Autism Spectrum DisorderNCT07356895
Effect of Social Stories on Anesthesia Compliance in Children With Autism
A study testing Social Stories Group and Routine Preoperative Preparation Group in people with Autism Spectrum Disorder and Social Stories, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Social Stories
- What is being tested?
- Social Stories Group and Routine Preoperative Preparation Group
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2026to 27 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Social Stories Technique on Anesthesia Compliance in Children With Autism Spectrum Disorder
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.
- Conditions
- Autism Spectrum Disorder, Social Stories
- Being tested
- Social Stories Group, Routine Preoperative Preparation Group
- Keywords
- Autism Spectrum Disorder, Social Stories, Preoperative Anxiety
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Stories GroupBehavioural
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 Preparation GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Routine Preoperative Preparation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During anesthesia induction on the day of surgery.
Secondary outcomes (3)
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.
Measured: Preoperative period on the day of surgery.
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.
Measured: Immediate postoperative period in the post-anesthesia care unit.
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.
Measured: On the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start30 Jan 2026
- Primary completion14 Oct 2026
- Study completion27 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Sule Ozdemir, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356895
- Sponsor's protocol ID
- AEŞH-EK-2025-311
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Social Stories Technique on Anesthesia Compliance in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07356895
- Acronym / sponsor ID
- AEŞH-EK-2025-311
- Conditions
- Autism Spectrum Disorder, Social Stories
- Keywords
- Autism Spectrum Disorder, Social Stories, Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 14 Oct 2026 (actual)
- Study completion
- 27 Oct 2026 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Stories Group | Active comparator | Behavioral: Social Stories GroupParticipants 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. |
| Routine Preoperative Preparation Group | Active comparator | Behavioral: Routine Preoperative Preparation GroupParticipants 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Stories GroupThe 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. | Behavioural | Social Stories Group |
| Routine Preoperative Preparation GroupRoutine 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. | Behavioural | Routine Preoperative Preparation Group |
Primary outcome
Anesthesia Induction Compliance
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).
3 secondary outcomes
Preoperative Anxiety Level
Time frame: Preoperative period on the day of surgery.
Postoperative Agitation / Emergence Delirium
Time frame: Immediate postoperative period in the post-anesthesia care unit.
Parental Satisfaction
Time frame: On the day of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Stories Group and Routine Preoperative Preparation Group in people with Autism Spectrum Disorder and Social Stories, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia Induction Compliance (time frame: During anesthesia induction on the day of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.