Ride-On Toy Car Use During Operating Room Transfer in Preschool Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age3-7
SponsorAnkara City Hospital Bilkent
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male children aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia
Ability to communicate verbally
American Society of Anesthesiologists (ASA) physical status I or II
Written informed consent obtained from a parent or legal guardian
Disqualifiers
Presence of psychiatric disorders, genetic diseases, neurological or developmental disorders
Chronic pain conditions or ongoing medical treatments that may affect anxiety levels
Refusal to participate despite repeated encouragement by the investigators
Use of additional anxiolytic interventions or medications prior to the intervention outside the study protocol
Trial population
Male pediatric patients aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Toy car
Other interventionTransfer to the operating room using a ride-on toy car.
Standard Transfer
Other interventionTransfer to the operating room using a standard hospital stretcher.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Toy Car Transfer1 intervention
Group B: Standard Stretcher Transfer1 intervention
Trial outcomes
Primary outcomes
1
Preoperative Anxiety Level
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
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.Secondary outcomes
1
Postoperative Emergence Delirium
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.
Time frame
From extubation through 30 minutes after admission to the post-anesthesia care unitSponsors and contacts
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Source ClinicalTrials.gov