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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Nai-Yun Chang, MD
- 電話番号：+886-972-655-205
- メール：gigi06060606@gmail.com
研究場所
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Yunlin County
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Douliu、Yunlin County、台湾、640203
- National Taiwan University Hospital Yunlin Branch
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コンタクト：
- Nai-Yun Chang, MD
- 電話番号：+886-972-655-205
- メール：gigi06060606@gmail.com
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-
参加基準
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
説明
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.
研究計画
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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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 |
|---|---|---|
|
Changes in Heart Rate Variability High-Frequency Power (HF-HRV)
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pediatric Observational Anxiety Score (mYPAS-SF)
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Nai-Yun Chang, MD、National Taiwan University Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 202601226RINE
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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