A Controlled Clinical Trial on the Effects of Aquatic Exercise on Cognitive Functions in Community-Dwelling Older Adults.

Several therapies have been developed to reduce cognitive decline associated with aging. Aquatic exercises, which are widely used to enhance functional capacity, may play a role in stimulating cognitive functions. This study investigated the effects of a 3-month aquatic exercise program on cognitive functions in community-dwelling older adults. In this prospective, single-blinded, controlled clinical trial, 31 participants were allocated to either the experimental (aquatic exercises) or control (no-exercise) group. The intervention program consisted of exercises conducted twice a week in a 1.2 m deep indoor pool. The main outcome measures were cognitive functions, assessed using Raven's Progressive Matrices test and the Wisconsin Card Sorting Test. A repeated-measures analysis of variance was used to assess the impact of the exercise program. The effect sizes (η2p) were reported when a level of significance was achieved (p < 0.05). Compared with the control group, the participants who underwent aquatic exercises showed positive outcomes in Raven's Progressive Matrices test (p = 0.046; η2p = 0.131) and the Wisconsin Card Sorting Test (p = 0.001, η2p = 0.589). Complementary analyses of the Wisconsin Card Sorting Test indicated that the benefits of the aquatic exercise were observed in terms of the number of trials (p = 0.001, η2p = 0.478), number of errors (p = 0.001, η2p = 0.458), and number of non-perseverative errors (p = 0.001, η2p = 0.302). The results indicate that a period of three months of aquatic exercise was beneficial for stimulating specific aspects of the cognitive function of community-dwelling older individuals. Aquatic exercise should be prescribed to this population.

¿Ensayos clínicos de superioridad, equivalencia o no inferioridad? / ¿Clinical trials of superiority, non-inferiority or equivalence?

La eficacia de una nueva intervención se establece generalmente a través de ensayos clínicos (EC) con asignación aleatoria (AA). Sin embargo, entre otros tantos desafíos metodológicos, el especificar la hipótesis de un EC con AA, sigue siendo un problema complejo de resolver para los investigadores clínicos. En este manuscrito discutimos las características de tres variantes de los EC con AA: EC de superioridad (ECS), EC de no-inferioridad (ECNI), y EC de equivalencia (ECE). Estos tres tipos de EC tienen supuestos diferentes sobre los efectos de una intervención, por lo que plantear hipótesis y definir objetivos requiere conocer algunos supuestos subyacentes a estos EC, incluso hasta elementos relacionados con la estimación del tamaño de muestra para cada cual. El objetivo de este manuscrito fue describir las diferencias metodológicas entre ECS, ECNI y ECE.

Efficacy and effectivity of new interventions are generally established through randomized clinical trials (RCTs). However, among many other methodological challenges, specifying the hypothesis of a RCT remains complex problem for clinical researchers. In this manuscript we discuss the characteristics of three variants of RCTs: superiority RCT (SRCT), non-inferiority RCT (NIRCT), and equivalence RCT (ERCT). These three types of RCT have different assumptions about the effects of an intervention, so setting hypotheses and defining objectives requires knowing some assumptions underlying these RCTs, including elements related to the estimation of the sample size for each one. The aim of this manuscript was to describe methodological differences between SRCT, NIRCT and ERCT.

