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INTRODUCTION: Anxiety in children triggered by a scheduled surgical intervention is a major issue due to its frequency and consequences. Preoperative anxiety is associated with increased patient fear and agitation on anesthetic induction. The aim of this study is to compare three preoperative anxiety scales for children undergoing elective outpatient surgery, and to correlate each of these tools with the degree of patient compliance on induction, as assessed by the Induction Compliance Checklist (ICC). METHODS: An observational prospective study was performed on a cohort of children with ages between 2 and 16 years old, scheduled for outpatient surgery. Anxiety was assessed upon arrival to the hospital (M0), during transfer to the surgical unit (M1), and in the operating room during anesthetic induction (M2). Anxiety in the parents (measured with the State-Trait Anxiety Inventory, STAI) and in the children (measured with the Spence Anxiety Scale-Pediatric, SCAS-P, the State-Trait Anxiety Inventory Children, STAIC, and Modified Yale Preoperative Anxiety Scale, m-YPAS) was assessed. Compliance with anesthetic induction was assessed with ICC. RESULTS: The study included 76 patients (72.4% male, median age 7.9 years). Anxiety scores (m-YPAS) increased as the moment of surgery approached, being greater at the entrance to the surgical unit (M0 = 26.1 ± 9.5; M1 = 31.8 ± 18.1; M2 = 33.5 ± 21.1). A strong correlation was found between ICC scale and m-YPAS at M1 (0.738) and M2 timepoints (0.794), but not with the rest of scales at M0. CONCLUSIONS: Standard anxiety assessment scales do not predict the quality of anesthetic induction. m-YPAS scale can detect increasing anxiety in children as they approach the surgical procedure and this correlates strongly with a worse anesthetic induction, defined by higher score on ICC scale.
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BACKGROUND: 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03324828. Registered 21 September 2017.
