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Anxiety/pain is a combined experience that can hinder dental treatment in children and lead to the development of negative behaviours in any form of surgical treatment. Hypnosis is a suitable option with which to reduce anxiety and pain during dental treatment. In this study, we aimed to evaluate the efficacy of hypnosis compared to the tell/show/do technique for the reduction of anxiety and pain as measured by Face, Legs, Activity, Crying, Consolability (FLACC) scale in children undergoing pulpotomies. We performed a randomized and controlled clinical trial involving 60 children aged 5 to 7 years without previous dental experiences but with clinical and radiographic indications for pulpotomy in the primary mandibular right or left first or second molar. The children were divided into two groups: a control group (treated by conventional behaviour management techniques) and an experimental group (treated by hypnosis). The FLACC scale was used to evaluate anxiety/pain during preoperative, transoperative and postoperative pulpotomy treatment; we also analysed variations in heart rate and skin conductance. The trial was registered at ClinicalTrials.gov (NCT03739346). Statistical analysis was performed in R Studio version 1.2.1335. The FLACC scale was significantly lower in the experimental group (p = 0.022) throughout the entire treatment duration. In addition, heart rate and global skin conductance were both significantly lower in the experimental group when measured at different times (p = 0.005 and p = 0.032, respectively). When compared to conventional behavioural management techniques, the FLACC scale demonstrated that hypnosis was associated with significant reductions in heart rate, skin conductance and anxiety/pain throughout the entire duration of treatment. decreases anxiety/pain during the entire operative procedure. There was clear improvements in anxiety and pain control in patients receiving hypnotic therapy.

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OBJECTIVE: To evaluate the effects of activated charcoal-based products used in two presentation forms (powder or toothpaste), compared to 10 % carbamide peroxide and conventional toothpaste on aesthetic perception and psychosocial impact before and after treatment. METHODS: Fifty-six participants were divided into 4 experimental groups (n = 14). Activated charcoal-based powder (PW); Activated charcoal-based dentifrice (AC); Conventional fluoride toothpaste (CD) and 10 % carbamide peroxide (CP). All products were used for 14 days. Psychosocial impact on dental esthetics (PIDAQ), oral health impact profile (OHIP- Esthetics) and orofacial esthetics scale (OES) questionnaires were applied before and after treatment. Descriptive and exploratory data analyses were performed and analyzed using linear mixed models for repeated measures over time considering significance level of α = 0.05. RESULTS: For PIDAQ, the CP group showed significant decrease in psychological impact, aesthetic perception domains and overall score, while in the PW group, there was only a significant decrease in the psychological impact domain. Decrease in OHIP was observed for the functional limitation domain scores for treatments with CP and PW, in the psychological discomfort domain, decrease was observed for all groups, while for the OES questionnaire, significant increase in the color domain was observed for the CP group. CONCLUSION: Activated charcoal-based products showed lower scores in all questionnaires when compared with carbamide peroxide; thus, charcoal-based products promoted lower impact on quality of life and aesthetic perception. CLINICAL RELEVANCE: In this randomized clinical trial, charcoal-based OTC products had inferior quality of life and aesthetic perception results compared to conventional carbamide peroxide bleaching.

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RESUMEN Objetivo: Comparar dos técnicas quirúrgicas para extirpar el pterigión, mediante la evaluación de la sintomatología postoperatoria y la incidencia de la recidiva. Métodos: Ensayo clínico controlado aleatorizado con dos grupos paralelos y diseño simple ciego en 80 pacientes con pterigión primario de la Clínica Oftalmológica de la Selva. El primer grupo consideró la técnica de autoplastia fijada con cauterio bipolar (n=40) y el segundo la técnica convencional de autoplastia fijada con puntos (n=40). Se evaluaron los síntomas a las 72 horas postoperatorias y la recidiva a los seis meses. Resultados: A las 72 horas postcirugía el 6 % de los operados con la técnica electrocauterio presentaron sintomatología en comparación a un 41 % de los operados con sutura (p<0,05). Se evidenció recurrencia de 1 caso en el grupo de electrocauterio y 4 en el grupo de sutura (2,5 % vs. 10 %, p<0,05). Conclusiones: La técnica con cauterio demostró una recuperación más favorable, con menor sintomatología y recurrencia en comparación a la técnica convencional. Estos hallazgos sugieren que la técnica con cauterio puede ser más efectiva y mejor tolerada en pacientes de este estudio.

ABSTRACT Objective: To compare two surgical techniques for excising pterygium, by evaluating postoperative symptoms and the incidence of recurrence. Methods: Randomized controlled clinical trial with two parallel groups and a single-blind design involving eighty patients with primary pterygium from the Ophthalmological Clinic of the Jungle. The first group considered the autograft fixation technique with bipolar cautery (n=40), and the second group considered the conventional autograft fixation technique with sutures (n=40). Symptoms were assessed at 72 hours postoperatively, and recurrence was evaluated at six months. Results: At 72 hours post-surgery, 6% of patients operated with the electrocautery technique exhibited symptoms, compared to 41% of those operated with sutures (p < 0.05). Recurrence was observed in 1 case in the electrocautery group and 4 in the suture group (2.5% vs. 10%, p < 0.05). Conclusions: The cautery technique demonstrated a more favorable recovery, with fewer symptoms and recurrence compared to the conventional technique. These findings suggest that the cautery technique may be more effective and better tolerated in patients in this study.

