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

NCT07201350 | Completed

• 1 other identifier: UTETC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Fear

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedure

Study Arms (2)

Intervention

EXPERIMENTAL

Other: distraciton technices

Control

NO INTERVENTION

Interventions

distraciton technices OTHER

UTETC is a distraction method used during ECG procedures.

Intervention

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Reported fear of water, being underwater, or swimming

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes were assessed by two independent nurses who were blinded to group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

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

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: October 1, 2025
• Study Start: April 1, 2022
• Primary Completion: July 31, 2022
• Study Completion: November 1, 2022
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)