NCT07403773

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: Female
• Age: 3 Years – 7 Years
• Healthy volunteers: Accepted

Summary

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: * Is the use of a personal doll or a hospital-provided doll associated with lower preoperative anxiety compared with no doll use? * Is dolls used associated with a reduced incidence and severity of postoperative emergence delirium? * Researchers will compare children accompanied by a hospital-provided doll, children accompanied by their personal doll, and children with no doll to assess differences in preoperative anxiety levels, serum cortisol concentrations, and postoperative delirium scores. Participants will: * Be observed in one of three exposure groups (hospital-provided doll, personal doll, or no doll) * Undergo standardized preoperative anxiety assessments at predefined time points * Have serum cortisol levels measured during routine intravenous cannulation * Be assessed for postoperative delirium in the recovery unit

Detailed description

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.

Conditions

• Preoperative Anxiety
• Emergence Delirium in Pediatric Anesthesia

Interventions

Type	Name	Description
OTHER	Hospital-Provided Doll	Participants will be accompanied by a hospital-provided doll during the preoperative period according to routine clinical practice.
OTHER	Personal Doll	Participants will be accompanied by their own personal doll during the preoperative period based and routine practice.
OTHER	No Doll	Participants will undergo the surgical process without the use of any doll.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: Turkey (Türkiye)