Effect of Social Stories on Anesthesia Compliance in Children With Autism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorDiskapi Yildirim Beyazit Education and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Social Stories Group
BehavioralThe 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 evaluated.
Routine Preoperative Preparation Group
BehavioralRoutine 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Social Stories GroupActive comparator 1 intervention
Group B: Routine Preoperative Preparation GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anesthesia Induction Compliance
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).
Time frame
During anesthesia induction on the day of surgery.Secondary outcomes
1
Preoperative Anxiety Level
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS). The mYPAS is a validated observational scale evaluating preoperative anxiety across five behavioral domains (activity, vocalization, emotional expressivity, interaction with parents, and movement). Total scores range from 0 to 100, with higher scores indicating greater levels of preoperative anxiety. Clinically significant anxiety is generally considered at mYPAS scores ≥30-40.
Time frame
Preoperative period on the day of surgery.2
Postoperative Agitation / Emergence Delirium
Postoperative agitation and emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) Scale. The PAED scale consists of five items scored from 0 to 4, yielding a total score ranging from 0 to 20. Higher PAED scores indicate more severe emergence delirium, and a total score of ≥10 is generally accepted as clinically significant emergence delirium.
Time frame
Immediate postoperative period in the post-anesthesia care unit.3
Parental Satisfaction
Parental satisfaction with the perioperative process will be assessed using a 5-point Likert-type satisfaction scale, ranging from 1 (not satisfied at all) to 5 (very satisfied). Higher scores indicate greater parental satisfaction.
Time frame
On the day of surgery.Sponsors and contacts
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Diskapi Yildirim Beyazit Education and Research Hospital
Lead sponsor
Ankara Etlik City Hospital
Sponsor institution
Source ClinicalTrials.gov