Skip to main content
OpenTrials
Completed

NCT Number: NCT07737041

Animation-Based Video and Brochure-Based Education

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University

Samsun, Atakum, 55139, Turkey (Türkiye)

About this study

Echocardiography (ECHO) is a non-invasive and reliable imaging method widely used in the diagnosis, treatment planning, and long-term follow-up of congenital and acquired heart diseases in children. In pediatric cardiology, it is considered a preferred imaging method in clinical practice due to its high diagnostic accuracy, ease of use, and reproducibility (Ahmed et al., 2024; Lopez et al., 2010). Although it is a painless and non-invasive procedure, echocardiography can be a significant source of fear, stress, and anxiety for children and their families due to the unfamiliar hospital environment, encountering an unknown procedure, and the need to remain still during the procedure (Ahmed et al., 2024; Behera et al., 2025; Erel et al., 2025; Le May et al., 2022; Maharini et al., 2023; Yantie et al., 2023). Children, particularly those in the preschool years, may perceive medical procedures as threatening due to their cognitive and emotional developmental characteristics, and the sense of uncertainty they experience during the procedure can set the stage for the emergence of fear and anxiety (Chrisler et al., 2021; Romito et al., 2021). Pre-procedural anxiety in children can negatively affect not only their psychological well-being but also their cooperation, image quality, and the duration of the procedure (Bearden et al., 2012). Pre-procedural anxiety can cause physiological changes such as tachycardia, hypertension, and an increase in myocardial oxygen consumption. It can also lead to crying, agitation, restlessness, and a lack of cooperation. This situation not only causes the child to have a negative healthcare experience but also increases the workload of healthcare professionals, negatively impacts clinical workflow, and may contribute to higher healthcare costs (Behera et al., 2025; Ozdemir & Kuzlu Ayyıldız, 2024). These effects are particularly pronounced in preschool-aged children, highlighting the importance of preparing children in a manner appropriate to their developmental level prior to the intervention (Ahmed et al., 2024; Arikan & Esenay, 2025; Ayasrah & Ahmad, 2016; Le May et al., 2022).

Age-appropriate information for children should be tailored to their cognitive and emotional developmental levels (Bearden et al., 2012). Research in the field of developmental pediatrics shows that children's ways of perceiving and interpreting medical events differ depending on their age; therefore, educational approaches appropriate to their developmental level should be preferred over standard information provision (Ertem, 2008). Reducing uncertainty and supporting the child's sense of control over the task are considered to be among the key mechanisms for reducing pre-task anxiety (Chrisler et al., 2021). When pediatric nurses provide explanations in language that children can understand, describe the steps of a procedure, and answer children's questions, this helps foster a sense of trust. Preparing children in a manner appropriate to their developmental level and encouraging active family participation in the process are recommended as key components of child-friendly care (Romito et al., 2021). Therefore, preparing children using educational methods that are appropriate to their developmental level, easy to understand, and engaging is recognized as one of the fundamental approaches to reducing pre-procedure anxiety.

In recent years, the use of digital educational materials to prepare children for medical procedures has become increasingly widespread (Le May et al., 2022). Age-appropriate videos, animations, and visual educational materials help children understand abstract information more easily, reduce their perception of uncertainty, and alleviate pre-procedure anxiety (Erel et al., 2025; Srecharoen et al., 2025). This approach is also explained by Mayer's Cognitive Theory of Multimedia Learning. According to this theory, when information is presented simultaneously through visual and auditory channels, children find it easier to understand the information, their cognitive load decreases, and their level of learning increases (Mayer, 2020). Particularly among preschool and school-age children, the use of animations and videos to make abstract medical information more concrete can reduce preoperational children's sense of uncertainty and anxiety, thereby supporting their collaboration with healthcare professionals (Härter et al., 2021; Erel et al., 2025; Mayer & Fiorella, 2021; Monteiro Grilo et al., 2022).

Video-based instruction supports learning by capturing children's attention while presenting information in a more consistent manner than standard verbal explanations. Additionally, because children can see the task environment and the steps to be followed in advance while watching the videos, they are better prepared for the stimuli they will encounter during the task (Ahmed et al., 2024; Le May et al., 2022). Furthermore, video-based training is among the educational tools that support a family-centered care approach because it caters to children's different learning styles, can be rewatched, and allows parents to receive the same information simultaneously (Erel et al., 2025; Romito et al., 2021).

