Actively Recruiting

Age: 3Years - 7Years
FEMALE
Healthy Volunteers
ID07403773

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

Led by Ankara City Hospital Bilkent · Updated on 2026-02-11

120

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how the use of personal dolls versus hospital-provided dolls affects preoperative anxiety and postoperative delirium in female preschool children aged 3 to 7 years undergoing elective adenoidectomy and/or tonsillectomy under general anesthesia. The study aims to determine if either doll use is associated with lower anxiety levels before surgery and reduced incidence or severity of delirium after surgery. Participants are observed in three groups: those accompanied by a hospital-provided doll, those with their own personal doll, and those with no doll. During the study, children will be observed according to their group without any intervention assigned by investigators, maintaining standard perioperative care. Anxiety is assessed at four specific times before surgery using the modified Yale Preoperative Anxiety Scale and Visual Analog Scale for Anxiety. Serum cortisol, a stress marker, is measured during routine intravenous cannulation. Postoperative delirium is evaluated at three time points after surgery using the Pediatric Anesthesia Emergence Delirium Scale. Participants will undergo anxiety assessments in waiting areas and operating rooms, blood sample collection during routine care, and delirium assessments in the recovery unit. Researchers will compare anxiety scores, cortisol levels, and delirium scores among the three groups. The study provides insights into non-drug methods like doll use to reduce perioperative stress in young surgical patients. Participation lasts through the perioperative period with evaluations before and after surgery.

CONDITIONS

Brief Title

Personal Versus Hospital-Provided Dolls in Preschool Children

Who Can Participate

Age: 3Years - 7Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female children aged 3 to 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Monitoring

Duration - Day of surgery

Participants are observed during the preoperative and postoperative periods to assess anxiety levels and emergence delirium using standard assessment tools without any assigned intervention.

1 perioperative observation period including assessments at multiple time points before and after surgery

Trial Site Locations

Total: 1 location

1

Ankara Bilkent City Hospital

Ankara, ÇANKAYA, Turkey (Türkiye), 06800

Actively Recruiting

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Research Team

F

Filiz Kaya, M.D

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Play dough or balloon blowing? A clinical trial comparing creative interventions for reducing preoperative anxiety in children aged 4-8 years.

Razie Vakili, Reza Feizi, Yahya Salimi...

https://pubmed.ncbi.nlm.nih.gov/40375092

Exploring Novel Non-pharmacologic Approaches to Address Preoperative Anxiety and Postoperative Pain in Pediatric Patients Undergoing In-Patient Surgical Procedures: A Scoping Review.

Gabriela E Llerena, Emily Krzykwa, Michael Huzior...

https://pubmed.ncbi.nlm.nih.gov/38344516

The effect of augmented reality on preoperative anxiety in children and adolescents: A randomized controlled trial.

Cindy Chamberland, Myriam Bransi, Ariane Boivin...

https://pubmed.ncbi.nlm.nih.gov/37925608

The Role of Preoperative Virtual Reality for Anxiety Reduction in Pediatric Surgical Patients: A Systematic Review and Meta-Analysis.

Anas E Ahmed, Lojain I Daak, Mazen A Alayidh...

https://pubmed.ncbi.nlm.nih.gov/39917152