Ankara Etlik City Hospital
Ankara, 06000, Turkey (Türkiye)
Location status: Recruiting
Location contact
Aslı Dönmez, Prof
CONTACT
Elif Şule Özdemir Sezgi, MD
CONTACT
NCT Number: NCT07356895
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.
Interested in participating?
Request Info3 year–18 year
All sexes
Interventional
Not applicable
Ankara, 06000, Turkey (Türkiye)
Location status: Recruiting
Aslı Dönmez, Prof
CONTACT
Elif Şule Özdemir Sezgi, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 evaluated.
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.
Time frame: 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).
Time frame: Preoperative period on the day of surgery.
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: Immediate postoperative period in the post-anesthesia care unit.
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: On the day of surgery.
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.
Contact information is provided by the study sponsor or research team.
Aslı Dönmez
CONTACT
Elif Şule Özdemir Sezgi
CONTACT
Diskapi Yildirim Beyazit Education and Research Hospital
Other Gov
The Effect of the Social Stories Technique on Anesthesia Compliance in Children With Autism Spectrum Disorder
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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