The Impact on Fear and Anxiety Levels of Children of an Undersea-Themed Cover Designed for Electrocardiography Applications: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- fear
研究概览
简要总结
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.
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
- Single (Outcomes Assessor)
盲法说明
The outcomes were assessed by two independent nurses who were blinded to group assignments.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to 12 years
- •Presented to the hospital with chest pain
- •No previous history of heart disease
- •Chest pain with a non-cardiac etiology (e.g., gastrointestinal disorders)
- •Undergoing their first ECG
排除标准
- •Reported fear of water, being underwater, or swimming
研究组 & 干预措施
Intervention
干预措施: distraciton technices (Other)
Control
结局指标
主要结局
fear
时间窗: 2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedure
Children's fear levels will be assessed using the Children's Fear Scale (CFS), which consists of five faces ranging from 0 (no fear) to 4 (extreme fear). Higher scores indicate higher levels of perceived fear.
anxiety
时间窗: 2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedure
Anxiety will be assessed using the Children's Emotional Manifestation Scale (CEMS), which evaluates five categories of observable emotional behavior. Each item is scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate higher levels of observed anxiety.
次要结局
未报告次要终点