Not provided
Not provided
Not provided
Not provided
COVID-19
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxyzine+no clowns | Active Comparator | Patients will receive hydroxyzine solution and no additional intervention |
|
| Hydroxyzine+clowns | Experimental | Patients will receive hydroxyzine solution and clowns intervention |
|
| Placebo+clowns | Active Comparator | Patients will receive placebo solution and clowns intervention |
|
| Placebo+no clowns | No Intervention | Patients will receive placebo solution and no additional intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxyzine | Drug | Hydroxyzine solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| m-YPAS | Yale Preoperative Anxiety Scale (mYPAS) | Anxiety in the operation room (average 60 minutes from the begining of the study) |
| Measure | Description | Time Frame |
|---|---|---|
| m-YPAS | Yale Preoperative Anxiety Scale (mYPAS) | Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study) |
| Cortisol level (blood) | cortisol blood test |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Esther Aleo Lujan, MD | Hospital Clinico San Carlos | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34805403 | Derived | Aleo E, Picado AL, Abancens BJ, Soto Beauregard C, Tur Salamanca N, Esteban Polonios C, Torrejon MJ, Perrino CG, Rivas A, Arias E, Rodriguez D, Rivas MA, Rojo MLR, Garcia PF, Alarcon JR, San Pedro de Urquiza B. Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial. Biomed Res Int. 2021 Nov 11;2021:7394042. doi: 10.1155/2021/7394042. eCollection 2021. | |
| 31898511 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Clowns: outcomes assesor Hidroxicine: participant, care provider, investigator and outcomes assessor
| Clowns intervention |
| Other |
Clowns intervention |
|
| Just before starting surgery (average 75 minutes from the begining of the study) |
| Cortisol level (salive) | cortisol blood test | when the patient arrives at operation room(average 45 minutes from the begining of the study) |
| Anesthesia induction | Anesthesia induction according to the checklist | Just before starting surgery (average 75 minutes from the begining of the study) |
| Derived |
| Aleo Lujan E, Lopez-Picado A, Rivas A, Joyanes Abancens B, Rodriguez Rojo ML, Fernandez Garcia P, Soto Beauregard C, Rodriguez Alarcon J, Gonzalez Perrino C, San Pedro de Urquiza B, Arias E, Rodriguez D, Esteban Polonio C, Torrejon MJ. Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial. Trials. 2020 Jan 2;21(1):1. doi: 10.1186/s13063-019-3906-2. |