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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toy Car Transfer | Participants will be transferred to the operating room using a ride-on toy car. |
| |
| Standard Stretcher Transfer | Participants will be transferred to the operating room using a standard hospital stretcher |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toy car | Other | Transfer to the operating room using a ride-on toy car. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Emergence Delirium | Emergence 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. | From extubation through 30 minutes after admission to the post-anesthesia care unit |
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Inclusion Criteria:
Exclusion Criteria:
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Male pediatric patients aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Filiz Kaya, M.D | Contact | +90312552 60 00 | filiz.kaya17@saglik.gov.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40375092 | Background | 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. | |
| 37407252 | 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. |
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De-identified individual participant data including demographic characteristics, group assignment, preoperative anxiety scores, and postoperative emergence delirium scores will be shared.
Beginning after publication of the primary results and continuing indefinitely.
De-identified individual participant data and the study protocol will be shared with qualified researchers upon reasonable request and approval by the principal investigator.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 22, 2025 | Feb 5, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| Standard Transfer |
| Other |
Transfer to the operating room using a standard hospital stretcher. |
|
| 31304694 | 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. |
| 36204923 | 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. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |