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Completed

NCT Number: NCT07201350

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Fear Mental Disorders

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

r Sami Ulus Maternity and Children's Health and Diseases Training and Research Hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

distraciton technices

Other

UTETC is a distraction method used during ECG procedures.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Acronym: UTETC

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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