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Набор скоро начнётся NCT07736664

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

Без фазы С лечением Preoperative Anxiety Preoperative Fear Pediatric Surgery Day Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Operating Room Transport by Walking with Parent, Operating Room Transport by Stretcher, Operating Room Transport by Battery-Powered Ride-on Car.
Кому может быть актуально
Состояния в реестре: Preoperative Anxiety, Preoperative Fear, Pediatric Surgery, Day Surgery. Базовые параметры: 3 лет — 6 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура Operating Room Transport by Walking with Parent
    Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
  • Процедура Operating Room Transport by Stretcher
    Participants are transported to the operating room using a stretcher.
  • Процедура Operating Room Transport by Battery-Powered Ride-on Car
    Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.

Первичные конечные точки

  • Preoperative Anxiety Level [Срок оценки: Immediately before transfer to the operating room (preoperative period).]
Вторичные конечные точки (1)
  • Preoperative Fear Level [Срок оценки: Immediately before transfer to the operating room (preoperative period)]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07736664 · 30333

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