Non-Wearable Audiovisual Distraction for Children's Medical Anxiety in the ED

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.

• Non-Wearable Audiovisual Distraction (Behavioral): Implementation 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): Standard pediatric emergency department care according to clinical guidelines without digital distraction devices.

Primary outcomes

• Changes in Heart Rate Variability High-Frequency Power (HF-HRV) [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 [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 [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).

Secondary outcomes

• Pediatric Observational Anxiety Score (mYPAS-SF) [Assessed at baseline (pre-procedure) and immediately post-procedure.]: 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.

Sex: All, ages: 6 Years to 12 Years

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.

• Nai-Yun Chang, MD, Principal investigator, National Taiwan University Hospital