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NCT Number: NCT07761637

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

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.

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Key information

Conditions

Pediatric Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

    Time frame: 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 $ms^2$

  2. Changes in Heart Rate Variability LF/HF Ratio

    Time frame: 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.

  3. Changes in Heart Rate Variability RMSSD

    Time frame: 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

  1. Pediatric Observational Anxiety Score (mYPAS-SF)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nai-Yun Chang, MD

CONTACT

[email protected]

+886-972-655-205

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Yunlin University of Science and Technology

Registry information

Official study title

Effectiveness of Non-Wearable Immersive Audiovisual Distraction in Alleviating Pediatric Anxiety in Emergency Department: A Stratified Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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