NCT07356895

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

January 13, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2026

Expected
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2026

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 13, 2026

Last Update Submit

January 29, 2026

Conditions

Keywords

Autism Spectrum DisorderSocial StoriesPreoperative Anxiety

Outcome Measures

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).

    During anesthesia induction on the day of surgery.

Secondary Outcomes (3)

  • 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.

Study Arms (2)

Social Stories Group

ACTIVE COMPARATOR

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.

Behavioral: Social Stories Group

Routine Preoperative Preparation Group

ACTIVE COMPARATOR

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.

Behavioral: Routine Preoperative Preparation Group

Interventions

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.

Social Stories 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.

Routine Preoperative Preparation Group

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Elif Şule Özdemir Sezgi

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 21, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

August 3, 2026

Study Completion (Estimated)

August 20, 2026

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations