Recentes evidências sugerem que a dor lombar crônica está associada a alterações plásticas no cérebro, que podem ser modificadas por estratégias de neuromodulação. Neste ensaio clínico investigamos a eficácia analgésica de 12 sessões não consecutivas de estimulação transcraniana por corrente contínua (ETCC), estimulação elétrica periférica (EEP), ETCC+EEP e estimulação simulada (sham) em 92 pacientes com dor lombar crônica inespecífica. A intensidade, aspecto sensorial e afetivo da dor, incapacidade e percepção global de recuperação foram avaliadas antes do tratamento e quatro semanas, três e seis meses pós-randomização. Efeitos adversos, satisfação do paciente com o tratamento e fatores de confusão como ansiedade e depressão também foram avaliados. Os resultados demonstraram efeitos analgésicos clinicamente importantes da ETCC+EEP (MD = -2,6 IC95% = -4,4 a -0,9) e EEP isolada (MD = -2,2 IC95% = -3,9 a -0,4) comparada ao grupo sham, mas não da ETCC isolada (MD = -1,7 IC95% = -3,4 a -0,0). Além da manutenção do efeito analgésico por até três meses a ETCC+EEP obteve maior proporção de respondedores em diferentes pontos de corte. Os resultados sugerem que tanto a ETCC+EEP quanto EEP isolada são eficazes em curto prazo para o alívio da dor lombar crônica inespecífica. No entanto o efeito analgésico mais duradouro aliado a maior proporção de respondedores indicam um possível efeito aditivo e sinérgico da ETCC+EEP no alívio da dor em pacientes com dor lombar crônica não específica. Os nossos resultados não apoiam o uso da ETCC no regime de tratamento utilizado / Recent evidence suggests that chronic low back pain is associated with plastic changes in the brain that can be modified by neuromodulation strategies. In this clinical trial we have investigated the analgesic efficacy of 12 non-consecutive sessions of transcranial direct current stimulation (tDCS), peripheral electrical stimulation (PES), tDCS+PES and sham stimulation in 92 patients with chronic nonspecific low back pain. Intensity, the sensory and affective aspect of pain, disability, and overall perception of recovery were assessed before treatment and four weeks, three and six months post-randomization. Adverse effects, patient satisfaction with treatment and confounding factors such as anxiety and depression were also evaluated. The results showed clinically significant analgesic effects of tDCS+PES (Mean Reduction (MR) = -2.6; CI95% = -4.4 to - 0.9) and PES alone (MD = -2.2, CI95% = -3.9 to -0.4) compared to sham group, but not tDCS alone (MD = -1.7, CI95% = -3.4 to -0.0). In addition to maintaining the analgesic effect for up to three months, tDCS+PES treatment had a higher proportion of responders in different cutoff points. The results suggest that both tDCS+PES and PES alone are effective in relieving chronic nonspecific low back pain in the short term. However the most lasting analgesic effect, combined with a higher proportion of responders, indicates a possible additive and synergistic effect of tDCS+PES in relieving low back pain. Our findings do not support the use of tDCS alone in this condition

Introdução: O presente estudo tem como objetivo avaliar a eficácia da estimulação magnética transcraniana de repetição (EMTr) em freqüência excitatória, aplicada ao córtex pré-frontal dorsolateral direito (CPFDLd), quando adicionada ao tratamento vigente de pacientes com transtorno obsessivocompulsivo (TOC) resistente. Método: 30 pacientes com TOC resistente ao tratamento foram alocados aleatoriamente para receber EMTr ativa ou placebo, sendo que a condição de tratamento permaneceu oculta para pacientes e avaliador. O tratamento vigente permaneceu estável por ao menos 8 semanas. A EMTr foi realizada com uma bobina em formato de oito à freqüência de 10Hz, com 110% do limiar motor em 30 sessões diárias de 40 séries de 5 segundos com 25 segundos de intervalo. A gravidade dos sintomas foi avaliada inicialmente, após 2 e 6 semanas de tratamento e 2 e 6 semanas de seguimento com a escala de Yale-Brown para avaliação de sintomas obsessivo-compulsivos (Y-BOCS), Escala de Impressão Clínica Global (CGI), Escala de Hamilton para ansiedade (HAM-A), Escala de Hamilton para depressão com 17 itens (HAM-D17), e inventário SF-36 de qualidade de