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Chronic nonspecific low back pain (CNLBP) is the most common musculoskeletal condition, which can be influenced by nociceptive, psychosocial, cognitive, and affective aspects, causing vulnerabilities and impairing the individual's ability to manage pain. The association of continuous shortwave diathermy (CSWD) with Pilates-based exercises may contribute to reduce pain, depression, and anxiety in patients with CNLBP. A single-blind randomized clinical trial was performed in which 36 patients with CNLBP were divided into a control group that received placebo CSWD and an intervention group that received active CSWD. Both groups received 12 sessions of Pilates-based exercises. Pain, depression, and anxiety variables were evaluated using the McGill questionnaire, the Beck Depression Inventory, and the Visual Analog Anxiety Scale. Assessments were performed at baseline, after three and six weeks of treatment, and at the three-month follow-up. The Shapiro-Wilk test, Student's t-test, Mann-Whitney U test, chi-squared test, and repeated measures ANOVA, with α=0.05, were used to compare the outcomes, and indicated that active CSWD did not present additional improvement in the assessed variables in CNLBP patients compared to the placebo group. Both groups improved pain and depression at follow-up and reduced anxiety only during Pilates-based exercises. Therefore, only Pilates-based exercises seemed sufficient to manage patients with CNLBP.

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Introducción: El derrame pleural paraneumónico resulta la complicación más frecuente de la neumonía bacteriana, de manejo complejo y muchas veces quirúrgico. No existen publicaciones en Cuba provenientes de ensayos clínicos controlados y aleatorizados ni del uso de la estreptoquinasa recombinante (Heberkinasa®) en el derrame pleural. Objetivo: Evaluar la eficacia y la seguridad de la Heberkinasa® en el tratamiento del derrame pleural paraneumónico complicado complejo y el empiema en niños. Métodos: Ensayo clínico fase III, abierto, aleatorizado (2:1), en grupos paralelos y controlado. Se concluyó la inclusión prevista de 48 niños (1-18 años de edad), que cumplieron los criterios de selección. Los progenitores otorgaron el consentimiento informado. Los pacientes se distribuyeron en dos grupos: I- experimental: terapia estándar y administración intrapleural diaria de 200 000 UI de Heberkinasa® durante 3-5 días y II-control: tratamiento estándar. Las variables principales: necesidad de cirugía y la estadía hospitalaria. Se evaluaron los eventos adversos. Resultados: Ningún paciente del grupo I-experimental requirió cirugía, a diferencia del grupo II-control en el que 37,5 por ciento necesitó cirugía video-toracoscópica, con diferencia altamente significativa. Se redujo la estadía hospitalaria (en cuatro días), las complicaciones intratorácicas y las infecciones asociadas a la asistencia sanitaria en el grupo que recibió Heberkinasa®. No se presentaron eventos adversos graves atribuibles al producto. Conclusiones: La Heberkinasa® en el derrame pleural paraneumónico complicado complejo y empiema resultó eficaz y segura para la evacuación del foco séptico, con reducción de la necesidad de tratamiento quirúrgico, de la estadía hospitalaria y de las complicaciones, sin eventos adversos relacionados con su administración(AU)

Introduction: Paraneumonic pleural effusion is the most frequent complication of bacterial pneumonia, with complex and often surgical management. There are no publications in Cuba from randomized controlled clinical trials or the use of recombinant streptokinase (Heberkinase®) in pleural effusion. Objective: To evaluate the efficacy and safety of Heberkinase® in the treatment of complex complicated parapneumonic pleural effusion and empyema in children. Methods: Phase III, open-label, randomized (2:1), parallel-group, controlled clinical trial. The planned inclusion of 48 children (1-18 years of age), who met the selection criteria, was completed. Parents gave informed consent. The patients were divided into two groups: I-experimental: standard therapy and daily intrapleural administration of 200,000 IU of Heberkinase® for 3-5 days; and II-control: standard treatment. The main variables: need for surgery and hospital stay. Adverse events were evaluated. Results: No patient in group I-experimental required surgery, unlike group II-control in which 37.5 percent required video-assisted thoracoscopic surgery, with a highly significant difference. Hospital stay (to 4 days), intrathoracic complications and infections associated to healthcare in the group that received Heberkinase® was reduced. No serious adverse events attributable to the product occurred. Conclusions: Heberkinase® in complex complicated parapneumonic pleural effusion and empyema was effective and safe for the draining of the septic focus, with reduction of the need for surgical treatment, hospital stay and complications, with no adverse events related to its administration(AU)

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ABSTRACT Objectives: to evaluate the effect of music applied within ten and 15 minutes, combined with swaddling, on behavioral (facial action) and physiological (heart rate) responses to pain in full-term newborns, before and during venipuncture for blood sampling. Methods: a randomized, triple-blind, clinical trial with 52 rooming in infants randomly assigned to four groups of 13: Experimental 1 (music [ten minutes] plus swaddling), Experimental 2 (music [15 minutes] plus swaddling), Control 1 (no music [ten minutes] plus swaddling), and Control 2 (no music [15 minutes] plus swaddling). Pain was measured using the Neonatal Facial Coding System in the basal and procedural moments. Results: experimental 2 group showed high pain absence (p < 0.05); low heart rate mean (p < 0.0001) in the basal and procedural (antisepsis, puncture, blood squeezing/aspiration, compression) moments. Conclusions: neonates who listened to 15 minutes of music plus swaddling showed a greater absence of facial pain actions.

RESUMEN Objetivos: evaluar el efecto de la música aplicada en 10 y 15 minutos, combinada con swaddling, en la respuesta comportamental al dolor (mímica facial) y fisiológica (frecuencia cardíaca) de los recién nacidos a término, antes y durante la punción venosa para la extracción de sangre. Métodos: ensayo clínico aleatorizado, triple ciego, realizado en alojamiento conjunto con 52 recién nacidos, dividido aleatoriamente en cuatro grupos de 13: Experimental 1 (música [10 minutos], swaddling), Experimental 2 (música [15 minutos], swaddling), Control 1 (sin música [10 minutos, swaddling) y Control 2 (sin música [15 minutos], swaddling,). El dolor se midió utilizando el Neonatal Facial Coding System en los momentos Basal y Procedimiento. Resultados: el grupo experimental 2 mostró alta ausencia de dolor (p <0.05); media de frecuencia cardíaca baja (p<0,0001) en los momentos Basal y Procedimiento (antisepsia, punción, ordeño/aspiración de sangre, compresión). Conclusiones: recién nacidos que escucharon 15 minutos de música más swaddling mostraron una mayor ausencia de reacciones faciales de dolor.

