Personal versus hospital-provided dolls to comfort preschoolers during adenoidectomy or tonsillectomy
Comparison of the Effects of Personal Versus Hospital-Provided Dolls on Preoperative Anxiety and Postoperative Delirium in Preschool Children
Ankara City Hospital Bilkent · NCT07403773
This tests whether a child's own doll or a hospital-provided doll reduces preoperative anxiety and emergence delirium in 3–7-year-old girls having elective adenoidectomy or tonsillectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | Female |
| Sponsor | Ankara City Hospital Bilkent (other) |
| Locations | 1 site (Ankara, ÇANKAYA) |
| Trial ID | NCT07403773 on ClinicalTrials.gov |
What this trial studies
This is an observational comparison of three groups—children with a personal doll, children given a hospital-provided doll, and children with no doll—based on routine practice and parental preference. Preoperative anxiety is measured at four time points using the modified Yale Preoperative Anxiety Scale (m-YPAS) and a Visual Analog Scale for Anxiety (VAS-A), and serum cortisol is obtained from the routine IV sample as a stress biomarker. Postoperative emergence delirium is measured in the recovery period using a pediatric emergence delirium scale. All participants receive standard perioperative care and no interventions are assigned by investigators; the population is female children aged 3–7 undergoing elective adenoidectomy and/or tonsillectomy at a single center.
Who should consider this trial
Good fit: Female children aged 3–7 years who can speak, are ASA I–II, and are scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia with parental consent are the intended participants.
Not a fit: Children with psychiatric, neurological, or developmental disorders, chronic pain, prior surgical experience, or those using additional anxiolytic methods or medications are excluded and may not benefit from the doll-related findings.
Why it matters
Potential benefit: If successful, this could provide a simple, low-cost way to reduce preoperative anxiety and possibly lower rates or severity of emergence delirium in young children having these surgeries.
How similar studies have performed: Previous work suggests familiar objects and parental presence can reduce preoperative anxiety in children, but direct evidence that dolls reduce emergence delirium is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ankara, ÇANKAYA
- Ankara Bilkent City Hospital — Ankara, ÇANKAYA, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Filiz Kaya, M.D
- Email: filiz.kaya17@saglik.gov.tr
- Phone: +903125526000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preoperative Anxiety, Emergence Delirium in Pediatric Anesthesia, Emergence Delirium, Pediatric Anesthesia