vida. A medida primária de eficácia foi definida como redução de 30% ou mais nos escores da Y-BOCS e avaliação melhor ou muito melhor na sub-escala de melhora clínica da CGI ao término do seguimento. Resultados: A análise da medida primária de eficácia revelou que apenas um paciente em cada grupo preencheu critérios de resposta para o tratamento com EMTr (P=1.00). A análise de medidas repetidas dos escores de Y-BOCS mostrou um efeito significativo do tempo (F=7.33, P=0.002). Entretanto, não foi observada diferença entre os grupos ou interação grupo/tempo. A análise de medidas repetidas da CGI (gravidade), HAM-D17 e HAM-A também mostrou efeito significativo do tempo (P<0.001, =0.001 e <0.001 respectivamente), novamente sem diferença significativa entre os grupos ou interação. Conclusão: EMTr excitatória aplicada ao CPFDLd de pacientes com TOC resistente ao tratamento não foi diferente de placebo na redução de sintomas obsessivo-compulsivos ou melhora da impressão clínica global. Entretanto, ocorreu uma resposta placebo significativa / Introduction: The present study aims to evaluate the efficacy of added excitatory repetitive transcranial magnetic stimulation (rTMS), applied to the right dorsolateral prefrontal cortex in patients with treatment resistant obsessive-compulsive disorder (OCD). Methods: 30 treatment resistant OCD outpatients were randomized to receive either active or sham rTMS, remaining both patients and rater blind to treatment condition. Baseline treatment was kept stable for at least 8 weeks, and rTMS was performed with a figure-of-eight coil at 10Hz, 110% of motor threshold at 30 daily sessions of 40 trains of 5 seconds with 25 seconds interval. Symptom severity was determined at baseline and after 2 and 6 weeks of treatment and further 2 and 6 weeks of follow-up, using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Clinical Global Impression Scale (CGI), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D17) and SF-36 quality of life inventory. The primary outcome measure was defined as 30% or more improvement in Y-BOCS scores and a much improved or improved score at the CGIimprovement subscale by the end of follow up. Results: The analysis of primary outcome measure revealed that only one patient on each group met response criteria for treatment with rTMS (P=1.00). Repeated-measures analysis of Y-BOCS scores showed a significant effect of time (F=7.33, P=0.002). However, no significant group effect or group by time interaction was observed. Repeated measures analysis of CGI (severity), HAM-D17 and HAM-A also showed a significant effect of time (P<0.001, =0.001 and <0.001 respectively) with no significant group effect or group by time interaction. Conclusion: Excitatory rTMS delivered to the rDLPFC of treatment resistant OCD patients was not different from placebo in reducing obsessive-compulsive symptoms or improving clinical global impression. However, a significant placebo response occurred

INTRODUÇÃO: A incapacidade física e psicológica, incluindo o medo de quedas, está relacionada à diminuição da satisfação com a vida na osteoporose (OP). O impacto de um programa de treino de equilíbrio para melhorar a qualidade de vida não está bem estabelecido. O objetivo deste estudo, portanto, foi investigar a eficácia que um programa de treino de equilíbrio, realizado durante um período de 12 meses, pôde provocar na qualidade de vida, no equilíbrio funcional e nas quedas em mulheres idosas com osteoporose. MÉTODOS: Sessenta mulheres com OP senil (idade: 65 a 85 anos) do Ambulatório de Doenças Osteometabólicas foram randomizadas e divididas em 2 grupos: Grupo Equilíbrio (GE) 30 pacientes que realizaram intervenção e Grupo Controle (GC) 30 pacientes sem intervenção. O programa de treino de equilíbrio incluiu técnicas para melhorar o equilíbrio durante o período de 12 meses (1sessão de 1h/semana de exercícios complementados com exercícios feitos em casa). A qualidade de vida foi avaliada antes e no final do estudo utilizando o questionário Osteoporosis Assessment Questionnaire (OPAQ), o equilíbrio funcional foi avaliado pela escala Berg Balance Scale (BBS). As quedas no ano anterior foram anotadas e comparadas durante o período de estudo. RESULTADOS: A comparação dos domínios