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Objetivo:avaliar taxa de cicatrização em úlceras do pé diabético tratadas com biomembrana de proteínas do látex de Calotropis procera (BioMem CpLP) quando comparada ao hidrocoloide em pó. Método: ensaio clínico randomizado controlado, registrado pelo Registro Brasileiro de Ensaio Clínico (REBEC), conforme protocolo RBR-98f3j9, realizado junto a oito pessoas com pé diabético, em ambulatório de pé diabético, de março a julho de 2019. No grupo experimental (n=04), realizou-se a aplicação de biomembrana; no grupo controle (n=04), utilizou-se o pó de hidrocoloide. A taxa de cicatrização foi avaliada com 30 e 60 dias após início do tratamento. Resultados: não se constataram diferenças estatísticas entre taxas de cicatrização do grupo controle e do grupo experimental na análise temporal dos 30 dias iniciais (p=0,726) e nos 60 dias subsequentes ao início do tratamento (p=0,562). Conclusão: a BioMem CpLP apresentou taxas de cicatrização semelhantes ao produto convencional, configurando-se como alternativa eficaz e de baixo custo para o tratamento de pés diabéticos.

Objective:to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.

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BACKGROUND: The absence of specific antivirals to treat COVID-19 leads to the repositioning of candidates' drugs. Nitazoxanide (NTZ) has a broad antiviral effect. METHODS: This was a randomized, double-blind pilot clinical trial comparing NTZ 600 mg BID versus Placebo for seven days among 50 individuals (25 each arm) with SARS-COV-2 RT-PCR+ (PCR) that were hospitalized with mild respiratory insufficiency from May 20th, 2020, to September 21st, 2020 (ClinicalTrials.gov NCT04348409). Clinical and virologic endpoints and inflammatory biomarkers were evaluated. A five-point scale for disease severity (SSD) was used. FINDINGS: Two patients died in the NTZ arm compared to 6 in the placebo arm (p = 0.564). NTZ was superior to placebo when considering SSD (p < 0001), the mean time for hospital discharge (6.6 vs. 14 days, p = 0.021), and negative PCR at day 21 (p = 0.035), whereas the placebo group presented more adverse events (p = 0.04). Among adverse events likely related to the study drug, 14 were detected in the NTZ group and 22 in placebo (p = 0.24). Among the 30 adverse events unlikely related, 21 occurred in the placebo group (p = 0.04). A decrease from baseline was higher in the NTZ group for d-Dimer (p = 0.001), US-RCP (p < 0.002), TNF (p < 0.038), IL-6 (p < 0.001), IL-8 (p = 0.014), HLA DR. on CD4+ T lymphocytes (p < 0.05), CD38 in CD4+ and CD8+ T (both p < 0.05), and CD38 and HLA-DR. on CD4+ (p < 0.01). INTERPRETATION: Compared to placebo in clinical and virologic outcomes and improvement of inflammatory outcomes, the superiority of NTZ warrants further investigation of this drug for moderate COVID-19 in larger clinical trials. A higher incidence of adverse events in the placebo arm might be attributed to COVID-19 related symptoms.

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La importancia de la investigación científica referida a la definición de la anemia por deficiencia de hierro en altitud, se relaciona con los hallazgos de los estudios realizados y que permiten avanzar al conocimiento científico, en poblaciones vulnerables, siendo que están dirigidos a mejorar la salud pública e influir en políticas de salud. Se presenta el análisis y reflexión de una innovadora modalidad para nuestro medio de altitud, basada en la suplementación con hierro y folatos para definir anemia en la población estudiada, situación que difiere de investigaciones previas sobre el tema en nuestro contexto de altitud. Estos estudios han tenido un escrutinio intenso de parte de los revisores que han valorado las publicaciones sobre anemia ferropénica a gran altitud. La claridad de los diseños de ensayos clínicos formales y controlados aleatorizados, pertinentes en tiempo y necesarios por su importancia fueron realizados, en regiones de altitud de Bolivia. La falta de reconocimiento por terceros de este nivel de evidencia logrado, equivaldría a sustituirlos por estudios de ensayos no formales y no controlados, es decir seguir aplicando diseños de tipo observacional, con contrastación teórica y lógica que solo incrementan el estado de incertidumbre sobre el tema en Bolivia. El sumario presentado de la historia sobre la anemia ferropénica en regiones de altitud en Bolivia nos permite reflexiones importantes, a saber: 1. Es importante resaltar, como claro ejemplo, que la observación simple puede llevar a la incertidumbre y lo costoso de sus consecuencias futuras por la persistencia de la anemia ferropénica en poblaciones de altitud, más aún si se mantiene el posible manejo de prueba y error en resultados difundidos. 2. Se demuestra la necesidad de los controles en la investigación científica, y finalmente 3. Los ensayos clínicos controlados aleatorizados son la mejor fuente de evidencia confiable.

The importance of scientific research related to the definition of iron deficiency anemia at altitude is related to the findings of the studies carried out and that allow advancing scientific knowledge, in vulnerable populations, being that they are aimed at improving public health and influence health policies. The analysis and reflection of an innovative modality for our altitude environment is presented, based on supplementation with iron and folates to define anemia in the studied population, a situation that differs from previous research on the subject in our altitude context. These studies have received intense scrutiny from reviewers who have evaluated the publications on high altitude iron deficiency anemia. The clarity of the designs of formal and randomized controlled clinical trials, pertinent in time and necessary due to their importance, were carried out in highland regions of Bolivia. The lack of recognition by third parties of this level of evidence achieved, would be equivalent to replacing them with studies of non-formal and uncontrolled trials, that is, to continue applying observational designs, with theoretical and logical contrast that only increase the state of uncertainty on the subject in Bolivia. The summary presented of the history of iron deficiency anemia in high-altitude regions of Bolivia allows us important reflections, namely: 1. It is important to highlight, as a clear example, that simple observation can lead to uncertainty and the cost of its future consequences due to the persistence of iron deficiency anemia in high altitude populations, even more so if the possible trial and error management is maintained in disseminated results. 2. The need for controls in scientific research is demonstrated, and finally 3. Randomized controlled clinical trials are the best source of reliable evidence.

