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The goal of this study is to evaluate the effects of personal versus hospital-provided dolls on preoperative anxiety and postoperative delirium in preschool children aged 3-7 years undergoing elective adenoidectomy and/or tonsillectomy.
The main questions it aims to answer are:
Participants will:
This study is designed to evaluate the association between doll use and preoperative anxiety as well as postoperative emergence delirium in preschool children undergoing elective adenoidectomy and/or tonsillectomy. The study population consists of female children aged 3-7 years who meet the eligibility criteria and are scheduled for elective surgery under general anesthesia.
Participants will be observed in one of three exposure groups based on routine perioperative practice and parental preference: children accompanied by a hospital-provided doll, children accompanied by their personal doll, and children with no doll use. No intervention will be assigned by the investigators, and standard perioperative care will be maintained for all participants.
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 just before anesthesia induction (T3). Anxiety levels will be evaluated using the modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A).
As a biochemical marker of stress response, serum cortisol levels will be measured from an additional blood sample obtained during routine intravenous cannulation performed for clinical purposes. No additional invasive procedures will be required for study-related assessments.
Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium Scale (PAED) at three points: immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2).
The study aims to provide clinical evidence regarding the potential role of non-pharmacological, easily applicable strategies such as doll use in reducing perioperative anxiety and postoperative delirium in pediatric surgical patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospital-Provided Doll Group | Participants in this cohort will consist of preschool children accompanied by a hospital-provided doll during the preoperative period. Preoperative anxiety levels, serum cortisol concentrations, and postoperative emergence delirium will be assessed as part of routine perioperative observation. |
| |
| Personal Doll Group | Participants in this cohort will consist of preschool children accompanied by their own personal doll during the preoperative period. Preoperative anxiety levels, serum cortisol concentrations, and postoperative emergence delirium will be evaluated using standardized assessment tools. |
| |
| No Doll (Control) Group | Participants in this cohort will consist of preschool children who will undergo the surgical process without the use of any doll. Preoperative anxiety, serum cortisol levels, and postoperative emergence delirium will be observed and recorded for comparison purposes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospital-Provided Doll | Other | Participants will be accompanied by a hospital-provided doll during the preoperative period according to routine clinical practice. |
|
| 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. | Waiting area (T0), immediately before transfer to the operating room (T1), operating room corridor (T2), and just before anesthesia induction (T3) |
| 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. | Immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2) |
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Inclusion Criteria:
Exclusion Criteria:
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Female 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 | +903125526000 | filiz.kaya17@saglik.gov.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Recruiting | Ankara | ÇANKAYA | 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. | |
| 38344516 | Background | Llerena GE, Krzykwa E, Huzior M, Vilar N, Donahue D, Zisling H, Zielinski P, Shah N, Lewandowski T, Dennison S, Alonso N. Exploring Novel Non-pharmacologic Approaches to Address Preoperative Anxiety and Postoperative Pain in Pediatric Patients Undergoing In-Patient Surgical Procedures: A Scoping Review. Cureus. 2024 Jan 10;16(1):e52006. doi: 10.7759/cureus.52006. eCollection 2024 Jan. |
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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 | Jan 14, 2026 | 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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| ID | Term |
|---|---|
| D006761 | Hospitals |
| ID | Term |
|---|---|
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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|
| Personal Doll | Other | Participants will be accompanied by their own personal doll during the preoperative period based and routine practice. |
|
| No Doll | Other | Participants will undergo the surgical process without the use of any doll. |
|
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| 37925608 | Background | Chamberland C, Bransi M, Boivin A, Jacques S, Gagnon J, Tremblay S. The effect of augmented reality on preoperative anxiety in children and adolescents: A randomized controlled trial. Paediatr Anaesth. 2024 Feb;34(2):153-159. doi: 10.1111/pan.14793. Epub 2023 Nov 4. |
| 39917152 | Background | Ahmed AE, Daak LI, Alayidh MA, Filfilan RR, Alathath RM, Rehbini AA, Alshabrami TA, Alqahatani SA, Alzahrani RA, Althobaiti HS. The Role of Preoperative Virtual Reality for Anxiety Reduction in Pediatric Surgical Patients: A Systematic Review and Meta-Analysis. Cureus. 2025 Jan 7;17(1):e77077. doi: 10.7759/cureus.77077. eCollection 2025 Jan. |
| 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 |