Effect of music combined with swaddling on pain in full-term newborns: randomized clinical trial / Efecto de la música combinada com swaddling en el dolor en recién nacidos a término: ensayo clínico aleatorizado

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.

Taxa de cicatrização em úlceras do pé diabético tratadas com biomembrana e hidrocoloide em pó: ensaio clínico randomizado / Healing rate in diabetic foot ulcers treated with biomembrane and hydrocolloid powder: randomized clinical trial / Tasa de curación en la úlceras de pie diabético tratados con biomembrana e hidrocoloide en polvo: ensayo clínico aleatorizado

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.

Team-Based Learning: a randomized clinical trial in undergraduate nursing / Aprendizaje Basado en Equipos: un ensayo clínico randomizado en la graduación en enfermería / Aprendizagem baseada em equipes: um ensaio clínico randomizado na graduação em enfermagem

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.

Team-Based Learning: a randomized clinical trial in undergraduate nursing / Aprendizaje Basado en Equipos: un ensayo clínico randomizado en la graduación en enfermería / Aprendizagem baseada em equipes: um ensaio clínico randomizado na graduação em enfermagem

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.

[Spanish adaptation of the free OxMaR software for minimization and randomization of clinical studies]. / Versión en español del software gratuito OxMaR para minimización y aleatorización de estudios clínicos.

Randomized clinical trials provide the highest level of scientific evidence. The method used for randomization should make the group to which each case will be assigned unpredictable and facilitate the concealment of the randomization sequence. Centralized methods, generally implemented with computer support, are considered the safest to avoid biases. The OxMaR system, acronym for Oxford Minimization and Randomization, was published as free and open source software in 2014. It works online in a web environment and allows simple randomization and adaptive assignment through minimization. We present a Spanish version developed in collaboration with the author of the original English version. The system has been modified to work on low cost shared web servers and also to allow the concealment of the randomization sequence.

[Ensayos clínicos publicados en el Boletín Médico del Hospital Infantil de México: un análisis crítico]. / Clinical trials published in the Boletín Médico del Hospital Infantil de México: a critical analysis.

Introducción: El ensayo clínico es la manera más rigurosa de conducir los experimentos en seres humanos. Desde su introducción en investigación biomédica se han implementado cambios en el modo de establecer las bases para el diagnóstico, pronóstico y la terapéutica en la práctica clínica. Se han realizado estudios para identificar los ensayos clínicos publicados en diferentes áreas médicas, pero hasta el momento ninguno había identificado los ensayos clínicos publicados en el Boletín Médico del Hospital Infantil de México (BMHIM). El objetivo de este trabajo fue identificar y describir los ensayos clínicos controlados (ECC) publicados en el BMHIM. Métodos: Se realizó búsqueda manual y sistemática en cada uno de los números y volúmenes del BMHIM de 1968 a 2016. Se registraron los ECC para obtener sus principales características. Adicionalmente, se evaluó su calidad metodológica mediante la herramienta de riesgo de sesgo. Los resultados se presentan de forma descriptiva, gráfica y temporal. Resultados: Se revisaron 73 números con 363 volúmenes, analizando 4925 artículos. La proporción de ECC identificados en el BMHIM fue del 1% (67/4925). En general, los ensayos clínicos se realizaron en el contexto nacional, en el tercer nivel de atención, con un tamaño de muestra reducido, y las intervenciones farmacológicas fueron las más utilizadas. La calidad metodológica de los estudios fue baja, con alto riesgo de sesgo. Conclusiones: Los ensayos clínicos representan el 1% de todos los artículos de investigación originales publicados en el BMHIM. Aún existen áreas de investigación pediátrica, las cuales requieren del desarrollo de ECC para mejorar la práctica clínica, así como para elevar la calidad de la investigación. Background: Controlled clinical trials (CCT) are the study design with the highest accuracy and evidence level. From its introduction in biomedical research, changes have been implemented in the way of establishing the basis for diagnosis, prognosis and treatment in clinical practice. Studies to identify published CCTs regarding different medical fields have been carried out. To date, none of them has identified the clinical trials that have been published in the Boletín Médico del Hospital Infantil de México (BMHIM). The aim of this study was to identify and describe the controlled clinical trials published in the BMHIM. Methods: A manual and systematic search was performed in each of the volumes of the BMHIM from 1968 to 2016. CCTs were recorded to obtain their main characteristics. Additionally, their methodological quality was assessed through the "risk of bias" tool. Results are presented in a descriptive, graphic and time-based manner. Results: In total, 73 issues with 363 volumes were reviewed, and 4925 articles were analyzed. The proportion of CCTs identified in the BMHIM was 1% (67/4925). In general, clinical trials were performed in the national context and in the third-level of medical care. CCTs also presented reduced sample sizes; pharmacological interventions were the most frequent. The methodological quality of the studies was low with a high risk of bias. Conclusions: Clinical trials represented 1% of all the original research articles published in the BMHIM. There are still pediatric research fields that require CCTs to be developed in order to improve clinical practice, as well as to increase the quality of the research.

