Personal Versus Hospital-Provided Dolls in Preschool Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age3-7
SponsorAnkara City Hospital Bilkent
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Female 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
Hospital-Provided Doll
Other interventionParticipants will be accompanied by a hospital-provided doll during the preoperative period according to routine clinical practice.
Personal Doll
Other interventionParticipants will be accompanied by their own personal doll during the preoperative period based and routine practice.
No Doll
Other interventionParticipants will undergo the surgical process without the use of any doll.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Hospital-Provided Doll Group1 intervention
Group B: Personal Doll Group1 intervention
Group C: No Doll (Control) Group1 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
Waiting area (T0), immediately before transfer to the operating room (T1), operating room corridor (T2), and just before anesthesia induction (T3)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
Immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2)Sponsors and contacts
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Source ClinicalTrials.gov