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

Not Applicable

Completed

• Conditions: Anxiety; Fear

• Registration Number: NCT07201350
• Lead Sponsor: Ankara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-11-01
• Study First Submitted: 2024-01-06
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fear	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	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.

Trial Locations

Locations (1)

r Sami Ulus Maternity and Children's Health and Diseases Training and Research Hospital; Ankara, Turkey (Türkiye)