Electroacupuncture efficacy in diabetic polyneuropathy: Study protocol for a double-blinded randomized controlled multicenter clinical trial.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus (T2DM); its diagnosis and treatment are based on symptomatic improvement. However, as pharmacological therapy causes multiple adverse effects, the implementation of acupunctural techniques, such as electroacupuncture (EA) has been suggested as an alternative treatment. Nonetheless, there is a lack of scientific evidence, and its mechanisms are still unclear. We present the design and methodology of a new clinical randomized trial, that investigates the effectiveness of EA for the treatment of DPN. METHODS: This study is a four-armed, randomized, controlled, multicenter clinical trial (20-week intervention period, plus 12 weeks of follow-up after concluding intervention). A total of 48 T2DM patients with clinical signs and symptoms of DPN; and electrophysiological signs in the Nerve Conduction Study (NCS); will be treated by acupuncture specialists in outpatient units in Mexico City. Patients will be randomized in a 1:1 ratio to one of the following four groups: (a) short fibre DPN with EA, (b) short fibre DPN with sham EA, (c) axonal DPN with EA and (d) axonal DPN with sham EA treatment. The intervention will consist of 32 sessions, 20 min each, per patient over two cycles of intervention of 8 weeks each and a mid-term rest period of 4 weeks. The primary outcome will be NCS parameters, and secondary outcomes will include DPN-related symptoms and pain by Michigan Neuropathy Screening Instrument (MNSI), Michigan Diabetic Neuropathy Score (MDNS), Dolour Neuropatique Score (DN-4), Semmes-Westein monofilament, Numerical Rating Scale (NRS) for pain assessment, and the 36-item Short Form Health Survey (SF-36). To measure quality of life and improve oxidative stress, the inflammatory response; and genetic expression; will be analysed at the beginning and at the end of treatment. DISCUSSION: This study will be conducted to compare the efficacy of EA versus sham EA combined with conventional diabetic and neuropathic treatments if needed. EA may improve NCS, neuropathic pain and symptoms, oxidative stress, inflammatory response, and genetic expression, and it could be considered a potential coadjutant treatment for the management of DPN with a possible remyelinating effect. TRIAL REGISTRATION: ClinicalTrials.gov. NCT05521737 Registered on 30 August 2022. International Clinical Trials Registry Platform (ICTRP) ISRCTN97391213 Registered on 26 September 2022 [2b].

The efficacy of hypnosis compared with the tell/show/do technique for the reduction of anxiety/pain in children undergoing pulpotomies: a randomized controlled trial.

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.

Eficacia y seguridad del supositorio Proctokinasa® en el tratamiento de la enfermedad inflamatoria pélvica aguda

Introducción: La enfermedad inflamatoria pélvica aguda es una entidad frecuente en mujeres jóvenes en edad reproductiva, y constituye la causa principal de infertilidad. La búsqueda de un tratamiento antiinflamatorio eficaz y seguro que alivie el dolor, evite complicaciones y secuelas, es una prioridad para su tratamiento. Objetivo: Evaluar la eficacia y seguridad del tratamiento con Proctokinasa® en la enfermedad inflamatoria pélvica aguda grados I y II. Materiales y métodos: Se desarrolló un ensayo clínico, controlado, abierto, de enero de 2017 a enero de 2018, que incluyó 76 pacientes con diagnóstico de enfermedad inflamatoria pélvica aguda en la atención primaria de salud, quienes fueron asignadas aleatoriamente a dos grupos de tratamiento: grupo principal Proctokinasa®, que recibió una unidad/8 h por 2 días, y el grupo Piroxicam, un supositorio de 20 mg/24 h por 7 días. La antibioticoterapia oral recomendada se inició simultáneamente. Se evaluó la respuesta clínica y ecográfica al tratamiento. Los eventos adversos fueron evaluados. Resultados: Se constató respuesta clínica a partir de las 72 horas de tratamiento en más del 50 % de las pacientes en ambos grupos, y fue del 100 % de los casos para el grupo Proctokinasa® en las dos últimas evaluaciones realizadas (días 10 y 15). Se evidenció la remisión de las alteraciones ecográficas en el 96,9 % del grupo Proctokinasa®. Los eventos adversos fueron escasos y leves. Conclusiones: El empleo de Proctokinasa® resultó eficaz y seguro en el tratamiento de la enfermedad inflamatoria pélvica aguda grados I y II.

Introduction: Acute pelvic inflammatory disease is a common entity in young women of reproductive age and it is a leading cause of infertility. The search for an effective and safe anti-inflammatory treatment that relieves pain, avoids complications and sequels, it is priority for its treatment. Objective: To evaluate the efficacy and safety of the treatment with Proctokinasa® in acute pelvic inflammatory disease grades I and II. Materials and methods: An open, controlled clinical trial was carried out from January 2017 to January 2018 which included 76 patients diagnosed with acute pelvic inflammatory disease in primary health care; they were randomize assigned to two treatment groups: Proctokinasa® main group, who received one unity/8h for 2 days, and the Piroxican group, 1 suppository of 20 mg/24h per 7 days. The recommended oral antibiotic therapy was started simultaneously. Clinical and ultrasound response to treatment were evaluated. Adverse events were evaluated. Results: Clinical response was stated after 72 hours of treatment inmore than 50% of the patients in both groups, and it was 100% for the Proctokinasa® group in the last two evaluations (days 10 and 15). Remission of ultrasound alterations was evident in 96.9% of the Proctokinasa® group. Adverse events were few and mild. Conclusions: The use of Proctokinasa® was effective and safe in the treatment of acute pelvic inflammatory disease grades I and II.