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Background: COVID-19 has taken many lives worldwide and due to this, millions of persons are in grief. When the grief process lasts longer than 6 months, the person is in risk of developing Complicated Grief Disorder (CGD). The CGD is related to serious health consequences. To reduce the probability of developing CGD a preventive intervention could be applied. In developing countries like Mexico, the psychological services are scarce, self-applied interventions could provide support to solve this problem and reduce the health impact even after the pandemic has already finished. Aims: To design and implement a self-applied intervention composed of 12 modules focused on the decrease of the risk of developing CGD, and increasing the life quality, and as a secondary objective to reduce the symptomatology of anxiety, depression, and increase of sleep quality. The Intervention Duelo COVID (Grief COVID) follows the principles of User Experience (UX) and is designed according to the needs and desires of a sample of the objective participants, to increase the adherence to the self-applied intervention, considered one of the main weaknesses of online interventions. Methods: A Randomized Controlled Trial will be conducted from the 22nd of December of 2020 to the first of June 2021. The participants will be assigned to an intervention with elements of Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Mindfulness and Positive Psychology. The control group will be a wait-list condition, that will receive the intervention 1.5-2 months after the pre-measurement were taken. The Power Size Calculation conducted through G*Power indicated the need for a total of 42 participants, which will be divided by 21 participants in each group. The platform will be delivered through responsive design assuring with this that the intervention will adapt to the screen size of cellphones, tablets, and computers. Ethics and Dissemination: The study counts with the approval of the Research Ethics Committee of the Autonomous University of Ciudad Juárez, México, and it is registered in Clinical Trials (NCT04638842). The article is sent and registered in clinical trials before the recruitment started. The results will be reported in future conferences, scientific publications, and media.

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INTRODUCTION: Mixed-specifier mood disorders are probably a different subgroup in terms of response to treatment, socio-demographic parameters, course, and family history. Here we describe the rationale and design of a clinical trial aimed to test the efficacy, safety, and tolerability of a non-pharmacological treatment known as theta-burst stimulation (TBS) for treating the mixed depressive episodes of both bipolar (I or II), and unipolar depression. METHODS: The study is designed as a randomized, sham-controlled, double-blinded clinical trial evaluating TBS for the treatment of moderate or severe major depressive episodes with mixed features of patients receiving at least one first or second-line pharmacological treatment for depressive episodes without adequate response. Ninety adult (18 to 65 years old) patients will be enrolled and submitted to 6-week (comprising 5 consecutive days a week sessions for the first 3 weeks and then 2 days a week for a further 3 week) of inhibitory followed by excitatory TBS in dorsolateral prefrontal cortex. Participants will be assessed using clinical and neuropsychological tests before and after the intervention. The primary outcome is change in Montgomery-Åsberg Depression Scale (MADRS) score over time and across groups. Cognitive parameters will also be assessed with neuropsychological tests. RESULTS: The clinical results will provide evidence about TBS as an adjunctive treatment for mixed depression treatment and neuropsychological parameters will contribute toward an improved understanding the effects of TBS in cognition. CONCLUSION: Our results could introduce a novel therapeutic technique for mixed depressive episodes of both bipolar and unipolar disorders. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov, identifier NCT04123301; date of registration: 10/10/2019; URL: https://clinicaltrials.gov/ct2/show/NCT04123301?term=NCT04123301&rank=1.

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Resumo: Objetivou-se avaliar o efeito de um Guia Autoinstrucional para Raciocínio Clínico na acurácia diagnóstica de estudantes de bacharelado em enfermagem durante a resolução de estudos de caso. Realizou-se ensaio clínico randomizado paralelo e cego, com duas fases, e grupo intervenção (que utilizou o guia) e controle (sem utilizar o guia). A coleta de dados ocorreu de fevereiro a junho de 2019 com estudantes de quatro turmas de dois cursos graduação em Enfermagem no Paraná. Foram incluídos acadêmicos regularmente matriculados, presentes na primeira fase da aplicação e que cursaram, com aprovação, as disciplinas de Fundamentos do Cuidado de Enfermagem e Enfermagem em Saúde do Adulto e do Idoso e correspondentes. Foram excluídos acadêmicos com diagnóstico médico de dislexia e que não completaram a resolução do estudo de caso na segunda fase. Utilizou-se dois estudos de caso validados e que simularam paciente com dificuldade respiratória. A atividade requeria que o estudante identificasse um diagnóstico/problema de enfermagem prioritário do paciente, a etiologia (causa) desse problema e as pistas (sinais e sintomas) que justificavam esse problema. Para avaliar a acurácia das respostas utilizou-se rubricas validadas e baseadas na Escala de Acurácia Diagnóstica de Lunney, sendo realizado consenso, pós avaliação, por duas pesquisadoras. Foi utilizada estatística descritiva para os dados demográficos; teste exato de Fisher para determinar similaridades na educação prévia, sexo e confiança do estudante quanto ao conhecimento e seu uso; teste de Mann-Whitney para análise da idade; teste Anova não paramétrico para medidas repetidas na avaliação da hipótese de existir diferença na evolução da pontuação dos estudantes, ao longo de tempo, nos dois grupos. Valores de p<0,05 foram considerados significativos. A amostra final foi composta por 51 estudantes, 24 alocados no grupo controle e 27 no grupo intervenção; 82,4% (n=42) do sexo feminino e 98% (n=50) cursando a primeira graduação; com média de idade de 22 anos e sem diferença entre os grupos. Foi identificado diminuição dos escores, com diferença estatística, entre primeira e segunda fase para acurácia diagnóstica (p=0,041) e para acurácia etiológica (p=0,0351) no grupo intervenção na fase 2. Houve redução na identificação de pistas relevante nos dois grupos, porém sem diferença estatística. Observou-se efeito negativo na utilização do Guia; infere-se que a aplicação única e não explicação prévia pode ter influenciado os resultados. Considerando o potencial do Guia no desenvolvimento do raciocínio clínico e acurácia diagnóstica de estudantes sugere-se sua aplicação, como ferramenta didática, ao longo do semestre, com explicação prévia do professor, com vistas a favorecer a qualidade na assistência e segurança do paciente

