NCT07403773|Recruiting
Personal Versus Hospital-Provided Dolls in Preschool Children
Comparison of the Effects of Personal Versus Hospital-Provided Dolls on Preoperative Anxiety and Postoperative Delirium in Preschool Children
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Comparison of the Effects of Personal Versus Hospital-Provided Dolls on Preoperative Anxiety and Postoperative Delirium in Preschool Children
Sponsor study identifier
observational
120
1 country
1
Study Start
February 1, 2026
Actual (reported)Primary Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2026
Actual (reported)February 5, 2026
Actual (reported)February 11, 2026
Actual (reported)June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
Postoperative Emergence Delirium
Immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2)
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.
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.
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.
Participants will be accompanied by a hospital-provided doll during the preoperative period according to routine clinical practice.
Participants will be accompanied by their own personal doll during the preoperative period based and routine practice.
Female pediatric patients aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
Ankara Bilkent City Hospital
Ankara, ÇANKAYA, 06800, Turkey (Türkiye)
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.
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.
First Submitted
February 5, 2026
First Posted
February 11, 2026
Study Start
February 1, 2026
Actual (reported)Primary Completion
June 30, 2026
Estimated (date passed)The Effect of Laughter Yoga on Preoperative Anxiety in Pediatric Patients
Participants will undergo the surgical process without the use of any doll.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 11, 2026
Record last verified: 2026-02
De-identified individual participant data including demographic characteristics, group assignment, preoperative anxiety scores, and postoperative emergence delirium scores will be shared.
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Source: ClinicalTrials.gov.
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