Personal Versus Hospital-Provided Dolls in Preschool Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hospital-Provided Doll, Personal Doll, No Doll.
- Who it may be relevant to
- Registry conditions: Preoperative Anxiety, Emergence Delirium in Pediatric Anesthesia. Basic parameters: 3 years — 7 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Effects of Personal Versus Hospital-Provided Dolls on Preoperative Anxiety and Postoperative Delirium in Preschool Children
Overview
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.
Interventions
- 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.
Primary outcome measures
- Preoperative Anxiety Level [Time frame: Waiting area (T0), immediately before transfer to the operating room (T1), operating room corridor (T2), and just before anesthesia induction (T3)]
Secondary outcome measures (1)
- Postoperative Emergence Delirium [Time frame: Immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Turkey (Türkiye) · 1 center
- Ankara Bilkent City Hospital — Ankara
Publications
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07403773 · TABED 1-26-2055