Abstract: This study aimed to evaluate the effect of a Self-instructional Guide for Clinical Reasoning on the diagnostic accuracy of baccalaureate nursing students during case study solving. A blind and parallel randomized clinical trial was performed, with two phases, and intervention (using the guide) and control (without using the guide) group. Data collection took place from February to June 2019 with students from four classes of two undergraduate Nursing courses in the State of Paraná, Brazil. Those who were regularly enrolled, present in the first phase of the application and attended, with approval, the subjects of Fundamentals of Nursing Care and Adult and Elderly Health and their correspondents were included; Those with a medical diagnosis of dyslexia or who did not complete the resolution of the second phase case study were excluded. Two validated case studies were used, which simulated patients with difficulty breathing. The activity required the student to identify a patient's priority nursing diagnosis/patient problem, the etiology of this problem and the clues (signs and symptoms) that justified this problem. To assess the accuracy of the answers, validated rubrics were used, based on the Lunney Diagnostic Accuracy Scale, with consensus, after evaluation, by two researchers. Descriptive statistics were used for demographic data; Fisher's exact test to determine similarities in prior education, gender, and student confidence in knowledge and use; Mann-Whitney test for age analysis; Nonparametric Anova test for repeated measures in the evaluation of the hypothesis that there is a difference in the evolution of students' scores over time in both groups. P values <0.05 were considered significant. The final sample consisted of 51 students, 24 in the control group and 27 in the intervention group; 82.4% (n = 42) female and 98% (n = 50) attending the first graduation; with an average age of 22 years and with no difference between groups. Decreased scores were identified, with statistical difference between phase 1 and 2 for diagnostic accuracy (p=0.041) and for etiological accuracy (p=0.0351) in the phase 2 intervention group. There was a reduction in the identification of relevant clues in both groups, however without statistical difference. There was a negative effect on the use of the Guide; It can be inferred that a single application without a previous explanation may have influenced the results. Considering the potential of the Guide in the development of clinical reasoning and diagnostic accuracy of students, its application is suggested as a didactic tool throughout the semester, with a prior explanation of the teacher, to favor quality care and patient safety.

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OBJECTIVES: This randomized triple-blind clinical trial, split-mouth design, evaluated the application effect of the desensitizing gel before and after in-office bleaching on tooth sensitivity. MATERIALS AND METHODS: In one group, the desensitizing gel was applied for 10 min before the bleaching with 35% hydrogen peroxide, and then application of placebo gel after (n = 90). In the other group, the desensitizing gel was applied before and after the bleaching procedure for 10 min (n = 90). The primary outcome was pain intensity assessed with a numeric rating scale and a visual analog scale. Color was evaluated by means of a digital spectrophotometer and a shade guides. RESULTS: The proportion of patients that experienced pain in the side of before application was 90% (95% CI 82 to 94.6%), while the side of before and after was 93% (95% CI 86.2 to 96.9%), without significant difference between groups (OR = 0.25; 95% CI 0.005 to 2.52; p = 0.37). Pain was correlated in both groups, for the NRS scale (p < 0.0001) and the VAS scale (p < 0.0001) in all assessment periods. Significant whitening was detected, and no significant difference of color change was observed between groups (p > 0.45). CONCLUSIONS: The application of the desensitizing agent did not influence the effectiveness of bleaching, but it was not efficient in reducing the sensitivity, when applied before the procedure, or before and after. CLINICAL RELEVANCE: The use of a desensitizing gel before or after in-office bleaching does not reduce incidence or intensity of tooth sensitivity.

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ABSTRACT Objectives: To compare the knowledge on surgical safety through the team-based learning methodology and lecture classes for undergraduate Nursing students, and evaluate the learning satisfaction with team-based learning. Methods: Randomized, controlled, parallel, two-arm, unblinded clinical trial developed in the Faculty of Medicine of a public university in Botucatu, Brazil. The groups included 14 students for team-based learning and 11 students for lecture classes. Results: Students' apprehension of knowledge in the team-based learning group was significantly higher compared to the control group (p<0.002) by considering the pre-test results. After 30 days, there was no significant difference between groups. The experience with the methodology was considered positive among students. Conclusions: Team-based learning is an important pedagogic tool available and has proven effective in education and learning with students playing the role of protagonists.

RESUMEN Objetivos: Comparar la aprehensión del conocimiento en seguridad quirúrgica por la metodología del aprendizaje basada en equipos y clase expositiva para alumnos de graduación en enfermería y evaluar la satisfacción del aprendizaje en el aprendizaje basado en equipos. Métodos: Ensayo clínico aleatorizado, controlado, paralelo, con dos brazos, no ciego, desarrollado en una universidad pública ubicada en Botucatu, Brasil. Los grupos fueron compuestos por 14 alumnos para el aprendizaje basado en equipos y 11 alumnos para clase expositiva. Resultados: La aprehensión del conocimiento de los alumnos del grupo aprendizaje basado en equipos fue significativamente mayor comparado al grupo control (p <0,002) considerados los resultados del pre-test. Después de los 30 días, no hubo diferencia significativa entre los grupos. La experiencia con la metodología fue considerada positiva entre los alumnos. Conclusiones: El aprendizaje basado en equipos es una importante herramienta pedagógica disponible y se muestra eficaz en el proceso de enseñanza-aprendizaje teniendo al alumno como su protagonista.

