Ride-on toy car transfer for preschool boys going to the operating room
Evaluation of the Effects of Ride-On Toy Car Use During Operating Room Transfer on Preoperative Anxiety and Postoperative Delirium in Preschool Children
This trial will see if moving boys aged 3–7 to the operating room in a ride-on toy car reduces preoperative anxiety and emergence delirium compared with a standard stretcher.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 96 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | Male |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07403747 on ClinicalTrials.gov |
What this trial studies
Male children aged 3–7 scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia are allocated to either transfer by a ride-on toy car or by a standard hospital stretcher, with other perioperative anesthesia care standardized between groups. Preoperative anxiety is measured at four predefined time points (waiting area, before transfer, in the OR corridor, and immediately before induction) using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and a Visual Analog Scale for Anxiety (VAS-A). Postoperative emergence delirium is evaluated with the Pediatric Anesthesia Emergence Delirium (PAED) scale in early recovery (immediately after extubation, on PACU admission, and during early PACU stay). The study compares the two transfer methods to see if toy-car transfer is associated with lower anxiety scores and reduced incidence or severity of emergence delirium.
Who should consider this trial
Good fit: Male children aged 3–7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia with ASA physical status I–II who can communicate verbally and whose parent or guardian provides consent.
Not a fit: Children outside the 3–7 age range, females (not enrolled), or those with psychiatric, neurological, developmental disorders, chronic pain, prior surgery, or who receive additional anxiolytic interventions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce children’s anxiety before anesthesia and lower the frequency or severity of emergence delirium, improving the perioperative experience for young patients.
How similar studies have performed: Small pediatric trials and play-based transport interventions have shown promising reductions in preoperative anxiety, but evidence specifically linking toy-car transfer to reduced emergence delirium is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male children aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia * Ability to communicate verbally * American Society of Anesthesiologists (ASA) physical status I or II * Written informed consent obtained from a parent or legal guardian Exclusion Criteria: * Presence of psychiatric disorders, genetic diseases, neurological or developmental disorders * Chronic pain conditions or ongoing medical treatments that may affect anxiety levels * Refusal to participate despite repeated encouragement by the investigators * Use of additional anxiolytic interventions or medications prior to the intervention outside the study protocol * Previous history of surgical procedures
Where this trial is running
Ankara
- Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Filiz Kaya, M.D
- Email: filiz.kaya17@saglik.gov.tr
- Phone: +90312552 60 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.