- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
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
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
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
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Hong Kong, 중국
- Hong Kong Children's Hospital
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연락하다:
- Vivian Yuen, FHKCA, FHKAM
- 전화번호: +852 35133752
- 이메일: yuenmyv@ha.org.hk
-
연락하다:
- Jasmin YM Tong, FHKCA, FHKAM, FRCPC
- 전화번호: +852 35133760
- 이메일: tym651@ha.org.hk
-
수석 연구원:
- Jasmin YM Tong, FHKCA, FHKAM, FRCPC
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-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
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
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
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Interactive balloon game
Passive media
|
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다른: 6-8 years
older children
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Interactive balloon game
Passive media
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Physical restraint
기간: Perioperative/from anesthetic induction up to 15min
|
Yes or No
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Perioperative/from anesthetic induction up to 15min
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Degree of physical restraint
기간: 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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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.
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Perioperative/from anesthetic induction up to 15min
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Caregiver satisfaction and acceptability
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Jasmin YM Tong, FHKCA, FHKAM, FRCPC, Hong Kong Children's Hospital
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Breatheballoon
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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