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The Effect of an Undersea-Themed ECG Cover on Fear and Anxiety Levels in Children

The Impact on Fear and Anxiety Levels of Children of an Undersea-Themed Cover Designed for Electrocardiography Applications: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07201350
Acronym
UTETC
Enrollment
80
Registered
2025-10-01
Start date
2022-04-01
Completion date
2022-11-01
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Fear

Keywords

children, Pediatric ECG, Undersea-themed cover, Distraction technique, Pediatric emergency

Brief 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. 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.

Interventions

OTHERdistraciton technices

UTETC is a distraction method used during ECG procedures.

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcomes were assessed by two independent nurses who were blinded to group assignments.

Intervention model description

Participants were stratified by age and gender, and then assigned to the intervention or control group using block randomization.

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

-Reported fear of water, being underwater, or swimming

Design outcomes

Primary

MeasureTime frameDescription
fear2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedureChildren'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.
anxiety2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedureAnxiety 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026