The Effect of the Social Stories Technique on Anesthesia Compliance in Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Anesthesia Induction Compliance
研究概览
简要总结
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.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Social Stories Group
Participants in this arm will receive the Social Stories Technique as a behavioral preoperative preparation intervention. Following informed consent, families will be provided with age- and developmentally appropriate Social Stories materials describing the anesthesia and surgical process using simple language and visual supports. Parents will be instructed to review the Social Stories with their child once daily.
干预措施: Social Stories Group (Behavioral)
Routine Preoperative Preparation Group
Participants in this arm will receive standard preoperative information as routinely provided in clinical practice. This includes verbal explanation of the anesthesia and surgical process given to the child's caregivers during the preoperative anesthesia consultation. No Social Stories materials or additional behavioral preparation tools will be provided.
干预措施: Routine Preoperative Preparation Group (Behavioral)
结局指标
主要结局
Anesthesia Induction Compliance
时间窗: During anesthesia induction on the day of surgery.
Behavioral cooperation during anesthesia induction in children with Autism Spectrum Disorder will be assessed by compliance with face mask application and/or intravenous cannulation using the Induction Compliance Checklist (ICC).
次要结局
- Preoperative Anxiety Level(Preoperative period on the day of surgery.)
- Postoperative Agitation / Emergence Delirium(Immediate postoperative period in the post-anesthesia care unit.)
- Parental Satisfaction(On the day of surgery.)
研究者
Elif Sule Ozdemir
Principal Investigator
Ankara Etlik City Hospital