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.
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.
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.
Parallel
Non-Wearable Audiovisual Distraction
BehavioralImplementation of a non-wearable mobile display system (LG StanbyME) providing gentle, low-stimulation audiovisual distraction and digital companionship to alleviate pediatric procedural anxiety.
Routine ED Care
Other interventionStandard pediatric emergency department care according to clinical guidelines without digital distraction devices.
Changes in Heart Rate Variability High-Frequency Power (HF-HRV)
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
Autonomic nervous system balance assessed via the ratio of Low-Frequency to High-Frequency power.
Changes in Heart Rate Variability RMSSD
Short-term parasympathetic modulation evaluated via Root Mean Square of Successive Differences (RMSSD) in milliseconds (ms).
Pediatric Observational Anxiety Score (mYPAS-SF)
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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National Taiwan University Hospital
Lead sponsor
National Yunlin University of Science and Technology
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
