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

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

Study Overview

• Status: Recruiting
• Conditions: Preoperative Anxiety; Emergence Delirium in Pediatric Anesthesia
• Intervention / Treatment: Other: Hospital-Provided Doll; Other: Personal Doll; Other: No Doll

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Filiz Kaya, M.D; Phone Number: +903125526000; Email: filiz.kaya17@saglik.gov.tr

Study Locations

• Turkey (Türkiye)
  • ÇANKAYA
    • Ankara, ÇANKAYA, Turkey (Türkiye), 06800
      • Recruiting
      • Ankara Bilkent City Hospital
      • Contact: Filiz Kaya, M.D.; Phone Number: 03125526000; Email: filiz.kaya17@saglik.gov.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Female pediatric patients aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.

Description

Inclusion Criteria:

• Female children aged 3-7 years
• Scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia
• Able to communicate verbally
• ASA physical status I or II, according to the American Society of Anesthesiologists classification
• Written informed consent obtained from a parent or legal guardian

Exclusion Criteria:

• Presence of psychiatric, neurological, or developmental disorders
• Presence of chronic pain or ongoing medical treatment that may affect anxiety levels
• Refusal to participate despite repeated encouragement by the investigators
• Use of additional anxiety-reducing methods or medications outside the study protocol prior to intervention
• Previous surgical experience

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Hospital-Provided Doll; Participants will be accompanied by a hospital-provided doll during the preoperative period according to routine clinical practice.; Other Names: Hospital
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.	Other: Personal Doll; Participants will be accompanied by their own personal doll during the preoperative period based and routine practice.
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.	Other: No Doll; Participants will undergo the surgical process without the use of any doll.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Frenette G, Lessard C, Sullivan R. Selected proteins of "prostasome-like particles" from epididymal cauda fluid are transferred to epididymal caput spermatozoa in bull. Biol Reprod. 2002 Jul;67(1):308-13. doi: 10.1095/biolreprod67.1.308.
• Johnson H, Cowey A. Transneuronal retrograde degeneration of retinal ganglion cells following restricted lesions of striate cortex in the monkey. Exp Brain Res. 2000 May;132(2):269-75. doi: 10.1007/s002210000384.
• 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.
• Bienfait HM, Baas F, Gabreels-Festen AA, Koelman JH, Langerhorst CT, de Visser M. Two amino-acid substitutions in the myelin protein zero gene of a case of Charcot-Marie-Tooth disease associated with light-near dissociation. Neuromuscul Disord. 2002 Mar;12(3):281-5. doi: 10.1016/s0960-8966(01)00281-4.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Preoperative Anxiety; Emergence Delirium; Pediatric Anesthesia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Health Care Facilities Workforce and Services; Health Facilities; Hospitals
• Other Study ID Numbers: TABED 1-26-2055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data including demographic characteristics, group assignment, preoperative anxiety scores, and postoperative emergence delirium scores will be shared.
• IPD Sharing Time Frame: Beginning after publication of the primary results and continuing indefinitely.
• IPD Sharing Access Criteria: De-identified individual participant data and the study protocol will be shared with qualified researchers upon reasonable request and approval by the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No