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

Abstract

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.Trial registrationClinicalTrials.gov identifier: NCT03324828. Registered 21 September 2017.

Effectiveness and cost-effectiveness of a lifestyle modification programme in the prevention and treatment of subclinical, mild and moderate depression in primary care: a randomised clinical trial protocol

“…Study limitations include the possible attrition of participants due to session scheduling or participant refusal to participate in a group intervention or do the complete follow-ups. 80 However, the possible reasons for attrition and other issues will be registered regarding MAGI framework. 38 …”

Natural arbovirus infection rate and detectability of indoor female Aedes aegypti from Mérida, Yucatán, Mexico

“…A randomized controlled clinical trial will evaluate the epidemiological impact of TIRS in Mérida [ 41 ], with ABV infection in Ae . aegypti being quantified as a secondary endpoint.…”

“…aegypti infection could be calculated as measures of intervention impact, provided they are accurately quantified (e.g., [ 23 ]). In preparation for a clinical trial evaluating the epidemiological impact of targeted indoor residual spraying (TIRS) on ABVs [ 41 ], here we extended an observational study that used exhaustive Prokopack collections in houses with suspected active virus transmission [ 18 ] to quantify absolute ABV infection rate in individual Ae . aegypti .…”

Evaluating ‘Enhancing Pragmatic Language skills for Young children with Social communication impairments’ (E-PLAYS): a feasibility cluster-randomised controlled trial

“…A vast number of commercially-available games are targeted at parents of children with autism spectrum disorders and other children with social communication impairments [ 81 ]. Reviewers [ 36 ] of the computer game literature have urgently called for large-scale studies to ensure that exploitation of the opportunities available with these new technologies is founded on a sound evidence-base to benefit the children to whom they are marketed.…”

“…The use of technology and gaming have been promoted as particularly useful means of facilitating communication and collaboration for children with communication difficulties as they are especially appealing to this group of children e.g. [ 34 – 36 ]. A systematic review and meta-analysis of computer-assisted collaborative learning [ 37 ] concluded that the intrinsic socio-cognitive scaffolding can enhance collaborative skills substantially; thus, computer games can facilitate communication and collaboration between children [ 38 – 40 ].…”