do OPAQ (INICIAL - FINAL) revelou uma melhora significativa da qualidade de vida em todos os parâmetros do GE em relação ao GC: bem-estar geral (1,61 ± 1,44 vs. -1,46 ± 1,32, p <0,001), função física (1,30 ± 1,33 vs. -0,36 ± 0,82, p<0,001), estado psicológico (1,58 ± 1,36 vs. -1,02 ± 0,83, p <0,001), sintomas (2,76 ± 1,96 vs. -0,63 ± 0,87, p <0,001), interação social (1,01 ± 1,51 vs. 0,35 ± 1,08, p <0,001). Esse benefício global foi acompanhado por uma melhora da escala de equilíbrio BBS (-5,5 ± 0,5 vs. 5,67 ± 4,88 p <0,001) e da redução das quedas em 50% no GE vs. 26,6% para o GC (RR: 1,88, p <0,025). CONCLUSÃO: O programa de treino de equilíbrio para mulheres com OP, realizado por 12 meses, proporcionou uma melhor qualidade de vida e uma melhora no estado de saúde global paralelamente aos benefícios no equilíbrio funcional e na redução das quedas / INTRODUCTION: Physical and psychological incapacity, including fear of falling is related to decreased satisfaction with life in osteoporosis (OP). The impact of a balance exercise programs on improving the quality of life is not well established. We have, therefore, investigated the effect of 12-month Balance Training Program in quality of life, functional balance and falls in elderly OP women. METHODS: Sixty consecutive women with senile OP were randomized into a Balance Training Group (BT) of 30 patients and no intervention control group (CG) of 30 patients. The BT program included techniques to improve balance over a period of 12 months (1h exercise session/week and home-based exercises). The quality of life was evaluated before and at the end of the trial using the Osteoporosis Assessment Questionnaire (OPAQ), functional balance was evaluated by Berg Balance Scale (BBS). Falls in the preceding year were noted and compared to the period of study. RESULTS: The comparison of OPAQ variations (INITIAL-FINAL) revealed a significant improvement in quality of life in all parameters for BT compared to CG: well-being (1.61 ± 1.44 vs. -1.46 ± 1.32, p<0001), physical function (1.30 ± 1.33 vs. 0.36 ± 0.82, p<0.001), psychological status (1.58 ± 1.36 vs. 1.02 ± 0.83, p<0.001), symptoms (2.76 ± 1.96 vs. 0.63 ± 0.87, p<0.001), social interaction (1.01 ± 1.51 vs. 0.35 ± 1.08, p<0.001). Of note, this overall benefit was paralleled by an improvement of BBS (-5.5 ± 5.67 vs. +0.5 ± 4.88 p<0.001) and a reduction of falls in 50% in BT group vs. 26.6% for the CG (RR: 1.88, p<0.025). CONCLUSION: The long-term Balance Training Program of OP women provides a striking overall health quality of life improvement in parallel with improving functional balance and reduced falls

<p>Enthusiasm for uvulopalatopharyngoplasty (UPPP) in the treatment of mild-to-moderate obstructive sleep apnea syndrome (OSAS) has declined in recent years, partly because of a lower success rate over time and partly because of adverse effects. In more severe cases, the patients are generally treated with nasal continuous positive airway pressure (CPAP). However, many patients do not satisfactorily tolerate CPAP as a result of frequent side-effects. Consequently, there is a need for an alternative treatment. Reports on the beneficial effects of mandibular advancement appliances in the treatment of mild-to-moderate OSA exist in the form of short–term evaluations.</p><p>One of the aims of the present thesis was to compare treatment effects with a mandibular advancement appliance and UPPP in patients with OSA with follow-up after one and four years. Ninety-five male patients with confirmed mild-to-moderate OSA (apnea index, AI >5 and <25) were randomised to treatment with a dental appliance or UPPP. Sleep studies were performed before and one and four years after intervention. According to the criteria for normalisation (AI<5 and apnea hypopnea index, AHI<10), 78% of the patients in the dental appliance group and 51% of the patients in the UPPP group had normalised after one year (p<0.05). Still after four years of treatment, 63% of the patients in the dental appliance group and 33% of the patients in the UPPP group were normalised. The dental appliance group had a higher normalisation rate than the UPPP group, but the efficacy was partly invalidated by the compliance rate of 62%.</p><p>Quality of life assessments in the dimensions of vitality, contentment and sleep improved in both groups at the one-year follow-up after treatment. There was no difference between the groups in terms of vitality and sleep. The UPPP group, however, reported a higher degree of contentment than the dental appliance group, even though the somnographic values were superior in the latter group. </p><p>Another aim was to conduct a randomised study to test the hypothesis that severe OSA patients will benefit from more pronounced mandibular advancement (MA) compared with a shorter advancement. Eighty-six males with severe OSA (AI>20) were randomly allocated to either 75% or 50% MA for a six-month treatment period. Treatment with a more pronounced mandibular advancement yielded a 20% higher normalisation rate than a shorter advancement. A mean normalisation rate of 45% was found for patients in this category with few side-effects, good patient satisfaction and a compliance of 92% after 6 months. </p><p>The overall conclusion is that dental appliance treatment is effective in patients with mild to moderate OSA and even for patients with severe OSA. The efficacy in terms of normalisation in patients with mild to moderate OSA was higher after the dental appliance treatment with a 50% degree of advancement than after the UPPP treatment. However, severe OSA patients might benefit from more pronounced advancement (75%) compared with a shorter degree of advancement (50%). QOL improved significantly after both dental appliance and UPPP treatment. </p>

Background Due to small iron stores and rapid growth during the first months of life, infants with low birth weight (LBW) are at risk of iron deficiency (ID). ID in infancy is associated with irreversible impaired neurodevelopment. Preventive iron supplementation may reduce the risk of ID and benefit neurodevelopment, but there is also a possible risk of adverse effects. More than 50% of all LBW infants are born with marginally LBW (MLBW, 2000-2500g), and it is not known if they benefit from iron supplementation. Methods We randomized 285 healthy, Swedish, MLBW infants to receive 3 different doses of oral iron supplements; 0 (Placebo), 1, and 2 mg/kg/day from six weeks to six months of age. Iron status, during and after the intervention was assessed and so was the prevalence of ID and ID anemia (IDA), growth, morbidity and the interplay with iron and the erythropoetic hormones hepcidin and erythropoietin (EPO). As a proxy for conduction speed in the developing brain, auditory brainstem response (ABR) was analyzed at six months. In a follow up at 3.5 years of age, the children were assessed with a cognitive test (WPPSI-III) and a validated parental checklist of behavioral problems (CBCL), and compared to a matched reference group of 95 children born with normal birth weight. Results At six months of age, the prevalence of ID and IDA was significantly higher in the placebo group compared to the iron supplemented infants. 36% had ID in the placebo group, compared to 8% and 4 % in the 1 and 2mg/kg/day-groups, respectively. The prevalence of IDA was 10%, 3% and 0%, respectively. ABR-latencies did not correlate with the iron intake and was not increased in infants with ID or IDA. ABR wave V latencies were similar in all three groups. Hepcidin correlated to ferritin and increased in supplemented infants while EPO, which was negatively correlated to iron status indicators, decreased. At follow up there were no differences in cognitive scores between the groups but the prevalence of behavioral problems was significantly higher in the placebo group compared to those supplemented and to controls. The relative risk increase of CBCL-scores above a validated cutoff was 4.5 (1.4 – 14.2) in the placebo-group compared to supplemented children. There was no detected difference in growth or morbidity at any age. Conclusion MLBW infants are at risk of ID in infancy and behavioral problems at 3 years of age. Iron supplementation at a dose of 1-2 mg/kg/day from six weeks to six months of age reduces the risks with no adverse effects, suggesting both short and long term benefit. MLBW infants should be included in general iron supplementation programs during their first six months of life.

Enthusiasm for uvulopalatopharyngoplasty (UPPP) in the treatment of mild-to-moderate obstructive sleep apnea syndrome (OSAS) has declined in recent years, partly because of a lower success rate over time and partly because of adverse effects. In more severe cases, the patients are generally treated with nasal continuous positive airway pressure (CPAP). However, many patients do not satisfactorily tolerate CPAP as a result of frequent side-effects. Consequently, there is a need for an alternative treatment. Reports on the beneficial effects of mandibular advancement appliances in the treatment of mild-to-moderate OSA exist in the form of short–term evaluations. One of the aims of the present thesis was to compare treatment effects with a mandibular advancement appliance and UPPP in patients with OSA with follow-up after one and four years. Ninety-five male patients with confirmed mild-to-moderate OSA (apnea index, AI &gt;5 and &lt;25) were randomised to treatment with a dental appliance or UPPP. Sleep studies were performed before and one and four years after intervention. According to the criteria for normalisation (AI&lt;5 and apnea hypopnea index, AHI&lt;10), 78% of the patients in the dental appliance group and 51% of the patients in the UPPP group had normalised after one year (p&lt;0.05). Still after four years of treatment, 63% of the patients in the dental appliance group and 33% of the patients in the UPPP group were normalised. The dental appliance group had a higher normalisation rate than the UPPP group, but the efficacy was partly invalidated by the compliance rate of 62%. Quality of life assessments in the dimensions of vitality, contentment and sleep improved in both groups at the one-year follow-up after treatment. There was no difference between the groups in terms of vitality and sleep. The UPPP group, however, reported a higher degree of contentment than the dental appliance group, even though the somnographic values were superior in the latter group. Another aim was to conduct a randomised study to test the hypothesis that severe OSA patients will benefit from more pronounced mandibular advancement (MA) compared with a shorter advancement. Eighty-six males with severe OSA (AI&gt;20) were randomly allocated to either 75% or 50% MA for a six-month treatment period. Treatment with a more pronounced mandibular advancement yielded a 20% higher normalisation rate than a shorter advancement. A mean normalisation rate of 45% was found for patients in this category with few side-effects, good patient satisfaction and a compliance of 92% after 6 months. The overall conclusion is that dental appliance treatment is effective in patients with mild to moderate OSA and even for patients with severe OSA. The efficacy in terms of normalisation in patients with mild to moderate OSA was higher after the dental appliance treatment with a 50% degree of advancement than after the UPPP treatment. However, severe OSA patients might benefit from more pronounced advancement (75%) compared with a shorter degree of advancement (50%). QOL improved significantly after both dental appliance and UPPP treatment.

Introduction: Les instillations nasales de solution saline isotonique (INSS) chez les enfants sont recommandées par les pédiatres et des oto-rhino-laryngologistes de notre institution dans le but de prévenir les otites moyennes aigues à répétition (OMAr). Cependant, aucune étude dans la littérature ne vient corroborer ou infirmer cette pratique. Objectifs: Déterminer l’efficacité des INSS dans la prévention des OMAr. Méthode: Projet pilote d’un essai clinique randomisé. Les enfants diagnostiqués avec des OMAr étaient éligibles. Les patients recrutés ont été randomisés en 2 groupes. Seul le groupe traitement procède aux INSS. L’issue primaire est l’incidence d’OMAr pendant une période de 3 mois. Résultats: Vingt-neuf patients satisfaisant les critères d’inclusion et d’exclusion ont consenti à participer. Le taux d’OMAr était inférieur dans le groupe traitement (p=0.03, chi-carré) Conclusion: Les INSS semblent efficaces dans la prévention des OMAr. Une étude multicentrique est indiquée pour vérifier la validité externe et confirmer la sécurité. / Introduction: Normal saline nasal cavity irrigations (NSNI) are commonly recommended by pediatricians and otolaryngologists to prevent recurrent acute otitis media (rAOM). However, no published scientific study corroborates or invalidates this practice. Goal: To determine the efficacy of NSNI to prevent rAOM. Method: Pilot randomized controlled clinical trial. All consecutive patients with a diagnosis of rAOM were eligible. Recruited patients were randomized in 2 groups. Only patients in the treatment group proceeded with NSNI. The primary outcome of the study was the incidence of rAOM observed during a 3 month period. Results: Twenty-nine patients met the inclusion and exclusion criteria and agreed to participate. There was a statistically significant lower incidence of rAOM in the treatment group (p=0.003, Fisher exact). Conclusion: Our results suggest that NSNI could effectively prevent rAOM. A larger scale randomized multicentre study is feasible, and it must be done in order to verify for external validity and to properly assess safety issues.

