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临床试验/NCT07056816
NCT07056816已完成不适用

Çocuk Acil Serviste Nebülize İnhalasyon Alan Çocuklarda İnteraktif Oyuncak ve Robot'un Anksiyete ve Korkuya Etkisi: Randomize Kontrollü Çalışma

Aylin Kurt1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Aylin Kurt
入组人数
72
试验地点
1
主要终点
The level of anxiety is evaluated using the Children Anxiety Meter-State

研究概览

简要总结

Pediatric emergency services are of critical importance for pediatric patients admitted due to sudden illnesses and traumas. However, these environments are serious sources of stress and anxiety for children due to reasons such as uncertainty, pain, and separation anxiety. The emergency service experience can have long-term effects on the child's psychological state and negatively affect the success of medical interventions. Therefore, the development and implementation of various methods to reduce children's anxiety has become a great necessity. In recent years, interactive toys and robotic systems have been increasingly used in medical settings to reduce children's anxiety. Such technological tools have been shown to provide emotional support to children, reduce stress levels by distracting them, and make medical procedures more tolerable. However, there is not enough evidence-based research on the effectiveness of interactive toys and robots, especially in emergency settings, during common but frightening procedures such as nebulized inhalation. This study aims to evaluate the effect of interactive toys and robots on anxiety and fear in children receiving nebulized inhalation treatment in pediatric emergency services. This study, which will be conducted using a randomized controlled design, will make a significant contribution to understanding and improving children's psychological responses to medical procedures. The study was planned as a randomized controlled trial. The population of this study will be conducted in the pediatric emergency department of Ankara Provincial Health Directorate Yıldırım Beyazıt University Yenimahalle Education and Research Hospital between 05.05.2025-05.05.2026. The sample of this study will consist of 72 children aged between 4-10 who agreed to participate in the study and met the inclusion criteria and who received nebulized inhalation treatment and met the inclusion criteria.

Hypotheses of the study:

H0 = Playing with interactive toys and interactive robots during nebulized inhalation treatment has no effect on anxiety and fear in children.

H1 = Playing with interactive toys and interactive robots during nebulized inhalation treatment is effective in reducing anxiety and fear in children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • •Being a child between the ages of 4-10,
  • •Receiving nebulized inhalation treatment in the pediatric emergency department,
  • •The parent agreeing to participate in the research,
  • •The child not having speech or vision impairments or any other disabilities that would hinder or prevent communication.

排除标准

  • •Children whose parents' permission cannot be obtained
  • •The child's speech and vision impairment, or any other disability that would make communication difficult or prevent it.

研究组 & 干预措施

Interactive Doll Group

Experimental

Interactive Doll: Their hearts beat and they say "hello" as soon as you put it on your finger because they know it's really yours! They also have a different personality and reactions when they open and close your finger. With sensors in their head, mouth and belly, Fingerlings respond to your touch and will respond to you. You can also shake them and turn them upside down for even more reactions because they love to monkey around. And their positive tail can hang down or flip up so they can sit on your table or shelf. Kids will play with the Interactive Doll during the inhalation treatment.

干预措施: Interactive Doll (Other)

Interactive Robot Group

Experimental

Interactive Robot: It has an interactive design that improves children's music listening and learning skills. It attracts children's attention with its vibrant colors and cute design, and teaches them while having fun. It has a voice imitation feature and a response feature that makes different sounds when its head is touched. Children will play with the Interactive Robot during inhalation treatment.

干预措施: Interactive Robot (Other)

Control Group

No Intervention

The standard information given to all children receiving nebulized inhalation treatment in the pediatric emergency department will be given to the children in the control group.

结局指标

主要结局

The level of anxiety is evaluated using the Children Anxiety Meter-State

时间窗: during the procedure

The Children's Anxiety Meter (CAM-S) assesses children's anxiety in clinical settings and is used prior to medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom and contains horizontal lines at intervals going upwards. Scale scores range from 0 to 10, where higher values represent higher anxiety. Personal reports and records from children, their parents, the researcher, and the nurse, who are asked to mark the scale with a pen, are used to assess the anxiety levels of children

次要结局

  • The level of anxiety is evaluated using the Child Fear Scale(during the procedure)

研究者

发起方
Aylin Kurt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aylin Kurt

Assistant Professor

Bartın Unıversity

研究点 (1)

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