Animation-Based Video and Brochure-Based Education (NCT07737041) | Clinical Trial Compass
CompletedNot Applicable
Animation-Based Video and Brochure-Based Education
Turkey (Türkiye)75 participantsStarted 2024-03-15
Plain-language 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.
Who can participate
Age range
7 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.