Objectifs: Observer l’évolution de la stomatite prothétique dans le temps quant à la fréquence et la sévérité ainsi que son association avec de potentiels facteurs de risque au cours d’un suivi longitudinal de 2 ans. Matériels et méthodes : Cent trente-cinq patients âgés complètement édentés et en bonne santé ont été sélectionnés pour participer à cette étude et ont été divisés de façon randomisée en deux groupes. Ils ont tous reçu une prothèse dentaire amovible totale conventionnelle au maxillaire supérieur. La moitié d’entre eux a reçu une prothèse totale mandibulaire implanto-portée retenue par deux attachements boule et l’autre moitié une prothèse conventionnelle. Ils ont été suivis sur une période de deux ans. Les données sociodémographiques, d’habitudes de vie, d’hygiène et de satisfaction des prothèses ont été amassées à l’aide de questionnaires. Les patients ont aussi subi un examen oral complet lors duquel une évaluation de la stomatite prothétique, basée sur la classification de Newton, a été effectuée ainsi qu’un prélèvement de la plaque prothétique. Les analyses microbiologiques pertinentes afin de détecter la présence de Candida ont ensuite été effectuées. Des tests Chi-carré de Pearson et McNemar ont été utilisés pour analyser la fréquence de la stomatite, son association avec de possibles facteurs de risque ainsi que son évolution dans le temps. Des rapports de cotes (odds ratio) et leurs intervalles de confiance (95%) ont été effectués afin de déterminer la force d’association entre les facteurs de risque et la stomatite prothétique. Résultats : La prévalence de la stomatite a augmenté entre la première (63,6%) et la deuxième année de suivi (88,7%) avec une incidence de 78,8%. Les patients souffrant d’une stomatite de type 2 ou 3 et qui brossent leur palais ont environ 6 fois plus de chance de voir la sévérité de leur stomatite diminuer [p = 0,04 OR 5,88 CI (1,1-32,2)]. Il n’y a pas d’association statistiquement significative entre la fréquence de la stomatite et les facteurs de risque investigués. La prévalence de la candidose est demeurée stable dans le temps (45,8% et 49,2% à la première et deuxième année de suivi respectivement, p > 0,05). Il n’y a pas d’association entre la présence d’une candidose orale, la stomatite prothétique et les facteurs de risque étudiés. Conclusion : Les résultats de cette étude suggèrent que la stomatite prothétique progresse dans le temps indépendamment de la présence d’une candidose. Le brossage du palais pourrait être une approche simple à conseiller aux patients souffrant d’une stomatite prothétique de type 2 ou 3. / Objectives: To assess the evolution of denture stomatitis in term of frequency and severity and its association with potential risk factors over a two-year period. Methods: One hundred thirty five healthy edentulous elders who were randomly rehabilitated with a maxillary complete denture opposed by a conventional denture or an implant-supported overdenture retained by two ball attachments were followed over two years. Demographic and clinical data concerning oral and general health, smoking, denture status and hygienic habits were obtained from oral examination and standard questionnaires. Denture stomatitis was evaluated according to Newton’s classification. Microbiological analyses consist of detection of Candida species in denture plaque and inoculation in selective growth medium. Pearson Chi-square and McNemar tests were used to analyse the frequency of denture stomatitis, its association with potential risk factors and it’s evolution over time. Odds ratios and their 95% confidence intervals were calculated to determine the strength of association between risk factors and denture stomatitis. Results: The prevalence of denture stomatitis increased between the first (63.6%) and second year follow-up (88.7%) with an incidence rate of 78.8%. Those individuals suffering from type 2 or type 3 denture stomatitis and who brushed their palate had approximately 6 times more chance of observing a decrease in the severity of their condition [p=0.04 OR 5.88 CI (1.1-32.2)]. There was no statistically significant association between the frequency of denture stomatitis and classical risk factors at both follow-ups. The carriage rate of Candida species remained stable over time (45.8% and 49.2% first and second year of follow-up consecutively, p > 0.05). There was no association between the presence of oral candidiosis and denture stomatitis or its potential risk factors. Conclusion: The results of this study suggest that denture stomatitis progresses overtime independent of Candida carriage. Palatal brushing could be a preventive approach to minimise the inflammation in individuals suffering from type 2 or type 3 denture stomatitis.

