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Recruiting Observational

Personal Versus Hospital-Provided Dolls in Preschool Children

NCT07403773 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-02-01
Last updated
2026-02-11

Condition(s) studied

Preoperative AnxietyEmergence Delirium in Pediatric Anesthesia

Investigational drug(s) / intervention(s)

Hospital-Provided DollPersonal DollNo Doll

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

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

No Doll: Participants will undergo the surgical process without the use of any doll.

Study 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

Eligibility

Sex
FEMALE
Min age
3 Years
Max age
7 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Preoperative Anxiety Level — Waiting area (T0), immediately before transfer to the operating room (T1), operating room corridor (T2), and just before anesthesia induction (T3)
    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.

Trial sites (1)

FacilityCityRegionStatus
Ankara Bilkent City Hospital Ankara ÇANKAYA Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07403773 on ClinicalTrials.gov ↗ ← All trials in Turkey