Brochures, on the other hand, are low-cost, easy-to-implement educational materials that allow parents to review the information before and after the procedure (Arikan & Esenay, 2025). Written materials, in particular, help parents access accurate information about the procedure and reinforce the verbal information provided by healthcare professionals. However, because they contain written information, it has been reported that their appeal and impact on learning may be limited, particularly among preschool-aged children (Monteiro Grilo et al., 2022; Ozdemir & Kuzlu Ayyildiz, 2024). Current evidence suggests that the use of developmentally appropriate, structured educational materials may be beneficial in preparing children for the procedure.

Evidence shows that structured preparation programs prior to pediatric diagnostic procedures reduce children's fear and anxiety, increase compliance with the procedure, and improve parental satisfaction. These preparation programs include verbal information, written materials, visual educational tools, psychosocial support, and child-friendly care practices (Ahmed et al., 2024; Ozdemir & Kuzlu Ayyildiz, 2024; Srecharoen et al., 2025; Yantie et al., 2023). In general, for managing fear and anxiety experienced by children during pediatric diagnostic procedures and echocardiography, patient preparation, psychosocial support, family education, and the creation of child-friendly care environments are recommended (Molu & Açıkgöz, 2022). McQuattie and colleagues demonstrate that structured educational programs administered prior to pediatric imaging procedures facilitate children's understanding of the procedure, reduce fear and anxiety, increase cooperation, and positively influence parental satisfaction (McQuattie & McQuattie, 2008).

Simply providing information may not be enough to reduce the anxiety children experience during medical procedures; parents also need to prepare for the process. It is well established that there is a strong correlation between children's anxiety levels and parental anxiety. For this reason, it is believed that family-centered educational approaches that target both the child and the parent can contribute to improving not only the child's experience but the entire care process. A family-centered care approach plays a significant role in reducing children's stress and anxiety by encouraging parents' active participation in the child's care process. When parents have accurate and sufficient information about the procedure, it helps reduce their own anxiety and positively impacts their children. Parents' active participation in preparing children for medical procedures is recognized as one of the key factors that increases children's cooperation and facilitates their compliance with the procedure (Erel et al., 2025). For this reason, it is believed that educational initiatives targeting both the child and the parent can improve not only the child's psychological adjustment but also the quality of care (Santapuram et al., 2021).

Although the effects of non-pharmacological distraction methods (TV, mobile devices, virtual reality) on anxiety and fear have been examined in light of advancing technologies in the field of pediatric cardiology, the vast majority of these studies have focused on distraction interventions (Behera et al., 2025). Studies directly comparing animation-based video education with brochure-based education in preparing children for an echocardiogram are quite limited. Furthermore, existing research falls short in jointly assessing children's levels of fear and anxiety and in examining parents' satisfaction with nursing care within the same study (Molu & Açıkgöz, 2022; Sajeev et al., 2021). This knowledge gap is significant for the development of evidence-based educational interventions that will improve children's echocardiography experience.

The aim of this study is to compare the effects of animation-based video education and brochure-based education, both administered prior to the echocardiography procedure, on children's fear and anxiety levels. A secondary objective of the study is to assess parents' satisfaction with nursing care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Animated based video education

Other

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.

Brochure based education

Other

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.

Primary outcomes

  1. Children's anxiety

    Time frame: 5 minutes before echocardiography

    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.

Secondary outcomes

  1. Children's Fear Scale (CFS)

    Time frame: 5 minutes before echocardiography

    CFS, is a self-report scale consisting of 500 items, developed by McMurtry et al. and validated for Turkish by Gerçeker et al. The scale is scored on a scale of 0-4, with higher scores indicating a higher level of fear.

Sponsors and collaborators

Lead sponsor

Merve Koyun

Other

Registry information

Official study title

Preparing Children for Echocardiography: Effects of Animation-Based Video and Brochure-Based Education on Anxiety and Fear

Acronym: PREP-ECHO

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.