Plusieurs études ont démontré que prés de deux tiers des patients subissant une chirurgie cardiaque souffrent de douleur d’intensité modérée à sévère. Ces niveaux de douleur semblent être partiellement expliqués par la présence de barrières individuelles face au soulagement de la douleur. Le savoir acquis sur les cognitions associées à la douleur ne semble pas avoir été traduit dans de nouvelles approches éducatives face à la douleur aiguë. Le but du projet doctoral était 1) de développer une intervention visant à faciliter l’autogestion de la douleur postopératoire après une chirurgie cardiaque et, 2) d’en évaluer l’acceptabilité et la faisabilité, ainsi que le potentiel d’efficacité sur le soulagement de la douleur de patients subissant une chirurgie cardiaque. Le développement de l’iintervention SOULAGE-TAVIE a inclus quatre étapes fondées sur les savoirs clinique, empirique et théorique et inspirées de plusieurs écrits méthodologiques. SOULAGE-TAVIE consiste en une session préopératoire éducative sur la gestion de la douleur post-chirurgie cardiaque d’approximativement 30 minutes sur un ordinateur, dispensée sur mesure en fonction d’un algorithme. Deux renforcements cliniques en personne sont aussi offerts en phase postopératoire. L’évaluation de l’intervention consistait en un essai clinique pilote à répartition aléatoire incluant 60 participants répartis entre le groupe expérimental (GE : SOULAGE-TAVIE) et le groupe contrôle (GC : soins usuels incluant un feuillet d’information). Les données étaient recueillies au moment de l’admission et dans les sept jours postopératoires. SOULAGE-TAVIE a été jugée comme acceptable et faisable. De plus, les participants du GE n’ont pas expérimenté une douleur de plus faible intensité mais ils ont rapporté significativement moins d’interférence de la douleur avec la toux et la respiration profonde, ont démontré moins de barrières face à la gestion de la douleur et ont consommé plus d’opiacés. Cette étude pilote procure des résultats prometteurs sur les bénéfices potentiels de cette nouvelle approche sur mesure utilisant les technologies de l’information et de la communication (TIC). L’autonomisation des personnes est cruciale et complémentaire pour soutenir le soulagement de la douleur dans le contexte actuel de soins. / Several studies have shown that many patients undergoing a cardiac surgery suffer from moderate to severe pain. These levels of pain may be explained by individual barriers toward pain relief. Knowledge acquired on pain-related cognitions has not been translated into new approaches. The aim of the doctoral project was 1) to develop an intervention to facilitate the self-management of postoperative pain after cardiac surgery and, 2) to assess its the acceptability and feasibility and to investigate its efficacy potential on pain relief in patients undergoing cardiac surgery. The development of SOULAGE-TAVIE included four steps based on clinical, empirical and theoretical knowledge and inspired by diverse methodological considerations. SOULAGE-TAVIE consists in a 30-minute computer-tailored preoperative educational session about postoperative pain management, tailored according to an algorithm. Two short reinforcements are provided in person. The evaluation of SOULAGE-TAVIE consisted in a pilot randomized controlled trial including 60 participants assigned to the experimental group (EG: SOULAGE-TAVIE) and the control group (CG: usual care including educational pamphlet). Data were collected at the time of admission and across Day 1 to 7 after surgery. The results provide preliminary support for the acceptability and feasibility of a tailored and virtual intervention. The results revealed that patients of the EG did not experience less intense pain but they reported significantly less pain interference when breathing/coughing, exhibited fewer pain-related barriers, and consumed more opioid medication. This pilot study provides promising results to support the potential benefits of this new web-tailored approach. Patient empowerment is complementary yet crucial in the current context of care and may contribute to improve pain relief.

Background: Bipolar disorders (BD) are among the most severe mental disorders with first clinical signs and symptoms frequently appearing in adolescence and early adulthood. The long latency in clinical diagnosis (and subsequent adequate treatment) adversely affects the course of disease, effectiveness of interventions and health-related quality of life, and increases the economic burden of BD. Despite uncertainties about risk constellations and symptomatology in the early stages of potentially developing BD, many adolescents and young adults seek help, and most of them suffer substantially from symptoms already leading to impairments in psychosocial functioning in school, training, at work and in their social relationships. We aimed to identify subjects at risk of developing BD and investigate the efficacy and safety of early specific cognitive-behavioural psychotherapy (CBT) in this subpopulation. Methods/Design: EarlyCBT is a randomised controlled multi-centre clinical trial to evaluate the efficacy and safety of early specific CBT, including stress management and problem solving strategies, with elements of mindfulness-based therapy (MBT) versus unstructured group meetings for 14 weeks each and follow-up until week 78. Participants are recruited at seven university hospitals throughout Germany, which provide in- and outpatient care (including early recognition centres) for psychiatric patients. Subjects at high risk must be 15 to 30 years old and meet the combination of specified affective symptomatology, reduction of psychosocial functioning, and family history for (schizo)affective disorders. Primary efficacy endpoints are differences in psychosocial functioning and defined affective symptomatology at 14 weeks between groups. Secondary endpoints include the above mentioned endpoints at 7, 24, 52 and 78 weeks and the change within groups compared to baseline; perception of, reaction to and coping with stress; and conversion to full BD. Discussion: To our knowledge, this is the first study to evaluate early specific CBT in subjects at high risk for BD. Structured diagnostic interviews are used to map the risk status and development of disease. With our study, the level of evidence for the treatment of those young patients will be significantly raised.