Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT07201350
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2024-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of an Undersea-Themed ECG Cover on Fear and Anxiety Levels in Children
Sponsor:
Ankara University
Organization:
Study Overview
Official Title:
The Impact on Fear and Anxiety Levels of Children of an Undersea-Themed Cover Designed for Electrocardiography Applications: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UTETC
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: