RT Journal Article
T1 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
A1 Aleo Luján, Esther
A1 Lopez Picado, Amanda
A1 Rivas Paterna, Ana Belén
A1 Joyanes Albacens, Belen
A1 Rodríguez Rojo, Marina Laura
A1 Fernández García, Patricia
A1 Soto Beauregard, María Del Carmen
A1 Rodriguez Alarcon, Jaime
A1 Gonzalez Perrino, Carlos
A1 San Pedro de Urquiza, Borja
A1 Arias, Eva
A1 Rodriguez, Diamelis
A1 Esteban Polonio, Carmen
A1 Torrejon, Maria José
AB BackgroundSurgery can generate significant stress and anxiety in up to 70% of the paediatric population. There are several pharmacological and non-pharmacological strategies to reduce pre-operative anxiety in children, however, they have several side effects and the available information about them is contradictory. The role of clowns and hydroxyzine in the management of anxiety is controversial, with some studies supporting and others contraindicating both strategies.MethodsWe propose a randomised double-blind, controlled clinical trial that will evaluate the effectiveness of both interventions (hydroxyzine and clowns), alone or in combination, to reduce pre-operative anxiety (using the modified Yale scale of preoperative anxiety) in children aged 2–16 years undergoing outpatient surgery (n = 188).Subjects will be randomised into two groups – (1) standard procedure (parental accompaniment) combined with placebo or (2) standard procedure combined with preoperative hydroxyzine. After randomisation, they will be divided by chance into two further groups, depending on the presence of clowns on the patient’s surgery day. Control of pre-operative anxiety will be determined in the four groups by a modified Yale scale of preoperative anxiety and cortisol levels. Compliance of children during induction of anaesthesia, time until anaesthesia recovery, presence of postoperative delirium and use of analgesia until discharge will be also assessed. For additional information, the children, parents and healthcare professionals involved in the study will complete a satisfaction survey.ConclusionsThis study aims to gather evidence on which of these four therapeutic options achieves the highest reduction of pre-operative anxiety with the best safety profile to allow paediatricians and anaesthesiologists to use the most effective and safe option for their patients.
PB BMC
YR 2020
FD 2020-01-02
LK https://hdl.handle.net/20.500.14352/117477
UL https://hdl.handle.net/20.500.14352/117477
LA eng
NO Aleo Luján, E., Lopez-Picado, A., Rivas, A. et al. 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 21, 1 (2020). https://doi.org/10.1186/s13063-019-3906-2
DS Docta Complutense
RD 31 jul 2025