ClinicalTrials.gg
CompletedNCT07356895Updated Oct 29, 2026

Effect of Social Stories on Anesthesia Compliance in Children With Autism

An interventional study of Social Stories Group and Routine Preoperative Preparation Group in Autism Spectrum Disorder and Social Stories, sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Diskapi Yildirim Beyazit Education and Research Hospital · Not applicable, Interventional, and Supportive care

Updated Oct 29, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Autism Spectrum Disorder with a site in Turkey — 11 open to participants now, 12 under way, none of them phase 3. Autism Spectrum Disorder · Turkey.

Enrollment
15th of 46
44 · median 35
Started
2026
with 6 others
No phase
46 of 56
8 open now
Registered
40th of 56
by date

Among the 56 studies in Autism Spectrum Disorder with a site in Turkey, this one is the 15th largest by enrollment of the 46 interventional ones, is one of 7 that started in 2026, is one of 46 with no phase, and was the 40th registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

No phasethis study46 · 8 open
Observational10 · 3 open

By the year they started

First in 2017; this study’s year is marked. 7 started in 2026.

Size and results

Median enrollment 35 across the 46 interventional studies, 74 across the 10 observational. Of the 44 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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.

03

Conditions studied

  • Autism Spectrum Disorder
  • Social Stories

Keywords

  • Autism Spectrum Disorder
  • Social Stories
  • Preoperative Anxiety
04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children diagnosed with Autism Spectrum Disorder
  • Patients scheduled for elective surgical procedures
  • Children aged 3 to 18 years
  • (ASA) physical status class I-II
  • Written 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

Exclusion criteria

Exclusion Criteria:

  • Children with 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 from a parent or legal guardian
  • Children receiving pharmacological treatment for a comorbid psychiatric disorder
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    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.

    Behavioral: Social Stories Group

  • Active comparator
    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.

    Behavioral: Routine Preoperative Preparation Group

Interventions

  • BehavioralSocial 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 evaluated.

  • BehavioralRoutine 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.

06

What researchers measure

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.

07

Study locations

1 site
  • Ankara Etlik City Hospital
    Ankara, 06000, Turkey (Türkiye)
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Oct 2026, 8 months.

Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 8 months is below that.

Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: primary completion Aug 2026 → Oct 2026 and completion Aug 2026 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2026
First posted
Jan 21, 2026
StartActual
Jan 30, 2026
Primary completionActual
Oct 14, 2026was Aug 2026
CompletionActual
Oct 27, 2026was Aug 2026
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 29, 2026
Primary completion
Aug 3, 2026→Oct 14, 2026 (actual)
Oct 29, 2026
Study completion
Aug 20, 2026→Oct 27, 2026 (actual)
Oct 29, 2026
Enrollment
40 (estimated)→44 (actual)
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Recruiting→Completed
    Primary completion Aug 3, 2026→Oct 14, 2026 (now actual)
    Study completion Aug 20, 2026→Oct 27, 2026 (now actual)
    Enrollment 40 (estimated)→44 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07356895
Lead sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Responsible party
Elif Sule Ozdemir (Principal Investigator, Ankara Etlik City Hospital) — Principal investigator
First posted
Jan 21, 2026
Start date
Jan 30, 2026
Primary completion
Oct 14, 2026
Completion
Oct 27, 2026
Last update
Oct 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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