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

NCT ID: NCT07201350

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-11-01

Brief Summary

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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

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Conditions

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Anxiety Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

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

Study Groups

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Intervention

Group Type EXPERIMENTAL

distraciton technices

Intervention Type OTHER

UTETC is a distraction method used during ECG procedures.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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distraciton technices

UTETC is a distraction method used during ECG procedures.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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AYLİN ARIKAN

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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UTETC

Identifier Type: -

Identifier Source: org_study_id

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