Ensayos clínicos publicados en el Boletín Médico del Hospital Infantil de México: un análisis crítico / Clinical trials published in the Boletín Médico del Hospital Infantil de México: a critical analysis

Resumen Introducción: El ensayo clínico es la manera más rigurosa de conducir los experimentos en seres humanos. Desde su introducción en investigación biomédica se han implementado cambios en el modo de establecer las bases para el diagnóstico, pronóstico y la terapéutica en la práctica clínica. Se han realizado estudios para identificar los ensayos clínicos publicados en diferentes áreas médicas, pero hasta el momento ninguno había identificado los ensayos clínicos publicados en el Boletín Médico del Hospital Infantil de México (BMHIM). El objetivo de este trabajo fue identificar y describir los ensayos clínicos controlados (ECC) publicados en el BMHIM. Métodos: Se realizó búsqueda manual y sistemática en cada uno de los números y volúmenes del BMHIM de 1968 a 2016. Se registraron los ECC para obtener sus principales características. Adicionalmente, se evaluó su calidad metodológica mediante la herramienta de riesgo de sesgo. Los resultados se presentan de forma descriptiva, gráfica y temporal. Resultados: Se revisaron 73 números con 363 volúmenes, analizando 4925 artículos. La proporción de ECC identificados en el BMHIM fue del 1% (67/4925). En general, los ensayos clínicos se realizaron en el contexto nacional, en el tercer nivel de atención, con un tamaño de muestra reducido, y las intervenciones farmacológicas fueron las más utilizadas. La calidad metodológica de los estudios fue baja, con alto riesgo de sesgo. Conclusiones: Los ensayos clínicos representan el 1% de todos los artículos de investigación originales publicados en el BMHIM. Aún existen áreas de investigación pediátrica, las cuales requieren del desarrollo de ECC para mejorar la práctica clínica, así como para elevar la calidad de la investigación.

Abstract Background: Controlled clinical trials (CCT) are the study design with the highest accuracy and evidence level. From its introduction in biomedical research, changes have been implemented in the way of establishing the basis for diagnosis, prognosis and treatment in clinical practice. Studies to identify published CCTs regarding different medical fields have been carried out. To date, none of them has identified the clinical trials that have been published in the Boletín Médico del Hospital Infantil de México (BMHIM). The aim of this study was to identify and describe the controlled clinical trials published in the BMHIM. Methods: A manual and systematic search was performed in each of the volumes of the BMHIM from 1968 to 2016. CCTs were recorded to obtain their main characteristics. Additionally, their methodological quality was assessed through the "risk of bias" tool. Results are presented in a descriptive, graphic and time-based manner. Results: In total, 73 issues with 363 volumes were reviewed, and 4925 articles were analyzed. The proportion of CCTs identified in the BMHIM was 1% (67/4925). In general, clinical trials were performed in the national context and in the third-level of medical care. CCTs also presented reduced sample sizes; pharmacological interventions were the most frequent. The methodological quality of the studies was low with a high risk of bias. Conclusions: Clinical trials represented 1% of all the original research articles published in the BMHIM. There are still pediatric research fields that require CCTs to be developed in order to improve clinical practice, as well as to increase the quality of the research.

Effectiveness of an intervention to improve diabetes self-management on clinical outcomes in patients with low educational level.

OBJECTIVE: To determine whether an intervention based on patient-practitioner communication is more effective than usual care in improving diabetes self-management in patients with type 2 diabetes with low educational level. METHODS: 12-month, pragmatic cluster randomised controlled trial. Nine physicians and 184 patients registered at two practices in a deprived area of Granada (Andalusia, Spain) participated in the study. Adult patients with type 2 diabetes, low educational level and glycated haemoglobin (HbA1c) > 7% (53.01 mmol/mol) were eligible. The physicians in the intervention group received training on communication skills and the use of a tool for monitoring glycaemic control and providing feedback to patients. The control group continued standard care. The primary outcome was difference in HbA1c after 12 months. Dyslipidaemia, blood pressure, body mass index and waist circumference were also assessed as secondary outcomes. Two-level (patient and provider) regression analyses controlling for sex, social support and comorbidity were conducted. RESULTS: The HbA1c levels at 12 months decreased in both groups. Multilevel analysis showed a greater improvement in the intervention group (between-group HbA1c difference= 0.16; p=0.049). No statistically significant differences between groups were observed for dyslipidaemia, blood pressure, body mass index and waist circumference. CONCLUSIONS: In this pragmatic study, a simple and inexpensive intervention delivered in primary care showed a modest benefit in glycaemic control compared with usual care, although no effect was observed in the secondary outcomes. Further research is needed to design and assess interventions to promote diabetes self-management in socially vulnerable patients.