Efficacy of Transcranial Direct Current Stimulation (tDCS) on Cognition, Anxiety, and Mobility in Community-Dwelling Older Individuals: A Controlled Clinical Trial.

Transcranial direct current stimulation (tDCS) has gained popularity as a method of modulating cortical excitability in people with physical and mental disabilities. However, there is a lack of consensus on its effectiveness in older individuals. This study aimed to assess the efficacy of a 2-month tDCS program for improving physical and mental performance in community-dwelling older individuals. In this single-blinded, controlled clinical trial, forty-two participants were allocated to one of three groups: (1) the tDCS group, which received, twice a week, 20 min sessions of 2 mA electric current through electrodes placed on the dorsolateral prefrontal cortex; (2) the tDCS-placebo group, which underwent the same electrode placement as the tDCS group but without actual electric stimulation; and (3) the cognitive-control group, which completed crossword puzzles. Main outcome measures were cognition, mobility, and anxiety. Multivariate analyses of variance were employed. Significance was set at 5% (p < 0.05). Regarding the results, no significant benefits were observed in the tDCS group compared with the tDCS-placebo or cognitive-control groups for cognition (p = 0.557), mobility (p = 0.871), or anxiety (p = 0.356). Cognition exhibited positive oscillations during the assessments (main effect of time: p = 0.001). However, given that all groups showed similar variations in cognitive scores (main effect of group: p = 0.101; group × time effect: p = 0.557), it is more likely that the improvement reflects the learning response of the participants to the cognitive tests rather than the effect of tDCS. In conclusion, a 2-month tDCS program with two sessions per week appears to be ineffective in improving physical and mental performance in community-dwelling older individuals. Further studies are necessary to establish whether or not tDCS is effective in healthy older individuals.

Dental aesthetic perception of patients submitted to activated charcoal-based bleaching agents: A randomized clinical trial.

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.

The effect of a multicomponent oral care regimen on gingival inflammation: A randomized controlled clinical trial.

BACKGROUND: Oral care regimens can be explored to improve oral health in patients with gingivitis. This study aimed to evaluate the efficacy of a multicomponent oral care regimen with a dual zinc plus arginine (DZA) toothpaste and cetylpyridinium chloride with zinc lactate (CPC + Zn) mouthwash in reducing gingival bleeding in patients with gingivitis. METHODS: This randomized clinical trial included 94 participants with gingivitis who were randomized into two groups: the DZA/CPC + Zn group, which used a 1450-ppm fluoride toothpaste containing 0.96% zinc plus 1.5% arginine and a fluoride-containing mouthwash with 0.075% CPC and 0.28% zinc lactate, and the control group, which used a 1450-ppm fluoride toothpaste and a placebo mouthwash for 6 months. All participants were examined by a blinded examiner who measured the gingival index, plaque index, and gingival severity index. Data were analyzed using paired t test, independent t test, and analysis of covariance (ANCOVA). RESULTS: Both groups presented statistically significant reductions in all clinical parameters compared to baseline. The DZA/CPC + Zn group exhibited significantly greater reductions in gingival index, gingival severity index, proximal gingival index, plaque index and proximal plaque index compared to the control group at 1, 3, and 6 months. Furthermore, DZA/CPC + Zn significantly decreased the percentage of patients with generalized gingivitis over a 6-month follow-up period. However, differences between the DZA/CPC + Zn and the control groups were not maintained after both groups established similar regimens with fluoride toothpaste. CONCLUSION: The multicomponent oral care regimen consisting of DZA toothpaste and CPC + Zn mouthwash is effective in reducing gingival inflammation and supragingival biofilm in patients with gingivitis.

Ensayo clínico controlado aleatorio de dos técnicas quirúrgicas para pterigión primario en pacientes de la selva: cauterización versus sutura / Randomized Controlled Clinical Trial of Two Surgical Techniques for Primary Pterygium in Jungle Patients: Cauterization versus Suturing

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.

Radiographic outcomes of ridge reconstruction with autogenous bone block versus collagenated xenogeneic bone block: A randomized clinical trial.

