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

NCT07761637 | Not Yet Recruiting

• 1 other identifier: 202601226RINE
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Anxiety

Keywords

Audiovisual Distraction; Pediatric Emergency Medicine; Heart Rate Variability; Non-Wearable Technology; mYPAS-SF; Procedural Pain and Anxiety

Outcome Measures

Primary Outcomes (3)

• 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 $ms\^2$

  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.

  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).

  Continuously measured from baseline (wait time, T0) through procedural period (T1/T2) up to 30 minutes post-procedure (recovery period, T3).

Secondary Outcomes (1)

• Pediatric Observational Anxiety Score (mYPAS-SF)

  Assessed at baseline (pre-procedure) and immediately post-procedure.

Study Arms (2)

Audiovisual Distraction Group

EXPERIMENTAL

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

Routine Care Group

ACTIVE COMPARATOR

Pediatric patients receive standard emergency department care without additional digital audiovisual distraction devices.

Other: Routine ED Care

Interventions

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.

Audiovisual Distraction Group

Routine ED Care OTHER

Standard pediatric emergency department care according to clinical guidelines without digital distraction devices.

Routine Care Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Yunlin University of Science and Technology: collaborator

Study Sites (1)

National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin County, 640203, Taiwan

Location

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Nai-Yun Chang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nai-Yun Chang, MD

CONTACT

+886-972-655-205; gigi06060606@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned into two parallel groups: Non-Wearable Audiovisual Distraction Group or Routine Care Group.

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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)

Locations

TW (1)