Меню
Идёт набор NCT07356895

Effect of Social Stories on Anesthesia Compliance in Children With Autism

Без фазы С лечением Autism Spectrum Disorder Social Stories

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: Social Stories Group, Routine Preoperative Preparation Group.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder, Social Stories. Базовые параметры: 3 лет — 18 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of the Social Stories Technique on Anesthesia Compliance in Children With Autism Spectrum Disorder

Обзор

Children with Autism Spectrum Disorder (ASD) frequently experience heightened anxiety and reduced cooperation during the perioperative period, which can complicate anesthesia induction and negatively affect procedural safety and efficiency. Non-pharmacological behavioral preparation methods that enhance predictability and understanding of medical procedures may improve anesthesia-related cooperation in this vulnerable population. The Social Stories Technique is a structured, visual-based behavioral intervention designed to support children with ASD by explaining upcoming experiences in a clear and developmentally appropriate manner. This prospective controlled study aims to evaluate the effect of the Social Stories Technique on anesthesia compliance and preoperative anxiety in children with Autism Spectrum Disorder undergoing elective surgery. Children in the intervention group will receive Social Stories materials to be reviewed with their families prior to surgery, while the control group will receive standard preoperative information only. Primary and secondary outcomes will include anesthesia induction compliance, preoperative anxiety levels. The findings of this study are expected to contribute evidence regarding the effectiveness of a low-risk, non-pharmacological behavioral intervention to improve perioperative care in children with ASD.

Вмешательства

  • Поведенческое Social Stories Group
    The Social Stories Technique is a non-pharmacological behavioral intervention designed to prepare children with Autism Spectrum Disorder for anesthesia. Social Stories materials will be provided to families and will be read to the child by caregivers once daily for 7-14 days prior to surgery. The effect of the intervention on reducing preoperative anxiety and on cooperation during anesthesia induction-specifically compliance with intravenous cannulation and/or face mask application-will be evalu
  • Поведенческое Routine Preoperative Preparation Group
    Routine preoperative care consists of standard verbal information provided to caregivers regarding the anesthesia and surgical process during the preoperative anesthesia consultation. No Social Stories materials or additional behavioral preparation interventions will be used. Preoperative anxiety and cooperation during anesthesia induction, including compliance with intravenous cannulation and/or face mask application, will be evaluated.

Первичные конечные точки

  • Anesthesia Induction Compliance [Срок оценки: During anesthesia induction on the day of surgery.]
Вторичные конечные точки (3)
  • Preoperative Anxiety Level [Срок оценки: Preoperative period on the day of surgery.]
  • Postoperative Agitation / Emergence Delirium [Срок оценки: Immediate postoperative period in the post-anesthesia care unit.]
  • Parental Satisfaction [Срок оценки: On the day of surgery.]

Критерии участия

Критерии включения

  • Children diagnosed with Autism Spectrum Disorder
  • Patients scheduled for elective surgical procedures
  • Children aged 3 to 18 years
  • American Society of Anesthesiologists (ASA) physical status class I-II
  • Written informed consent obtained from a parent or legal guardian
  • Caregivers willing and able to read the Social Stories materials at home as instructed
  • Caregivers able to understand the Social Stories materials prepared in the Turkish language

Критерии исключения

  • Children with ASA physical status class III or higher systemic disease
  • Patients requiring emergency surgery
  • Children with severe intellectual disability or significant visual or hearing impairment
  • History of severe behavioral problems during previous general anesthesia
  • Families unable or unwilling to comply with the Social Stories intervention during the study period
  • Inability to obtain written informed consent from a parent or legal guardian
  • Children receiving pharmacological treatment for a comorbid psychiatric disorder

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
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ankara Etlik City Hospital — Ankara

Идентификаторы

NCT: NCT07356895 · AEŞH-EK-2025-311

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