AIM: To compare, at different levels from the alveolar crest, the radiographic outcomes of equine-derived collagenated xenogeneic bone blocks (CXBB) and autogenous bone blocks (ABB) used for lateral alveolar ridge augmentation. MATERIALS AND METHODS: Sixty-four patients with tooth gaps in atrophic alveolar ridges with ≤4 mm were randomly assigned to lateral augmentation using CXBB or ABB. The lateral bone thickness (LBT) was measured 2, 4, 6, 8, and 10 mm below the alveolar crest using CBCT scans obtained before augmentation surgery and at 30 weeks, prior to implant placement. Statistical analysis was performed using Shapiro-Wilk, Fisher's exact, Mann-Whitney, and Wilcoxon signed-rank tests. RESULTS: Both CXBB and ABB resulted in significant total and buccal LBT gains at 2, 4, 6, 8, and 10 mm. LBT gains were similar between CXBB- and ABB-augmented sites, except for greater buccal LBT gains at 8 mm at CXBB-augmented sites. While ABB-augmented sites gained vertical bone height, CXBB-treated sites suffered vertical bone loss (CXBB: -0.16 mm; ABB: 0.38 mm, p < .0009). CONCLUSIONS: CXBB and ABB were both associated with significant and similar LBT gains at 30 weeks.

A phase 3, randomised, double-blind, placebo-controlled clinical trial evaluation of the efficacy and safety of a SARS-CoV-2 recombinant spike RBD protein vaccine in adults (ABDALA-3 study).

Background: The pandemic of COVID-19 raised the urgent need for safe and efficacious vaccines against SARS-CoV-2. We evaluated the efficacy and safety of a new SARS-CoV-2 virus receptor-binding domain (RBD) vaccine. Methods: A phase 3, multicentre, randomised, double-blind, placebo-controlled trial was carried out at 18 clinical sites in three provinces of the south-eastern region of Cuba. Subjects (healthy or those with controlled chronic diseases) aged between 19 and 80 years, who gave written informed consent were eligible. Subjects were randomly assigned (1:1, in blocks) to two groups: placebo, and 50 µg RBD vaccine (Abdala). The product was administered intramuscularly, 0.5 mL in the deltoid region, in a three-dose immunization schedule at 0-14-28 days. The organoleptic characteristics and presentations of the vaccine and placebo were identical. All participants (subjects, clinical researchers, statisticians, laboratory technicians, and monitors) remained blinded during the study period. The main endpoint was to evaluate the efficacy of the Abdala vaccine in the prevention of symptomatic COVID-19. The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000359. Findings: Between March 22 to April 03, 2021, 48,290 subjects were included (24,144 and 24,146 in the placebo and Abdala groups, respectively) in the context of predominant D614G variant circulation. The evaluation of the main efficacy outcomes occurred during May-June 2021, starting at May 3rd, in the context of high circulation of mutant viruses, predominantly VOC Beta. The incidence of adverse reactions for individuals in the placebo and Abdala vaccine groups were 1227/24,144 (5.1%) and 1621/24,146 (6.7%), respectively. Adverse reactions were mostly mild, and from the injection site, which resolved in the first 24-48 h. No severe adverse events with demonstrated cause-effect relationship attributable to the vaccine were reported. Symptomatic COVID-19 disease was confirmed in 142 participants in the placebo group (78.44 incidence per 1000 person-years, 95% confidence interval [CI], 66.07-92.46) and in 11 participants in Abdala vaccine group (6.05 incidence per 1000 person years; 95% CI 3.02-10.82). The Abdala vaccine efficacy against symptomatic COVID-19 was 92.28% (95% CI 85.74-95.82). Moderate/serious forms of COVID-19 occurred in 30 participants (28 in the placebo group and only 2 in the Abdala vaccine group) for a vaccine efficacy of 92.88% (95% CI 70.12-98.31). There were five critical patients (of which four died), all in the placebo group. Interpretation: The Abdala vaccine was safe, well tolerated, and highly effective, fulfilling the WHO target product profile for COVID-19 vaccines. Those results, along with its immunization schedule and the advantage of easy storage and handling conditions at 2-8 °C, make this vaccine an option for the use in immunization strategies as a key tool for the control of the pandemic. Funding: Centre for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.

Effects of multiwavelength photobiomodulation for the treatment of traumatic soft tissue injuries associated with bone fractures: A double-blind, randomized controlled clinical trial.