RESUMO Objetivos: Comparar a apreensão do conhecimento em segurança cirúrgica pela metodologia da aprendizagem baseada em equipes e aula expositiva dialogada para alunos de graduação em enfermagem e avaliar a satisfação do aprendizado na aprendizagem baseada em equipes. Métodos: Ensaio clínico randomizado, controlado, paralelo, com dois braços, sem cegamento, desenvolvido em uma universidade pública paulista. Os grupos foram compostos por 14 alunos para aprendizagem baseada em equipes e 11 alunos para aula expositiva dialogada. Resultados: A apreensão de conhecimento dos alunos do grupo aprendizagem baseada em equipes foi significativamente maior em comparação com o grupo controle (p<0,002) considerados os resultados do pré-teste. Após os 30 dias, não houve diferença significativa entre os grupos. A experiência com a metodologia foi considerada positiva entre os alunos. Conclusões: A aprendizagem baseada em equipes é uma importante ferramenta pedagógica disponível e mostra-se eficaz no processo de ensino-aprendizagem tendo o aluno como seu protagonista.

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ABSTRACT Objectives: To compare the knowledge on surgical safety through the team-based learning methodology and lecture classes for undergraduate Nursing students, and evaluate the learning satisfaction with team-based learning. Methods: Randomized, controlled, parallel, two-arm, unblinded clinical trial developed in the Faculty of Medicine of a public university in Botucatu, Brazil. The groups included 14 students for team-based learning and 11 students for lecture classes. Results: Students' apprehension of knowledge in the team-based learning group was significantly higher compared to the control group (p<0.002) by considering the pre-test results. After 30 days, there was no significant difference between groups. The experience with the methodology was considered positive among students. Conclusions: Team-based learning is an important pedagogic tool available and has proven effective in education and learning with students playing the role of protagonists.

RESUMEN Objetivos: Comparar la aprehensión del conocimiento en seguridad quirúrgica por la metodología del aprendizaje basada en equipos y clase expositiva para alumnos de graduación en enfermería y evaluar la satisfacción del aprendizaje en el aprendizaje basado en equipos. Métodos: Ensayo clínico aleatorizado, controlado, paralelo, con dos brazos, no ciego, desarrollado en una universidad pública ubicada en Botucatu, Brasil. Los grupos fueron compuestos por 14 alumnos para el aprendizaje basado en equipos y 11 alumnos para clase expositiva. Resultados: La aprehensión del conocimiento de los alumnos del grupo aprendizaje basado en equipos fue significativamente mayor comparado al grupo control (p <0,002) considerados los resultados del pre-test. Después de los 30 días, no hubo diferencia significativa entre los grupos. La experiencia con la metodología fue considerada positiva entre los alumnos. Conclusiones: El aprendizaje basado en equipos es una importante herramienta pedagógica disponible y se muestra eficaz en el proceso de enseñanza-aprendizaje teniendo al alumno como su protagonista.

RESUMO Objetivos: Comparar a apreensão do conhecimento em segurança cirúrgica pela metodologia da aprendizagem baseada em equipes e aula expositiva dialogada para alunos de graduação em enfermagem e avaliar a satisfação do aprendizado na aprendizagem baseada em equipes. Métodos: Ensaio clínico randomizado, controlado, paralelo, com dois braços, sem cegamento, desenvolvido em uma universidade pública paulista. Os grupos foram compostos por 14 alunos para aprendizagem baseada em equipes e 11 alunos para aula expositiva dialogada. Resultados: A apreensão de conhecimento dos alunos do grupo aprendizagem baseada em equipes foi significativamente maior em comparação com o grupo controle (p<0,002) considerados os resultados do pré-teste. Após os 30 dias, não houve diferença significativa entre os grupos. A experiência com a metodologia foi considerada positiva entre os alunos. Conclusões: A aprendizagem baseada em equipes é uma importante ferramenta pedagógica disponível e mostra-se eficaz no processo de ensino-aprendizagem tendo o aluno como seu protagonista.

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BACKGROUND: Biological responses to different loading protocols during the bone healing phase in subjects with long time since edentulism, rehabilitated with narrow diameter implants (NDIs) to retain mandibular overdentures (MOs), are still unavailable. OBJECTIVE: This randomized clinical trial compared the peri-implant health, implant stability, and concentrations of pro- and anti-inflammatory cytokines in the peri-implant crevicular fluid (PICF) in mandibular edentulous patients under conventional (CL) and immediate loading (IML) during healing. METHODOLOGY: Twenty totally edentulous patients received two NDIs (2.9 × 10 mm, Facility NeoPoros) placed in mandible anterior region and were randomly assigned to two loading protocols: CL (n = 10) and IML (n = 10). The following clinical outcomes were evaluated 1, 2, 4, 8, and 12 weeks after surgery: (a) peri-implant tissue health (gingival index-GI, plaque index-PI, calculus-presence CP, probing depth-PD, and bleeding on probing-BOP); (b) implant stability quotient (ISQ); and (c) IL-1ß, IL-6, IL-10, and TNF-α levels in the PICF analyzed by ELISA. RESULTS: The CL group showed significantly higher CP scores at weeks 8 and 12. The IML group showed significantly higher GI from the first week onwards. The IML group presented significantly lower PD at all follow-up times, and higher BOP rates than CL at week 12. The ISQ values of the CL group were higher than those of the IML group, except at week 4. The IML group released significantly more TNF-α between weeks 1 and 4 and more IL-1ß during week 4-12, while releasing less IL-6 until week 8, mainly at week 2 (-47.6%). The release of IL-10 was similar for both groups and increased progressively over time. At week 12, the IML group released 45.74% more IL-10 than the CL group. The survival rates were 95% and 90% for CL and IML, respectively. CONCLUSION: The IML group presented more favorable PD at all evaluation times; the differences between the other clinical parameters were less systematic. The implant stability and the inflammatory marker concentrations were more stable in the CL group.

