Effectiveness of Non-Wearable Immersive Audiovisual Distraction in Alleviating Pediatric Anxiety in Emergency Department: A Stratified Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in Heart Rate Variability High-Frequency Power (HF-HRV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Non-Wearable Audiovisual Distraction (Behavioral)
Routine Care Group
Pediatric patients receive standard emergency department care without additional digital audiovisual distraction devices.
干预措施: Routine ED Care (Other)
结局指标
主要结局
Changes in Heart Rate Variability High-Frequency Power (HF-HRV)
时间窗: Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
Continuous measurement of parasympathetic autonomic activity evaluated via HF power in normalized units (nu) or $ms\^2$
Changes in Heart Rate Variability LF/HF Ratio
时间窗: Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
Autonomic nervous system balance assessed via the ratio of Low-Frequency to High-Frequency power.
Changes in Heart Rate Variability RMSSD
时间窗: Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
Short-term parasympathetic modulation evaluated via Root Mean Square of Successive Differences (RMSSD) in milliseconds (ms).
次要结局
- Pediatric Observational Anxiety Score (mYPAS-SF)(Assessed at baseline (pre-procedure) and immediately post-procedure.)