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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Toy car
  Transfer to the operating room using a ride-on toy car.
• Другое Standard Transfer
  Transfer to the operating room using a standard hospital stretcher.

Первичные конечные точки

• Preoperative Anxiety Level [Срок оценки: 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.]

Вторичные конечные точки (1)

• Postoperative Emergence Delirium [Срок оценки: From extubation through 30 minutes after admission to the post-anesthesia care unit]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Bilkent City Hospital — Ankara

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07403747 · TABED 1-25-1794

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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