Pediatric AnxietyNCT07761637
Non-Wearable Audiovisual Distraction for Children's Medical Anxiety in the ED
A study testing Non-Wearable Audiovisual Distraction and Routine ED Care in people with Pediatric Anxiety, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pediatric Anxiety
- What is being tested?
- Non-Wearable Audiovisual Distraction and Routine ED Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin County, 640203
Nai-Yun Chang, MD, +886-972-655-205, gigi06060606@gmail.com
About this study
Official title: Effectiveness of Non-Wearable Immersive Audiovisual Distraction in Alleviating Pediatric Anxiety in Emergency Department: A Stratified Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Pediatric Anxiety
- Being tested
- Non-Wearable Audiovisual Distraction, Routine ED Care
- Keywords
- Audiovisual Distraction, Pediatric Emergency Medicine, Heart Rate Variability, Non-Wearable Technology, mYPAS-SF, Procedural Pain and Anxiety
- Medical subject headings
- Pain, Procedural, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Wearable Audiovisual DistractionBehavioural
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 CareOther
Standard pediatric emergency department care according to clinical guidelines without digital distraction devices.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Non-Wearable Audiovisual Distraction |
| Routine Care Group | Active comparator | Pediatric patients receive standard emergency department care without additional digital audiovisual distraction devices. Receives: Other: Routine ED Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 $ms^2$
Measured: 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.
Measured: 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).
Measured: 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)
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.
Measured: Assessed at baseline (pre-procedure) and immediately post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnxietyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned into two parallel groups: Non-Wearable Audiovisual Distraction Group or Routine Care Group.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Yunlin University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Nai-Yun Chang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761637
- Sponsor's protocol ID
- 202601226RINE
- Status last verified
- Jul 2026
- First submitted
- 2 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-Wearable Immersive Audiovisual Distraction in Alleviating Pediatric Anxiety in Emergency Department: A Stratified Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07761637
- Acronym / sponsor ID
- 202601226RINE
- Conditions
- Pediatric Anxiety
- Keywords
- Audiovisual Distraction, Pediatric Emergency Medicine, Heart Rate Variability, Non-Wearable Technology, mYPAS-SF, Procedural Pain and Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Yunlin University of Science and Technology
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned into two parallel groups: Non-Wearable Audiovisual Distraction Group or Routine Care Group.
| Arm | Type | Receives |
|---|---|---|
| Audiovisual Distraction Group | Experimental | Behavioral: Non-Wearable Audiovisual DistractionPediatric 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. |
| Routine Care Group | Active comparator | Other: Routine ED CarePediatric patients receive standard emergency department care without additional digital audiovisual distraction devices. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Wearable Audiovisual DistractionImplementation of a non-wearable mobile display system (LG StanbyME) providing gentle, low-stimulation audiovisual distraction and digital companionship to alleviate pediatric procedural anxiety. | Behavioural | Audiovisual Distraction Group |
| Routine ED CareStandard pediatric emergency department care according to clinical guidelines without digital distraction devices. | Other | Routine Care Group |
Primary outcome
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 $ms^2$
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.
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).
1 secondary outcome
Pediatric Observational Anxiety Score (mYPAS-SF)
Time frame: Assessed at baseline (pre-procedure) and immediately post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nai-Yun Chang, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Wearable Audiovisual Distraction and Routine ED Care in people with Pediatric Anxiety, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nai-Yun Chang, MD (+886-972-655-205, gigi06060606@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.