AnxietyUTETCNCT07201350
The Effect of an Undersea-Themed ECG Cover on Fear and Anxiety Levels in Children
A study testing distraciton technices in people with Anxiety and Fear, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Aims: To evaluate the impact of an undersea-themed examination table cover (UTETC) designed for electrocardiography (ECG) procedures on fear and anxiety levels in children. Background: Children may experience fear and anxiety not only during painful procedures but also during painless interventions such as ECG. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- What is being tested?
- distraciton technices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 12 years
- Presented to the hospital with chest pain
- No previous history of heart disease
- Chest pain with a non-cardiac etiology (e.g., gastrointestinal disorders)
- Undergoing their first ECG
Who cannot join
- -Reported fear of water, being underwater, or swimming
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
r Sami Ulus Maternity and Children's Health and Diseases Training and Research Hospital
Ankara
About this study
Official title: The Impact on Fear and Anxiety Levels of Children of an Undersea-Themed Cover Designed for Electrocardiography Applications: A Randomized Controlled Trial
Aims: To evaluate the impact of an undersea-themed examination table cover (UTETC) designed for electrocardiography (ECG) procedures on fear and anxiety levels in children.
Background: Children may experience fear and anxiety not only during painful procedures but also during painless interventions such as ECG. The unfamiliar environment, equipment, and separation from caregivers can contribute to emotional distress.
Read more
Design: This is a single-blind, randomized controlled trial.
Methods: The study was conducted with 80 children aged 3-12 years who underwent ECG procedures in a pediatric emergency department. Participants were randomly assigned to either the control group (n = 40) or the intervention group (n = 40) using block randomization. Data were collected using the Child Fear Scale and the Children's Emotional Manifestation Scale.
Relevance to Clinical Practice: The UTETC represents a potential non-pharmacological intervention aimed at improving the emotional comfort of children during ECG procedures.
- Being tested
- distraciton technices
- Keywords
- children, Pediatric ECG, Undersea-themed cover, Distraction technique, Pediatric emergency
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distraciton technicesOther
UTETC is a distraction method used during ECG procedures.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: distraciton technices |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
fear
Children's fear levels will be assessed using the Children's Fear Scale (CFS), which consists of five faces ranging from 0 (no fear) to 4 (extreme fear). Higher scores indicate higher levels of perceived fear.
Measured: 2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedure
anxiety
Anxiety will be assessed using the Children's Emotional Manifestation Scale (CEMS), which evaluates five categories of observable emotional behavior. Each item is scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate higher levels of observed anxiety.
Measured: 2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Apr 2022
- Primary completion31 Jul 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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 were stratified by age and gender, and then assigned to the intervention or control group using block randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYLİN ARIKAN, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201350
- Sponsor's protocol ID
- UTETC
- Acronym
- UTETC
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on Fear and Anxiety Levels of Children of an Undersea-Themed Cover Designed for Electrocardiography Applications: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07201350
- Acronym / sponsor ID
- UTETC / UTETC
- Keywords
- children, Pediatric ECG, Undersea-themed cover, Distraction technique, Pediatric emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 1 Oct 2025 (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.
Aims: To evaluate the impact of an undersea-themed examination table cover (UTETC) designed for electrocardiography (ECG) procedures on fear and anxiety levels in children.
Background: Children may experience fear and anxiety not only during painful procedures but also during painless interventions such as ECG. The unfamiliar environment, equipment, and separation from caregivers can contribute to emotional distress.
Design: This is a single-blind, randomized controlled trial.
Methods: The study was conducted with 80 children aged 3-12 years who underwent ECG procedures in a pediatric emergency department. Participants were randomly assigned to either the control group (n = 40) or the intervention group (n = 40) using block randomization. Data were collected using the Child Fear Scale and the Children's Emotional Manifestation Scale.
Relevance to Clinical Practice: The UTETC represents a potential non-pharmacological intervention aimed at improving the emotional comfort of children during ECG procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were stratified by age and gender, and then assigned to the intervention or control group using block randomization.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: distraciton technices |
| Control | No intervention | – |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 3 to 12 years
- Presented to the hospital with chest pain
- No previous history of heart disease
- Chest pain with a non-cardiac etiology (e.g., gastrointestinal disorders)
- Undergoing their first ECG
Key exclusion criteria (1 listed)
- -Reported fear of water, being underwater, or swimming
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 |
|---|---|---|
| distraciton technicesUTETC is a distraction method used during ECG procedures. | Other | Intervention |
Primary outcome
fear
Time frame: 2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedure
Children's fear levels will be assessed using the Children's Fear Scale (CFS), which consists of five faces ranging from 0 (no fear) to 4 (extreme fear). Higher scores indicate higher levels of perceived fear.
anxiety
Time frame: 2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedure
Anxiety will be assessed using the Children's Emotional Manifestation Scale (CEMS), which evaluates five categories of observable emotional behavior. Each item is scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate higher levels of observed anxiety.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distraciton technices in people with Anxiety and Fear, run by Ankara University at 1 site in Turkey (Türkiye).
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 1 Oct 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fear (time frame: 2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedure). The study lists 2 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 1 Oct 2025.