This study evaluated the efficacy and safety of multiwavelength photobiomodulation (MPBM) in healing soft tissue injuries associated with tibial and/or ankle fractures. Participants were randomized into the MPBM or control group. Primary outcome was wound healing, measured by the Bates-Jensen scale. Assessments were performed daily. Twenty-seven hospitalized adults were included. MPBM showed an improvement in the daily mean Bates-Jensen scale (MPBM 32.1 vs. control 34.2; p = 0.029), daily mean pain score change (MPBM 0.5 vs. control 0.2; p = 0.04) and occurrence of infection at the site of the external fixator pins (MPBM 15.3% vs. control 57.1%; p = 0.02). MPBM group also showed faster-wound resolution (MPBM 13.1 vs. control 23.1 days). Subgroup analysis showed improvement in the MPBM group among less severe patients on the Bates-Jensen scale (MPBM 27.4 vs. control 34.7; p = 0.0081) and mean time for wound resolution (MPBM 7.0 vs. control 14.6 days; p = 0.03). MPBM appears safe and effective in reducing wound resolution time, infection in the surgical pin sites, reported pain and time before definitive surgery.

Educational intervention for the maintenance of exclusive breastfeeding in adolescent mothers: A feasibility study.

PURPOSE: The purpose of this study was to evaluate the feasibility of implementing the nursing intervention Breastfeeding Counseling (5244) in first-time adolescent mothers and its effect on the knowledge and maintenance of exclusive breastfeeding in the first 6 months of life. METHODS: Randomized, controlled feasibility study with 166 first-time mothers between 14 and 19 years of age, from 20 to 30 weeks of gestation, assigned to an experimental group (nursing intervention: breastfeeding counseling) or a control group (usual education plus nursing intervention not related to breastfeeding). The rate of abandonment of exclusive breastfeeding and the level of knowledge about breastfeeding were evaluated. FINDINGS: The inclusion was 91.7% (166/181), dropout during the intervention was 39.75% (n = 66), and loss in the follow-up was 8.43% (n = 14). Compliance with the intervention protocol was 100%. The pregnant women and family members were satisfied with the intervention and perceived the health benefits for the mothers and their children. Outcome measures in the experimental group did not reveal a significant effect on breastfeeding abandonment rates at 2, 4, and 6 months postpartum, but they did manage to improve and maintain the level of knowledge about breastfeeding. CONCLUSIONS: It was found that it is feasible to implement the nursing intervention: "Breastfeeding counseling" in prenatal classes, achieving an increase in the level of knowledge about breastfeeding in adolescent mothers, but without a reduction in the rate of abandonment of breastfeeding. Nursing professionals need to know and address barriers to exclusive breastfeeding in adolescents. IMPLICATIONS FOR NURSING PRACTICE: The nursing intervention "Breastfeeding counseling (5244)" and the outcome "Knowledge: Breastfeeding (1800)" supported the processes of education and knowledge assessment on breastfeeding in pregnant adolescents, which should be instituted in perinatal nursing care.

OBJETIVO: Evaluar la factibilidad en la implementación de la intervención de enfermería Asesoramiento en la lactancia (5244), en madres adolescentes primerizas y su efecto en el conocimiento y mantenimiento de la lactancia materna exclusiva en los primeros seis meses de vida. MÉTODOS: Estudio de factibilidad controlado aleatorizado con 166 madres primigestantes entre 14 y 19 años, de 20 a 30 semanas de gestación, asignadas a un grupo experimental (intervención de enfermería: asesoramiento en la lactancia) o a un grupo control (educación habitual más intervención de enfermería no relacionada con la lactancia materna). Se evaluó la tasa de abandono de la lactancia materna exclusiva y el nivel de conocimiento sobre la lactancia. RESULTADOS: La inclusión fue del 91.7% (166/181), la deserción durante la intervención del 39.75% (n = 66) y en el seguimiento del 8.43% (n = 14). El cumplimiento del protocolo de intervención fue del 100%. Las gestantes y familiares se encontraron satisfechos con la intervención y percibieron los beneficios en la salud de las madres y sus hijos. Las medidas de resultado en el grupo experimental no revelaron un efecto significativo en las tasas de abandono de lactancia materna a los 2,4 y 6 meses posparto, pero sí logró mejorar y mantener el nivel de conocimientos sobre lactancia materna. CONCLUSIONES: Se encontró que es factible implementar la intervención de enfermería: "Asesoramiento en la lactancia" en las clases prenatales, logrando incrementar el nivel de conocimientos sobre lactancia en las madres adolescentes, pero sin disminución de la tasa de abandono de la lactancia materna. Los profesionales de enfermería requieren conocer y abordar las barreras para la lactancia exclusiva en adolescentes. IMPLICACIONES PARA LA PRÁCTICA DE ENFERMERÍA: La intervención de enfermería "Asesoramiento en la lactancia (5244)" y el resultado "Conocimiento: lactancia materna (1800)" apoyaron los procesos de educación y evaluación del conocimiento sobre lactancia materna en gestantes adolescentes, por lo cual deberían ser instituidos en el cuidado de enfermería materno perinatal.

