NCT07737041

Brief Summary

This study was designed as a three-arm, parallel-group, randomized controlled trial to evaluate the effects of animation-based training versus brochure-based training before echocardiography on children's anxiety, fear, and physiological parameters. Research Hypotheses H1: Children aged 7-10 who receive animation-based educational videos prior to the echocardiography (ECHO) procedure will have lower levels of anxiety and fear compared to children receiving routine care. H2: Children aged 7-10 who receive brochure-based education before the ECHO procedure will have lower levels of anxiety and fear compared to children receiving routine care. H3: The effects of animation-based education and brochure-based education on children's anxiety and fear levels before the ECHO procedure differ. H4: In groups that received cartoon/video-based education and brochure-based education before the ECHO procedure, parents' satisfaction with nursing care is higher than in the routine care group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

July 26, 2026

Last Update Submit

July 26, 2026

Conditions

Keywords

Echocardiography, children, fear, anxiety, procedural education

Outcome Measures

Primary Outcomes (1)

  • Children's anxiety

    The CAS-D, on the other hand, is a visual analog scale developed by Ersig et al. that assesses state anxiety in children aged 4-10; it resembles a thermometer with a bulb and horizontal lines spaced in ascending intervals. The scale is scored on a 0-10 scale, with higher scores indicating higher levels of anxiety.

    5 minutes before echocardiography

Secondary Outcomes (1)

  • Children's Fear Scale (CFS)

    5 minutes before echocardiography

Study Arms (3)

Animation-Based Video Education

EXPERIMENTAL

In the animated based video group, in addition to the routine procedure, animated videos titled "Ipek's Echocardiography Adventure" (a character suitable for the 7-year-old age group) and "Can's Echocardiography Adventure" (a character suitable for the older age group)-each approximately four minutes long-were shown to the children via computer. A parent and a researcher were present with the child during the video viewing. The researcher answered any questions the children asked.

Other: Animated based video education

Brochure Based Education

ACTIVE COMPARATOR

In the brochure group, in addition to the routine procedure, children received standardized education about the echocardiography procedure using age-appropriate brochures prepared by the researchers. During the education session, the researcher answered the children's questions.

Other: Brochure based education

Control Group

NO INTERVENTION

In the control group, however, no educational or preparatory interventions were administered to the children beyond the routine care provided at the echocardiography clinic. As part of the routine procedure, the children were taken to a room located directly across from the outpatient clinic room where the echocardiogram would be performed. The room contained a computer, three chairs, a stretcher, and an echocardiography machine. The children were given an explanation such as, "Now, the doctor is going to perform an echocardiogram on you; you'll lie down on this stretcher and open your shirt. This is our machine…" while the echocardiography machine was shown to them.

Interventions

In the animated based video educaton group, in addition to the routine procedure, animated videos titled "Ipek's Echocardiography Adventure" (a character suitable for the 7-year-old age group) and "Can's Echocardiography Adventure" (a character suitable for the older age group)-each approximately four minutes long-were shown to the children via computer. A parent and a researcher were present with the child during the video viewing. The researcher answered any questions the children asked.

Animation-Based Video Education

In the brochure group, in addition to the routine procedure, children received standardized education about the echocardiography procedure using age-appropriate brochures prepared by the researchers. During the education session, the researcher answered the children's questions.

Brochure Based Education

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Be between the ages of 7 and 10
  • Be under follow-up at a pediatric cardiology outpatient clinic with a diagnosis of congenital heart disease, such as ASD, VSD, or PDA
  • Be scheduled to undergo a transthoracic echocardiogram for follow-up
  • Be able to speak Turkish
  • The child and parent must have the cognitive ability to communicate
  • Not having previously received the educational materials used in the study, even if the child has had an echocardiogram before
  • Obtaining written informed consent from the parent and voluntary consent from the child

You may not qualify if:

  • Situations requiring emergency ECHO Need for sedation
  • Inability to watch the video due to a hearing or visual impairment
  • Inability to respond to the scales due to a developmental or neurological disorder
  • Hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

July 26, 2026

First Posted

July 30, 2026

Study Start

March 15, 2024

Primary Completion

June 22, 2025

Study Completion

May 6, 2026

Last Updated

July 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations