A Phase 4 interventional study of Hydroxyzine and Clowns intervention in Anxiety, sponsored by Hospital San Carlos, Madrid. Terminated at 1 site in Spain. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-08-11.
Sponsored by Hospital San Carlos, Madrid · Phase 4, Interventional, and Treatment
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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
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 170 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Hospital San Carlos, Madrid is the lead sponsor of 74 studies on the registry; 17 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive hydroxyzine solution and no additional intervention
Drug: Hydroxyzine
Patients will receive hydroxyzine solution and clowns intervention
Drug: Hydroxyzine · Other: Clowns intervention
Patients will receive placebo solution and clowns intervention
Other: Clowns intervention
Patients will receive placebo solution and no additional intervention
Hydroxyzine solution
Clowns intervention
m-YPAS
Yale Preoperative Anxiety Scale (mYPAS)
Time frame: Anxiety in the operation room (average 60 minutes from the begining of the study)
m-YPAS
Yale Preoperative Anxiety Scale (mYPAS)
Time frame: Anxiety when the patient arrives at operation room (average 45 minutes from the begining of the study)
Cortisol level (blood)
cortisol blood test
Time frame: Just before starting surgery (average 75 minutes from the begining of the study)
Cortisol level (salive)
cortisol blood test
Time frame: when the patient arrives at operation room(average 45 minutes from the begining of the study)
Anesthesia induction
Anesthesia induction according to the checklist
Time frame: Just before starting surgery (average 75 minutes from the begining of the study)
Ran from Nov 2017 to primary completion in May 2020, 30 months.
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This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydroxyzine
Hospital San Carlos, Madrid