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dc.contributor.authorAleo Luján, Esther
dc.contributor.authorLopez-Picado, Amanda
dc.contributor.authorRivas, Ana
dc.contributor.authorJoyanes Abancens, Belén
dc.contributor.authorRodríguez Rojo, Marina Laura
dc.contributor.authorFernández García, Patricia
dc.contributor.authorSoto Beauregard, Carmen
dc.contributor.authorRodríguez Alarcón, Jaime
dc.contributor.authorGonzález Perrino, Carlos
dc.contributor.authorSan Pedro de Urquiza, Borja
dc.contributor.authorArias, Eva
dc.contributor.authorRodriguez, Diamelis
dc.contributor.authorEsteban Polonio, Carmen
dc.contributor.authorTorrejón, Maria José
dc.date.accessioned2021-01-14T08:13:06Z
dc.date.available2021-01-14T08:13:06Z
dc.date.issued2020
dc.identifier.issn1745-6215spa
dc.identifier.urihttp://hdl.handle.net/10641/2172
dc.description.abstractBackground Surgery 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. Methods We 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. Conclusions This 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.spa
dc.language.isoengspa
dc.publisherTrialsspa
dc.rightsAtribución-NoComercial-SinDerivadas 3.0 España*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/es/*
dc.subjectAnxietyspa
dc.subjectSurgeryspa
dc.subjectClownspa
dc.subjectHydroxyzinespa
dc.subjectRandomised clinical trialspa
dc.titlePre-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.spa
dc.typearticlespa
dc.description.versionpost-printspa
dc.rights.accessRightsopenAccessspa
dc.description.extent781 KBspa
dc.identifier.doi10.1186/s13063-019-3906-2spa
dc.relation.publisherversionhttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3906-2spa


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Atribución-NoComercial-SinDerivadas 3.0 España
Except where otherwise noted, this item's license is described as Atribución-NoComercial-SinDerivadas 3.0 España