Anxiety
Conditions
Keywords
anxiety, surgery, clown
Brief summary
This study evaluate the change in preoperative anxiety, baseline (M1) and pre-induction anxiety levels (M3), as shown by children undergoing MAS determined by the m-YPAS scale in the different APO management groups.Patients will be allocated in one of this four groups: hydroxyzine+clown; hydroxyzine alone, clowns alone or nothing
Interventions
DRUGHydroxyzine
Hydroxyzine solution
OTHERClowns intervention
Clowns intervention
Sponsors
Hospital San Carlos, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Clowns: outcomes assesor Hidroxicine: participant, care provider, investigator and outcomes assessor
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children between 2 and 16 years old * Patients with programmed major ambulatory surgery. * Assessment of anesthetic risk ASA I-II. * Informed consent signed by their legal authorized representatives. * No antihistaminic allergies. * Assent signed by children between 12 and 16 years old.
Exclusion criteria
* Patients with previous surgeries. * Anesthetic risk ASA more than II. * Patients with hypersensitivity to the active substance, to any of the excipients, to cetirizine, to other piperazine derivatives, to aminophylline or etilenamida * Patients with porphyria * Patients with known QT prolongation, either congenital or acquired * Patients with known risk factors for QT prolongation including a pre-existing cardiovascular disease, previous electrolyte imbalances, family history of sudden cardiac death, significant bradycardia and concomitant use of drugs with potential known to produce QT prolongation and / or induce Torsades de Pointes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| m-YPAS | Anxiety in the operation room (average 60 minutes from the begining of the study) | Yale Preoperative Anxiety Scale (mYPAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol level (salive) | when the patient arrives at operation room(average 45 minutes from the begining of the study) | cortisol blood test |
| m-YPAS | Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study) | Yale Preoperative Anxiety Scale (mYPAS) |
| Cortisol level (blood) | Just before starting surgery (average 75 minutes from the begining of the study) | cortisol blood test |
| Anesthesia induction | Just before starting surgery (average 75 minutes from the begining of the study) | Anesthesia induction according to the checklist |
Countries
Spain
Outcome results
None listed