[Effects of an exercise and relaxation aquatic program in patients with spondyloarthritis: A randomized trial]. / Efectos de un programa de ejercicio físico y relajación en el medio acuático en pacientes con espondiloartritis: ensayo clínico aleatorizado.

BACKGROUND AND OBJECTIVE: Spondyloarthritis is a general term referring to a group of chronic rheumatic illnesses that share clinical, genetic, radiological and epidemiological features. The clinical presentation of spondyloarthritis is characterized by the compromise of both the axial and peripheral articular skeleton. We aimed to evaluate the efficacy of an aquatic exercise plus relaxation program in patients with spondyloarthritis. PATIENTS AND METHOD: This was a randomized single blind study including 30 patients with spondylitis who were randomly assigned to an experimental or control group. For 2 months, the experimental group underwent an aquatic fitness plus relaxation program (3 sessions per week). Evaluations were also performed in the control group the same days as the experimental group but they did not participate in any supervised exercise program. The following data were obtained at baseline and immediately after application of the last session: Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Disease Activity Index, Health Questionnaire SF-12 and Sigma PC3(®) (Sigma-Elektro GmbH, Neustadt, Germany) Heart Rate Monitor. RESULTS: The Mann-Whitney test showed statistically significant differences in the quality of life (physical function [P=.05]), Bath Ankylosing Spondylitis Functional Index (P=.015), Bath Ankylosing Spondylitis Disease Activity Index (fatigue [P=.032], neck pain, back and hips [P=.045], pain or swelling in other joints [P=.032] and in waking morning stiffness [P=.019]). CONCLUSIONS: The results of the present study suggest that therapy with physical exercise plus relaxation provides benefits to spondyloarthritis patients and these are advised as a part of their usual treatment.

Manejo terapéutico de pacientes con fractura del extremo distal de radio mayores de 60 años: revisión sistemática / Treatment of distal radius fractures in patients over 60 years old: a systematic review

The distal radius fracture is a fairly common clinical problem in elderly patients, treatment can be either surgical or conservative. We present a synthesis of evidence relating to compare the functional improvement of both treatment modalities, through a Systematic Review of randomized Clinical Trials. Objective: To determine whether there is scientific to endorse that functional improvement in the medium and long-term conservative versus surgical management in patients with fracture of the distal radius over 60 years. Search Strategy: Were included in Search Randomized Clinical Trials (RCTs), meta analysis (MT) and systematic Reviews (RS), the databases used were Medline, CINALH, Central (Cochrane), Lilacs and PEDro. Results: We selected three RCTs that met the eligibility criteria. Conclusions: There is limited evidence that surgical methods studied did not have better functional outcomes and long-term, compares with a closed reduction and cast. The SF-36 at 3-4 months, gives a DM of 3.01 (-1.6- 7.62), difference is not statistically significant (p = 0.54).

La fractura de radio distal es un problema clínico bastante frecuente en adultos mayores, el tratamiento puede ser de tipo quirúrgico o conservador. Realizaremos una síntesis de la evidencia, relativa a comparar la mejoría funcional de ambas modalidades terapéuticas, a través de una revisión sistemática de Ensayos Clínicos Aleatorizados. Objetivo: Determinar si existe evidencia científica que avale la mejoría funcional a mediano y largo plazo del manejo quirúrgico versus el conservador en pacientes con fractura del extremo distal del radio mayores de 60 años. Estrategia de Búsqueda: Se incluyeron en la búsqueda Ensayos Clínicos Aleatorizados (ECAs), Metaanálisis (MT) y Revisiones Sistemáticas (RS), las Bases de datos usadas fueron: Medline, CINALH, Central (Cochrane), Lilacs y PEDro. Resultados: Se seleccionaron 3 ECAs que cumplían con los criterios de elegibilidad. Conclusiones: Existe limitada evidencia que los métodos quirúrgicos estudiados no presentan mejores resultados funcionales a mediano y largo plazo, comparados con una reducción cerrada más yeso. El SF-36 al 3-4 mes, da una DM de 3,01 (-1,6 - 7,62), diferencia que no es estadísticamente significativa(p = 0,54).