM Tong, FHKCA, FHKAM, FRCPC
          • 전화번호: +852 35133760
          • 이메일: tym651@ha.org.hk
        • 수석 연구원:
          • Jasmin YM Tong, FHKCA, FHKAM, FRCPC

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: 3-5 years
patients of 3-5 years
Interactive balloon game
Passive media
다른: 6-8 years
older children
Interactive balloon game
Passive media

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Physical restraint
기간: Perioperative/from anesthetic induction up to 15min
Yes or No
Perioperative/from anesthetic induction up to 15min
Degree of physical restraint
기간: 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.
Perioperative/from anesthetic induction up to 15min

2차 결과 측정

결과 측정
측정값 설명
기간
Induction compliance
기간: 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.
Perioperative/from anesthetic induction up to 15min
Caregiver satisfaction and acceptability
기간: Within 24hrs after anesthetic induction, during PACU stay
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
기간: Within 24 hours after anesthetic induction, during PACU stay or, if the child remains sleepy, on the ward
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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Jasmin YM Tong, FHKCA, FHKAM, FRCPC, Hong Kong Children's Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2027년 2월 28일

연구 등록 날짜

최초 제출

2026년 8월 18일

QC 기준을 충족하는 최초 제출

2026년 8월 21일

처음 게시됨 (실제)

2026년 8월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 26일

마지막으로 확인됨

2026년 8월 1일

추가 정보

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