Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07403747
The goal of this clinical trial is to determine whether the method of transfer to the operating room can reduce preoperative anxiety and postoperative emergence delirium in male children aged 3 to 7 years undergoing elective adenoidectomy and/or tonsillectomy.
The main questions it aims to answer are:
* Does transfer using a ride-on toy car reduce preoperative anxiety compared with standard stretcher transfer? * Does this transfer method affect the incidence and severity of postoperative emergence delirium? Researchers will compare toy car transfer with standard hospital stretcher transfer to see if the toy car transfer is associated with lower anxiety levels and reduced emergence delirium.
Participants will:
* Transfer to the operating room either using a ride-on toy car or a standard hospital stretcher * Have preoperative anxiety assessed at predefined time points * Be evaluated for postoperative emergence delirium during recovery
Interested in participating?
Request Info3 year–7 year
Male
Observational
Ankara, 06800, Turkey (Türkiye)
Location status: Recruiting
This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. The study will include male children aged 3 to 7 years who are scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
Participants will be allocated into two groups. In Group 1, children will be transferred from the waiting area to the operating room using a ride-on toy car. In Group 2, children will be transferred using a standard hospital stretcher according to routine clinical practice. All other perioperative anesthesia management protocols will be standardized between groups.
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 immediately before anesthesia induction (T3). Anxiety levels will be measured using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A).
Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale at three time points: immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission to the post-anesthesia care unit (P2).
The primary outcome of the study is the difference in preoperative anxiety levels between the two groups. Secondary outcomes include the incidence and severity of postoperative emergence delirium. The findings of this study may contribute to the development of simple, non-pharmacological strategies to improve perioperative psychological well-being and postoperative recovery in pediatric patients.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transfer to the operating room using a ride-on toy car.
Transfer to the operating room using a standard hospital stretcher.
Time frame: Assessments will be conducted in the waiting area, immediately before transfer to the operating room, during transport through the operating room corridor, and immediately before anesthesia induction.
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.
Time frame: From extubation through 30 minutes after admission to the post-anesthesia care unit
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.
Contact information is provided by the study sponsor or research team.
Ankara City Hospital Bilkent
Other
Evaluation of the Effects of Ride-On Toy Car Use During Operating Room Transfer on Preoperative Anxiety and Postoperative Delirium in Preschool Children
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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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