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ABSTRACT Objective: To evaluate and compare the perception of stressors by nursing students before and after a high-fidelity clinical simulation or conventional laboratory practice class. Method: This is a randomized clinical trial conducted with 52 nursing students. Both groups had theoretical classes about cardiothoracic physical examination, followed by practice class in skill laboratory. In addition, the experimental group took part in a high-fidelity simulation scenario. Stressors were evaluated before and after class, with the application of KEZKAK questionnaire. Results: The experimental group was significantly more worried about six factors related to lack of competence and to interpersonal relationships (p < 0.05), while the control group was significantly more worried about being in contact with suffering (p = 0.0315). Conclusion: The simulation affects students' perception of stressors and promotes their self-evaluation and critical thinking regarding the responsibility that comes with their learning.

RESUMEN Objetivo: Evaluar y comparar la percepción de los factores de tensión del estudiante de enfermería antes y después de la simulación clínica de la alta fidelidad o de la clase práctica convencional de laboratorio. Método: Ensayo clínico aleatorizado realizado con 52 estudiantes de enfermería. Ambos grupos tuvieron clase teórica sobre el análisis físico cardiotorácico, después de la clase práctica en laboratorio de habilidades. El grupo experimental participó todavía de un escenario de simulación de alta fidelidad. Los factores de tensión fueron evaluados antes y después de la clase, con la aplicación del cuestionario KEZKAK. Resultados: El grupo experimental se presentó significativamente más preocupado con seis factores relacionados a la falta de competencia y relación interpersonal (p < 0,05), mientras que en el grupo control solamente el factor contacto con el sufrimiento fue significativamente más relevante (p= 0,0315). Conclusión: La simulación interfiere en la percepción de los factores de tensión y promociona una autoevaluación y el reflejo crítico por el alumno delante de la responsabilidad con el aprendizaje.

RESUMO Objetivo: Avaliar e comparar a percepção dos fatores estressores do discente de enfermagem antes e depois da simulação clínica de alta fidelidade ou da aula prática convencional de laboratório. Método: Ensaio clínico randomizado realizado com 52 discentes de enfermagem. Ambos os grupos tiveram aula teórica sobre exame físico cardiotorácico, seguida de aula prática em laboratório de habilidades. O grupo experimental participou ainda de um cenário de simulação de alta fidelidade. Os fatores estressores foram avaliados antes e após a aula, com a aplicação do questionário KEZKAK. Resultados: O grupo experimental apresentou-se significativamente mais preocupado com seis fatores relacionados à falta de competência e relação interpessoal (p < 0,05), enquanto no grupo controle apenas o fator contato com o sofrimento foi significativamente mais relevante (p= 0,0315). Conclusão: A simulação interfere na percepção dos fatores estressores e promove uma autoavaliação e reflexão crítica pelo aluno frente à responsabilidade com o aprendizado.

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Resumo: O cateter de Hickman® é um cateter venoso central de longa permanência semi-implantado e tem sido utilizado na realização do transplante de células-tronco hematopoéticas por tolerar infusão parenteral intensa, comumente utilizada nesta modalidade terapêutica. Apesar dos seus benefícios, sua utilização não está isenta de complicações, incluindo a oclusão, caracterizada pela impossibilidade de infundir solução em seu lúmen, incapacidade de aspirar sangue do mesmo ou ambos. Manter a permeabilidade de um cateter venoso central é um desafio, pois depende da lavagem e bloqueio com técnicas adequadas. Além disso, há pouca evidência científica para determinar a melhor solução para o bloqueio do cateter. Objetivo: Avaliar a efetividade da solução de heparina 50 UI/mL comparada à solução salina isotônica 0,9%na prevenção de oclusão do Cateter de Hickman® em pacientes submetidos a transplante de células-tronco hematopoéticas. Método: Ensaio clínico randomizado triplo cego, realizado no serviço de transplante de medula óssea de um hospital público de ensino, no período de março a setembro/2017. Participaram pacientes submetidos a transplante de células-tronco hematopoéticas, os quais foram alocados aleatoriamente no grupo heparina (n=7) e no grupo solução salina isotônica 0,9% (n=10) para bloqueio do cateter. Resultados: Foram avaliados 17 cateteres duplo lúmen, em que as duas vias do cateter foram analisadas separadamente, totalizando 34 lumens. O grupo heparina foi composto de sete cateteres (41,17%) e o grupo solução salina isotônica 0,9%, de dez cateteres (58,83%). A média de dias até o desfecho oclusão foi de 52 no grupo heparina e 13,46 no grupo solução salina isotônica 0,9% na via branca do cateter (p<0,001). Na via vermelha, a média de dias de acompanhamento do grupo heparina foi de 35,29, sem ocorrência de oclusão e, de 22,30 no grupo solução salina isotônica 0,9% até a primeira oclusão (p=0,030). Uma análise secundária realizada de acordo com a via avaliou que a via branca teve 14,28% de oclusão (n=1) no grupo heparina, caracterizada como oclusão completa e 90% de oclusões (n=9) no grupo solução salina isotônica 0,9%, sendo três oclusões completas (30%) e seis oclusões sem refluxo (60%), mostrando diferença significativa entre os grupos (p=0,006). A via vermelha não apresentou oclusão no grupo heparina, já no grupo solução salina isotônica 0,9% ocorreram cinco oclusões (50%), sendo uma oclusão completa (10%) e quatro oclusões sem refluxo (40%) (p=0,084). Conclusões: Houve diferença significativa em relação ao número de dias até o desfecho oclusão da via branca do cateter, utilizando a solução de heparina 50UI/mL em relação à solução salina isotônica 0,9%(p<0,001). E, na via vermelha, apresentou cinco oclusões no grupo solução salina isotônica 0,9%, em uma amostra de dez cateteres versus nenhuma oclusão no grupo heparina. Os resultados da pesquisa evidenciaram que o bloqueio com solução de heparina 50 UI/mL é mais efetivo em relação à solução salina isotônica 0,9%, na prevenção da oclusão do CVCLP-SI de Hickman®.

