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NCT Number: NCT07403773

Personal Versus Hospital-Provided Dolls 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

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Key information

Age range

3 year–7 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, ÇANKAYA, 06800, Turkey (Türkiye)

Location status: Recruiting

Location contact

Filiz Kaya, M.D.

CONTACT

[email protected]

03125526000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hospital-Provided Doll

Other

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

Other names: Hospital

Personal Doll

Other

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

No Doll

Other

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

Other names: Control

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Filiz Kaya, M.D

CONTACT

[email protected]

+903125526000

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of the Effects of Personal Versus Hospital-Provided Dolls on Preoperative Anxiety and Postoperative Delirium in Preschool Children

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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