Non-Wearable Audiovisual Distraction for Children's Medical Anxiety in the ED
Effectiveness of Non-Wearable Immersive Audiovisual Distraction in Alleviating Pediatric Anxiety in Emergency Department: A Stratified Randomized Controlled Trial
Pediatric emergency department (ED) visits often cause significant anxiety and stress for young patients due to unfamiliar environments and invasive medical procedures. Non-pharmacological interventions, such as distraction, are vital for reducing pediatric anxiety and improving procedural outcomes.
This study evaluates the effectiveness of a non-wearable, immersive audiovisual distraction system (LG StanbyME display) in alleviating pediatric anxiety during emergency department care, compared to standard care.
The main questions it aims to answer are:
Does non-wearable audiovisual distraction reduce anxiety levels in pediatric emergency patients compared to standard care?
Does the intervention improve physiological indicators of distress, such as Heart Rate Variability (HRV)?
Participants will:
Be randomly assigned to either the non-wearable audiovisual distraction group or the routine care group.
Undergo continuous physiological monitoring (HRV) and clinical anxiety assessment (mYPAS-SF) during their ED visit.
연구 개요
상세 설명
Pediatric anxiety in emergency settings can lead to uncooperative behavior, prolonged procedure times, and long-term medical fear. Traditional Virtual Reality (VR) headsets often face clinical limitations in pediatric EDs, such as user discomfort, sanitation challenges, and restricted head/eye movement.
To address these barriers, this stratified randomized controlled trial (RCT) introduces a non-wearable, highly mobile immersive display system (LG StanbyME) combined with interactive soothing content and digital companionship.
Pediatric patients aged 3 to 12 years presenting to the Emergency Department of National Taiwan University Hospital Yunlin Branch will be screened for eligibility. Eligible participants will be randomized into two arms:
Experimental Group: Receives non-wearable immersive audiovisual distraction via the mobile display during ED waiting and procedural periods.
Control Group: Receives standard pediatric ED care without digital distraction devices.
Primary outcomes include objective autonomic nervous system activity evaluated through continuous Heart Rate Variability (HRV) monitoring using a wearable ECG recorder (QOCA ecg103). Secondary outcomes include subjective pediatric anxiety scores assessed via the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF), parental anxiety, and staff satisfaction.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Nai-Yun Chang, MD
- 전화번호: +886-972-655-205
- 이메일: gigi06060606@gmail.com
연구 장소
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Yunlin County
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Douliu, Yunlin County, 대만, 640203
- National Taiwan University Hospital Yunlin Branch
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연락하다:
- Nai-Yun Chang, MD
- 전화번호: +886-972-655-205
- 이메일: gigi06060606@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Pediatric patients aged 6 to 12 years presenting to the Emergency Department.
- Requiring invasive medical procedures (e.g., blood sampling, intravenous line insertion, or laceration repair/suturing).
- Patient and legal guardian/parent willing and able to provide informed assent/consent and comply with study protocols.
Exclusion Criteria:
- Patients with severe developmental delay, cognitive impairment, or neurological disorders affecting communication or behavioral assessment.
- Patients with severe visual or hearing impairment that prevents interaction with the non-wearable display system.
- Hemodynamically unstable patients or those requiring immediate life-saving resuscitation.
- Patients with severe upper body or facial injuries that prevent the placement or operation of continuous ECG recorders.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Audiovisual Distraction Group
Pediatric patients receive non-wearable immersive audiovisual distraction via a mobile display (LG StanbyME presenting low-stimulation, guided soothing videos and simple interactive games) during emergency department procedures.
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Implementation of a non-wearable mobile display system (LG StanbyME) providing gentle, low-stimulation audiovisual distraction and digital companionship to alleviate pediatric procedural anxiety.
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활성 비교기: Routine Care Group
Pediatric patients receive standard emergency department care without additional digital audiovisual distraction devices.
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Standard pediatric emergency department care according to clinical guidelines without digital distraction devices.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Heart Rate Variability High-Frequency Power (HF-HRV)
기간: Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
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Continuous measurement of parasympathetic autonomic activity evaluated via HF power in normalized units (nu) or $ms^2$
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Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
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Changes in Heart Rate Variability LF/HF Ratio
기간: Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
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Autonomic nervous system balance assessed via the ratio of Low-Frequency to High-Frequency power.
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Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
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Changes in Heart Rate Variability RMSSD
기간: Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
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Short-term parasympathetic modulation evaluated via Root Mean Square of Successive Differences (RMSSD) in milliseconds (ms).
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Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pediatric Observational Anxiety Score (mYPAS-SF)
기간: Assessed at baseline (pre-procedure) and immediately post-procedure.
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Behavioral anxiety score assessed using the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF).
The tool evaluates 4 categories (activity, vocalization, emotional expressiveness, and state of arousal), yielding a total score ranging from 22.9 to 100, where higher scores indicate greater procedural anxiety.
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Assessed at baseline (pre-procedure) and immediately post-procedure.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nai-Yun Chang, MD, National Taiwan University Hospital
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
- 202601226RINE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
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