Abstract: Hickman® catheter is a long-term, semi-implantable central venous catheter used to perform hematopoietic stem-cell transplantation as it takes large infusion volume of parenteral nutrition, commonly used for that therapeutics. Despite its benefits, its use holds some complications, including occlusion, characterized by the infusion blockage into its lumen, incapability to aspirate blood or both hindrances. Keeping the permeability of a central venous catheter is challenging, once it depends on proper techniques for flushing and locking. Moreover, there is scarce scientific evidence to determine the best solution to catheter obstruction. Objective: To assess the effectiveness of 50 IU/mL heparin flush compared to 0.9% isotonic saline solution in order to prevent the occlusion of the Hickman® catheter in patients undergoing hematopoietic stem-cell transplantation. Method: Triple-blinded randomized clinical trial, carried out in the bone-marrow transplantation service of a public teaching hospital between March and September/2017. The participants were patients undergoing hematopoietic stem-cell transplantation, randomly placed in the heparin flush group (n=7), and in the 0.9% isotonic saline solution group (n=10) for catheter patency. Results: 17 double-lumen catheters were assessed, with their two tubes being separately analyzed, totaling 34 lumens. The heparin flush group comprised seven catheters (41.17%), and the 0.9% isotonic saline solution group entailed ten catheters (58.83%). Mean catheter duration until occlusion was 52 days in the heparin group, and 13.46 days in the 0.9% isotonic saline solution group for the white lumen of the catheter (p<0.001), and 35.29 days in the heparin flush group, and 22.30 days in the 0.9% isotonic saline solution group without occlusion for the red lumen of the catheter (p=0.030). A secondary lumen analysis evidenced that the white lumen had 14.28% of occlusions (n=1) in the heparin flush group, featuring complete occlusion, and 90% of occlusions (n=9) in the 0.9% isotonic saline solution group, featuring three complete occlusions (30%), and six occlusions without reflux (60%), showing significant difference between the groups (p=0.006). The red lumen of the catheter did not evidence any occlusions in the heparin flush group, while in the 0.9% isotonic saline solution group, five occlusions occurred, that is, a complete occlusion (10%), and four occlusions without reflux (40%) (p=0.084). Conclusions: There was significant difference regarding the days of catheter duration until occlusion for the white lumen of the catheter, which used 50 IU/mL heparin flush, comparing to the use of 0.9% isotonic saline solution (p<0.001). As for the red lumen, it featured five occlusions in the 0.9% isotonic saline solution group for a sample of ten catheters versus no occlusions in the heparin flush group.The results in this research study evidenced that 50 IU/mL heparin flush patency is more effective than 0.9% isotonic saline solution in order to prevent the obstruction of the Hickman®'s long-term, semi-implantable central venous catheter.

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ABSTRACT Objective: To evaluate the effects of Dramatic Therapeutic Play (DTP) technique on the degree of anxiety in hospitalized school-age children. Method: Randomized clinical trial performed in two hospitals ofSão Paulo, between May and October 2015. The intervention consisted of the application of DTP and the outcome was evaluated through the Child Drawing: Hospital (CD: H) instrument. The Wilcoxon-Mann Whitney, Corrected t, Fisher's exact and Chi-square tests were used in the analysis. Statistical significance was set at 5%. Results: In all, 28 children participated in the study. The majority of children (75%) had a low anxiety score, with a mean CD: H score of 73.9 and 69.4 in the intervention and control groups respectively, and with no significant difference. Conclusion: Children submitted to DTP had the same degree of anxiety as those in the control group. However, it is suggested that new studies be performed with a larger number of children in different hospitalization scenarios.

RESUMEN Objetivo: Evaluar los efectos de la aplicación de la técnica del Juguete Terapéutico Dramático (BTD) en el grado de ansiedad en niños en edad escolar hospitalizados. Método: Ensayo clínico aleatorizado realizado en dos hospitales de São Paulo, entre mayo y octubre de 2015. La intervención consistió en la aplicación del BTD y el resultado fue evaluado por medio del instrumento Child Drawing: Hospital (CD:H). Se utilizó en el análisis los testesWilcoxon-Mann Whitney, T corregido, Exacto de Fisher y Qui-cuadrado con significancia de 5%. Resultados: Participaron del estudio 28 niños. La mayoría de los niños de ambos los grupos (75%) presentó clasificación de bajo grado de ansiedad, siendo la puntuación media del instrumento CD:H en el grupo intervención de 73,9 y en el grupo control de 69,4, sin diferencia significativa. Conclusión: Los niños sometidos al BTD presentaron el mismo grado de ansiedad que los del grupo control. Sin embargo, se sugiere que nuevos estudios sean realizados con mayor número de niños en variados escenarios de la hospitalización.

RESUMO Objetivo: Avaliar os efeitos da aplicação da técnica do Brinquedo Terapêutico Dramático (BTD) no grau de ansiedade em crianças escolares hospitalizadas. Método: Ensaio clínico randomizado realizado em dois hospitais de São Paulo, entre maio e outubro de 2015. A intervenção consistiu na aplicação do BTD e o desfecho foi avaliado por meio do instrumento Child Drawing: Hospital (CD:H). Utilizaram-se na análise os testes Wilcoxon-Mann Whitney, T corrigido, Exato de Fisher e Qui-quadrado com significância de 5%. Resultados: Participaram do estudo 28 crianças. A maioria das crianças de ambos os grupos (75%) apresentou classificação de baixo grau de ansiedade, sendo o escore médio do instrumento CD: H no grupo intervenção de 73,9 e no grupo controle de 69,4, sem diferença significativa. Conclusão: As crianças submetidas ao BTD apresentaram o mesmo grau de ansiedade que as do grupo controle. Entretanto, sugere-se que novos estudos sejam realizados com maior número de crianças em variados cenários da hospitalização.

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