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临床试验/NCT07736664
NCT07736664尚未招募不适用

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

Ege University0 个研究点目标入组 66 人开始时间: 2026年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
主要终点
Preoperative Anxiety Level

研究概览

简要总结

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.

详细描述

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 (Investigator)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Routine Walking with Parent

Active Comparator

Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.

干预措施: Operating Room Transport by Walking with Parent (Procedure)

Stretcher Transport

Experimental

Participants are transported to the operating room using a stretcher.

干预措施: Operating Room Transport by Stretcher (Procedure)

Battery-Powered Ride-on Car Transport

Experimental

Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.

干预措施: Operating Room Transport by Battery-Powered Ride-on Car (Procedure)

结局指标

主要结局

Preoperative Anxiety Level

时间窗: 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.

次要结局

  • Preoperative Fear Level(Immediately before transfer to the operating room (preoperative period))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İlayda Tekelioğlu

Master's Student

Ege University

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