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Active Engagement Game Versus Passive Media During Pediatric Inhalational Induction

2026年8月26日 更新者: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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

128

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Jasmin YM Tong, FHKCA, FHKAM, FRCPC (Anes)
  • 電話番号:+852 35133760
  • メール:tym651@ha.org.hk

研究連絡先のバックアップ

  • 名前:Vivian Yuen, FHKCA, FHKAM
  • 電話番号:+852 35133752
  • メール:yuenmyv@ha.org.hk

研究場所

      • Hong Kong、中国
        • Hong Kong Children's Hospital
        • コンタクト:
          • Vivian Yuen, FHKCA, FHKAM
          • 電話番号:+852 35133752
          • メール:yuenmyv@ha.org.hk
        • コンタクト:
          • Jasmin YM Tong, FHKCA, FHKAM, FRCPC
          • 電話番号:+852 35133760
          • メール:tym651@ha.org.hk
        • 主任研究者:
          • Jasmin YM Tong, FHKCA, FHKAM, FRCPC

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
他の:3-5 years
patients of 3-5 years
Interactive balloon game
Passive media
他の:6-8 years
older children
Interactive balloon game
Passive media

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Physical restraint
時間枠:Perioperative/from anesthetic induction up to 15min
Yes or No
Perioperative/from anesthetic induction up to 15min
Degree of physical restraint
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Induction compliance
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Jasmin YM Tong, FHKCA, FHKAM, FRCPC、Hong Kong Children's Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2026年12月31日

研究の完了 (推定)

2027年2月28日

試験登録日

最初に提出

2026年8月18日

QC基準を満たした最初の提出物

2026年8月21日

最初の投稿 (実際)

2026年8月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月31日

QC基準を満たした最後の更新が送信されました

2026年8月26日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Breatheballoon

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いいえ

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