An interventional study of Non-Wearable Audiovisual Distraction and Routine ED Care in Pediatric Anxiety, sponsored by National Taiwan University Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care
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 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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 90 is close to the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Non-Wearable Audiovisual Distraction
Pediatric patients receive standard emergency department care without additional digital audiovisual distraction devices.
Other: Routine ED Care
Implementation of a non-wearable mobile display system (LG StanbyME) providing gentle, low-stimulation audiovisual distraction and digital companionship to alleviate pediatric procedural anxiety.
Standard 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 $ms\^2$
Time frame: Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
Changes in Heart Rate Variability LF/HF Ratio
Autonomic nervous system balance assessed via the ratio of Low-Frequency to High-Frequency power.
Time frame: Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
Changes in Heart Rate Variability RMSSD
Short-term parasympathetic modulation evaluated via Root Mean Square of Successive Differences (RMSSD) in milliseconds (ms).
Time frame: Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).
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.
Time frame: Assessed at baseline (pre-procedure) and immediately post-procedure.
Plan to share: Yes — De-identified individual participant data, including demographic characteristics (age, sex), baseline and post-procedural mYPAS-SF scores, and time-domain/frequency-domain Heart Rate Variability (HRV) parameters (HF, LF/HF ratio, RMSSD), will be shared with qualified researchers upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data will become available starting 6 months after publication of the primary manuscript and will remain available for up to 3 years
Access criteria: Data will be made available to qualified academic researchers for non-commercial scientific research. Requesters must submit a formal research proposal, sign a Data Use Agreement (DUA) to ensure participant confidentiality, and obtain approval from the Principal Investigator (Dr. Nai-Yun Chang)
Data sharing details ↗ · www.ylh.ntuh.gov.tw
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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