Personal Versus Hospital-Provided Dolls in Preschool Children

NCT07403773 | Recruiting

• 1 other identifier: TABED 1-26-2055
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Preoperative Anxiety; Emergence Delirium in Pediatric Anesthesia

Keywords

Preoperative Anxiety; Emergence Delirium; Pediatric Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative Emergence Delirium

  Immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2)

Study Arms (3)

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

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

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

Interventions

Hospital-Provided Doll OTHER

Participants will be accompanied by a hospital-provided doll during the preoperative period according to routine clinical practice.

Also known as: Hospital

Hospital-Provided Doll Group

Personal Doll OTHER

Participants will be accompanied by their own personal doll during the preoperative period based and routine practice.

Personal Doll Group

No Doll OTHER

Participants will undergo the surgical process without the use of any doll.

Also known as: Control

No Doll (Control) Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, ÇANKAYA, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 40375092 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.

  PMID: 38344516 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.

  PMID: 37925608 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.

  PMID: 39917152 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Interventions

Hospitals

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Central Study Contacts

Filiz Kaya, M.D

CONTACT

+903125526000; filiz.kaya17@saglik.gov.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 11, 2026
• Study Start: February 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning after publication of the primary results and continuing indefinitely.
• 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.

Locations

TU (1)