Pediatric Anxiety
Conditions
Keywords
Audiovisual Distraction, Pediatric Emergency Medicine, Heart Rate Variability, Non-Wearable Technology, mYPAS-SF, Procedural Pain and Anxiety
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALNon-Wearable Audiovisual Distraction
Implementation of a non-wearable mobile display system (LG StanbyME) providing gentle, low-stimulation audiovisual distraction and digital companionship to alleviate pediatric procedural anxiety.
OTHERRoutine ED Care
Standard pediatric emergency department care according to clinical guidelines without digital distraction devices.
Sponsors
National Taiwan University Hospital
National Yunlin University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants are randomly assigned into two parallel groups: Non-Wearable Audiovisual Distraction Group or Routine Care Group.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
CONTACTNai-Yun Chang, MD
PRINCIPAL_INVESTIGATORNai-Yun Chang, MD
National Taiwan University Hospital
Outcome results
None listed