B Kassai1, M Rabilloud2, E Dantony2, S Grousson3, O Revol4, S Malik5, T Ginhoux6, N Touil6, D Chassard7, E Pereira de Souza Neto8. 1. Service de Pharmacologie Clinique, EPICIME-CIC 1407 de Lyon, Inserm, CHU-Lyon, F-69677 Bron, France Université de Lyon, F-69000 Lyon, France Laboratoire de Biométrie et Biologie Evolutive, Université Lyon 1, CNRS, UMR 5558, F-69622 Villeurbanne, France behrouz.kassai@chu-lyon.fr. 2. Université de Lyon, F-69000 Lyon, France Laboratoire de Biométrie et Biologie Evolutive, Université Lyon 1, CNRS, UMR 5558, F-69622 Villeurbanne, France Service de Biostatistique, Hospices Civils de Lyon, F-69324 Lyon, France. 3. Department of Anaesthesioloy, Hôpital Neurologique Pierre Wertheimer, F-69677 Bron, France. 4. Department of Child and Adolescent Psychiatry. 5. Service de Pharmacologie Clinique, EPICIME-CIC 1407 de Lyon, Inserm, CHU-Lyon, F-69677 Bron, France Université de Lyon, F-69000 Lyon, France. 6. Service de Pharmacologie Clinique, EPICIME-CIC 1407 de Lyon, Inserm, CHU-Lyon, F-69677 Bron, France. 7. Department of Anaesthesioloy, Hôpital Femme-Mère-Enfant, F-69677 Bron, France. 8. Centre Hospitalier de Montauban, 100 rue Léon Cladel, 82013 Montauban, France Universidade do Oeste Paulista (UNOESTE), rua José Bongiovani, 700, 19050-920, Presidente Prudente, São Paulo, Brazil CNRS, Laboratoire de Physique, École Normale Supérieure de Lyon, 46, allée d'Italie, Cedex 07, Lyon 69364, France Department of Pediatric Anesthesia, Hôpital Sainte Justine, Montréal, QC, Canada.
Abstract
BACKGROUND: The aim of the study was to determine whether the introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety levels of children undergoing major surgery. Secondary objectives were to determine whether the level of understanding of participants and other risk factors influence STAIC-S (State-Trait Anxiety Inventory for Children-State subscale) score in children. METHODS: We performed a randomized controlled parallel-group trial comparing preoperative anxiety between two groups of children aged >6 and <17 yr. Before surgery, the intervention group received a comic information leaflet at home in addition to routine information given by the anaesthetist at least 1 day before surgery. The control group received the routine information only. The outcome measure was the difference between STAIC-S scores measured before any intervention and after the anaesthetist's visit. A multiple regression analysis was performed to explore the influence of the level of education, the anxiety of parents, and the childrens' intelligence quotient on STAIC-S scores. RESULTS:One hundred and fifteen children were randomized between April 2009 and April 2013. An intention-to-treat analysis on data from 111 patients showed a significant reduction (P=0.002) in STAIC-S in the intervention group (n=54, mean=-2.2) compared with the control group (n=57, mean=0.90). The multiple regression analysis did not show any influence on STAIC-S scores of the level of education, parental anxiety, or the intelligence quotient of the children. CONCLUSIONS: A paediatric anaesthesia comic information leaflet was a cheap and effective means of reducing preoperative anxiety, measured by STAIC-S, in children. CLINICAL TRIALS REGISTRATION: NCT 00841022.
RCT Entities:
BACKGROUND: The aim of the study was to determine whether the introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety levels of children undergoing major surgery. Secondary objectives were to determine whether the level of understanding of participants and other risk factors influence STAIC-S (State-Trait Anxiety Inventory for Children-State subscale) score in children. METHODS: We performed a randomized controlled parallel-group trial comparing preoperative anxiety between two groups of children aged >6 and <17 yr. Before surgery, the intervention group received a comic information leaflet at home in addition to routine information given by the anaesthetist at least 1 day before surgery. The control group received the routine information only. The outcome measure was the difference between STAIC-S scores measured before any intervention and after the anaesthetist's visit. A multiple regression analysis was performed to explore the influence of the level of education, the anxiety of parents, and the childrens' intelligence quotient on STAIC-S scores. RESULTS: One hundred and fifteen children were randomized between April 2009 and April 2013. An intention-to-treat analysis on data from 111 patients showed a significant reduction (P=0.002) in STAIC-S in the intervention group (n=54, mean=-2.2) compared with the control group (n=57, mean=0.90). The multiple regression analysis did not show any influence on STAIC-S scores of the level of education, parental anxiety, or the intelligence quotient of the children. CONCLUSIONS: A paediatric anaesthesia comic information leaflet was a cheap and effective means of reducing preoperative anxiety, measured by STAIC-S, in children. CLINICAL TRIALS REGISTRATION: NCT 00841022.
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