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Ride-On Toy Car Use During Operating Room Transfer in Preschool Children

Evaluation of the Effects of Ride-On Toy Car Use During Operating Room Transfer on Preoperative Anxiety and Postoperative Delirium in Preschool Children

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07403747
Enrollment
96
Registered
2026-02-11
Start date
2025-11-01
Completion date
2026-04-30
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium in Pediatric Anesthesia, Preoperative Anxiety

Keywords

Pediatric anesthesia, Preoperative anxiety, Toy car intervention, Emergence delirium

Brief summary

The goal of this clinical trial is to determine whether the method of transfer to the operating room can reduce preoperative anxiety and postoperative emergence delirium in male children aged 3 to 7 years undergoing elective adenoidectomy and/or tonsillectomy. The main questions it aims to answer are: * Does transfer using a ride-on toy car reduce preoperative anxiety compared with standard stretcher transfer? * Does this transfer method affect the incidence and severity of postoperative emergence delirium? Researchers will compare toy car transfer with standard hospital stretcher transfer to see if the toy car transfer is associated with lower anxiety levels and reduced emergence delirium. Participants will: * Transfer to the operating room either using a ride-on toy car or a standard hospital stretcher * Have preoperative anxiety assessed at predefined time points * Be evaluated for postoperative emergence delirium during recovery

Detailed description

This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. The study will include male children aged 3 to 7 years who are scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia. Participants will be allocated into two groups. In Group 1, children will be transferred from the waiting area to the operating room using a ride-on toy car. In Group 2, children will be transferred using a standard hospital stretcher according to routine clinical practice. All other perioperative anesthesia management protocols will be standardized between groups. Preoperative anxiety will be assessed at four predefined time points: in the waiting area (T0), immediately before transfer to the operating room (T1), in the operating room corridor (T2), and immediately before anesthesia induction (T3). Anxiety levels will be measured using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A). Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale at three time points: immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission to the post-anesthesia care unit (P2). The primary outcome of the study is the difference in preoperative anxiety levels between the two groups. Secondary outcomes include the incidence and severity of postoperative emergence delirium. The findings of this study may contribute to the development of simple, non-pharmacological strategies to improve perioperative psychological well-being and postoperative recovery in pediatric patients.

Interventions

OTHERToy car

Transfer to the operating room using a ride-on toy car.

OTHERStandard Transfer

Transfer to the operating room using a standard hospital stretcher.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
3 Years to 7 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Preoperative Anxiety LevelAssessments will be conducted in the waiting area, immediately before transfer to the operating room, during transport through the operating room corridor, and immediately before anesthesia induction.Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A) during the preoperative period. Preoperative anxiety will be assessed using m-YPAS, (score range 23-100) and VAS-A (score range 0-10), with higher scores indicating increased anxiety severity.

Secondary

MeasureTime frameDescription
Postoperative Emergence DeliriumFrom extubation through 30 minutes after admission to the post-anesthesia care unitEmergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium Scale (PAED; total score range 0-20). A score ≥10 will be considered indicative of emergence delirium, with higher scores reflecting greater severity.

Countries

Turkey (Türkiye)

Contacts

CONTACTFiliz Kaya, M.D
filiz.kaya17@saglik.gov.tr+90312552 60 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026