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临床试验/NCT07737041
NCT07737041已完成不适用

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

Merve Koyun1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Children's anxiety

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
7 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Children's anxiety

时间窗: 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.

次要结局

  • Children's Fear Scale (CFS)(5 minutes before echocardiography)

研究者

发起方
Merve Koyun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Merve Koyun

Lecturer Doctor

Ondokuz Mayıs University

研究点 (1)

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