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Effects of Different Transport Methods on Preoperative Anxiety and Fear in Preschool Children

2026年8月10日 更新者:İlayda Tekelioğlu、Ege University
Preoperative anxiety and fear are common among preschool children undergoing surgery and may negatively affect perioperative cooperation and postoperative recovery. This study aims to evaluate the effects of three different operating room transport methods (walking with a parent, stretcher transport, and battery-powered ride-on car transport) on preoperative anxiety and fear levels in preschool children undergoing day surgery. The findings are expected to contribute to the development of child-friendly, non-pharmacological interventions to improve the perioperative experience of children.

研究概览

详细说明

Preoperative anxiety is frequently observed in preschool children undergoing surgical procedures. The unfamiliar hospital environment, separation from parents, and fear of anesthesia and surgery may increase children's anxiety and fear before surgery. Elevated preoperative anxiety has been associated with poor cooperation during anesthesia induction, increased postoperative pain, maladaptive behavioral changes, and delayed recovery.

Several non-pharmacological interventions have been developed to reduce children's anxiety before surgery. Among these, distraction techniques and child-friendly environmental modifications have shown promising results. Transporting children to the operating room using battery-powered ride-on cars has recently emerged as an innovative distraction strategy that may transform the transport process into a playful experience.

This controlled study aims to compare three different operating room transport methods in preschool children undergoing elective day surgery: routine transport by walking with a parent, transport by stretcher, and transport using a battery-powered ride-on car. Preoperative anxiety and fear will be assessed using validated pediatric assessment tools before surgery. The study findings may provide evidence for the effectiveness of child-friendly transport methods in reducing preoperative anxiety and fear and support the implementation of non-pharmacological interventions in pediatric surgical care.

研究类型

介入性

注册 (估计的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Children aged 3-6 years (36-72 months)
  • Scheduled to undergo elective surgery in the Department of Pediatric Surgery
  • Able to communicate appropriately for their age
  • Have sufficient cognitive development to respond to the study assessment scales
  • Child and parent/legal guardian are able to speak and understand Turkish
  • Written informed consent obtained from the child's legal guardian (and child assent obtained when appropriate)

Exclusion Criteria:

  • Presence of visual, hearing, or communication impairments that could interfere with study participation
  • Receipt of premedication requiring sedation due to an emergency condition
  • Presence of severe pain that could affect anxiety assessment before surgery
  • Inability to safely use the battery-powered ride-on car because of physical or mobility limitations before surgery
  • Withdrawal of consent by the child's legal guardian or the child's unwillingness to continue participation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Routine Walking with Parent
Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
实验性的:Stretcher Transport
Participants are transported to the operating room using a stretcher.
Participants are transported to the operating room using a stretcher.
实验性的:Battery-Powered Ride-on Car Transport
Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.
Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Preoperative Anxiety Level
大体时间:Immediately before transfer to the operating room (preoperative period).
Preoperative anxiety levels will be assessed using the Children's Anxiety Scale-State (CAS-S), a visual thermometer-like scale with scores ranging from 0 to 10. Higher scores indicate higher levels of state anxiety. Scores will be compared among preschool children transported to the operating room by walking with a parent, stretcher, or battery-powered ride-on car.
Immediately before transfer to the operating room (preoperative period).

次要结果测量

结果测量
措施说明
大体时间
Preoperative Fear Level
大体时间:Immediately before transfer to the operating room (preoperative period)
Preoperative fear levels will be assessed using the Children's Fear Scale (CFS), which consists of five facial expressions and is scored from 0 to 4. A score of 0 indicates no fear, while a score of 4 indicates severe fear. Higher scores indicate higher levels of fear. Scores will be compared among preschool children transported to the operating room by walking with a parent, stretcher, or battery-powered ride-on car.
Immediately before transfer to the operating room (preoperative period)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Nurdan Akçay Didişen, PhD、Ege university

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月31日

初级完成 (估计的)

2027年7月31日

研究完成 (估计的)

2027年7月31日

研究注册日期

首次提交

2026年7月26日

首先提交符合 QC 标准的

2026年7月26日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年8月10日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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