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

NCT07403747 | Recruiting

• 1 other identifier: TABED 1-25-1794
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Preoperative Anxiety; Emergence Delirium in Pediatric Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Preoperative Anxiety Level

  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.

  Assessments 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.

Secondary Outcomes (1)

• Postoperative Emergence Delirium

  From extubation through 30 minutes after admission to the post-anesthesia care unit

Study Arms (2)

Toy Car Transfer

Participants will be transferred to the operating room using a ride-on toy car.

Other: Toy car

Standard Stretcher Transfer

Participants will be transferred to the operating room using a standard hospital stretcher

Other: Standard Transfer

Interventions

Toy car OTHER

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

Toy Car Transfer

Standard Transfer OTHER

Transfer to the operating room using a standard hospital stretcher.

Standard Stretcher Transfer

Eligibility Criteria

• Age: 3 Years - 7 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Male pediatric patients aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Vakili R, Feizi R, Salimi Y, Mottahedi M, Rizevandi P. Play dough or balloon blowing? A clinical trial comparing creative interventions for reducing preoperative anxiety in children aged 4-8 years. BMC Pediatr. 2025 May 15;25(1):384. doi: 10.1186/s12887-025-05718-1.

  PMID: 40375092 BACKGROUND

• Tang X, Zhang M, Yang L, Tao X, Li Y, Wang Y, Wang X, Hu X. Individual cartoon video for alleviating perioperative anxiety and reducing emergence delirium in children: a prospective randomised trial. BMJ Paediatr Open. 2023 Jul;7(1):e001854. doi: 10.1136/bmjpo-2023-001854.

  PMID: 37407252 BACKGROUND

• Park SH, Park S, Lee S, Choi JI, Bae HB, You Y, Jeong S. Effect of transportation method on preoperative anxiety in children: a randomized controlled trial. Korean J Anesthesiol. 2020 Feb;73(1):51-57. doi: 10.4097/kja.19191. Epub 2019 Jul 15.

  PMID: 31304694 BACKGROUND

• Pastene B, Piclet J, Praud C, Garcia K, Louis K, Schmidt C, Boyadjiev I, Boucekine M, Baumstarck K, Bezulier K, Bouvet L, Zieleskiewicz L, Leone M. Pre-operative distraction using electric ride-on cars for children undergoing elective ambulatory surgery: A randomised controlled trial. Eur J Anaesthesiol. 2023 Mar 1;40(3):190-197. doi: 10.1097/EJA.0000000000001758. Epub 2022 Oct 3.

  PMID: 36204923 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Filiz Kaya, M.D

CONTACT

+90312552 60 00; filiz.kaya17@saglik.gov.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 11, 2026
• Study Start: November 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning after publication of the primary results and continuing indefinitely.
• Access Criteria: De-identified individual participant data and the study protocol will be shared with qualified researchers upon reasonable request and approval by the principal investigator.

Locations

TU (1)