NCT07201350

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	distraciton technices	UTETC is a distraction method used during ECG procedures.

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-07-31
• Completion: 2022-11-01
• First posted: 2025-10-01
• Last updated: 2025-10-01

Locations

1 site across 1 country: Turkey (Türkiye)