Ensayo controlado y aleatorizado del uso de Heberkinasa® en el derrame pleural paraneumónico en niños / Randomized Controlled Trial of the Use of Heberkinase® in Parapneumonic Pleural Effusion in Children

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)

Effect of the association of continuous shortwave diathermy and Pilates-based exercises on pain, depression, and anxiety in chronic non-specific low back pain: a randomized clinical trial

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.

Reflexiones acerca de las cambiantes narrativas sobre las vacunas contra la COVID-19

Nos propusimos discernir en qué medida las estrategias mediáticas adoptadas en torno a las vacunas contra la COVID-19, a lo largo de los primeros 15 meses desde el comienzo de su aplicación, pueden considerarse aportes legítimos y coherentes para comprender mejor su desempeño, y en qué grado las narrativas elaboradas pudieran responder a intereses económicos de las élites corporativas. Una vez recopilados los elementos más relevantes con que se configuran las narrativas predominantes desde el momento en que se concibieron las vacunas, se identificaron diversas anomalías que resultaron, en mayor o menor medida, invisibilizadas en el proceso de su aprobación y de los resultados de su aplicación. Las más significativas conciernen al manejo de las definiciones, los incumplimientos de compromisos y los conflictos de interés que comprometen la actuación de las empresas comercializadoras y los entes reguladores de las vacunas. Numerosos elementos relacionados con los intereses corporativos han gravitado en la elaboración del relato sobre las vacunas. Entre los que reclaman resignificación se hallan: su capacidad preventiva real de contagios, evoluciones graves y muertes, su eficacia ante nuevas variantes, la duración de la inmunidad que confieren, sus efectos adversos, el papel sinérgico de la inmunidad adquirida y los recursos empleados por las empresas para conseguir un predominio virtualmente monopólico en el mercado.

We set out to discern to what extent the media strategies adopted around the vaccines against covid-19 during the first 15 months since the beginning of their application can be considered as a legitimate and coherent contributions to a better understanding about their performance and to what extent the elaborated discourses could respond to the economic interests of the corporations' elites. Once the most relevant elements that have shaped the predominant narratives from the moment the vaccines were conceived were compiled, several anomalies were identified that were to a greater or lesser extent invisibilized in the process of their approval and the results of their application. The most significant of these concern the handling of definitions, non-compliance with commitments and conflicts of interest that compromise the actions of vaccine marketing companies and regulatory bodies. Many elements related to corporative interests have influenced the narrative concerning vaccines. Among those that require a resignification are: their real preventive capacity against contagions, serious diseases and deaths, their efficacy against new variants, the duration of the immunity they confer, their side effects, the synergic role of acquired immunity, and the resources used by the companies to achieve a virtually market monopolistic predominance.

Propomo-nos discernir em que medida as estratégias mediáticas adotadas em torno das vacinas covid-19, ao longo dos primeiros 15 meses desde o início da sua aplicação, podem dar contribuições legítimas e coerentes para melhor compreender o seu desempenho, e em que medida as narrativas poderiam responder aos interesses econômicos das elites corporativas. Uma vez compilados os elementos mais relevantes com os quais se configuram as narrativas predominantes desde o momento em que as vacinas foram concebidas, foram identificadas diversas anomalias que foram, em maior ou menor medida, invisibilizadas no processo de sua aprovação e nos resultados de sua aplicação . As mais significativas dizem respeito à gestão de definições, descumprimentos de compromissos e conflitos de interesse que comprometem a atuação das empresas comercializadoras e dos órgãos reguladores das vacinas. Inúmeros elementos relacionados a interesses corporativos gravitaram na elaboração da história sobre vacinas. Entre os que demandam ressignificação estão: sua real capacidade preventiva de contágios, evoluções graves e óbitos, sua eficácia contra novas variantes, a duração da imunidade que se consolidou, seus efeitos adversos, o papel sinérgico da imunidade adquirida e os recursos utilizados. empresas para alcançar o domínio do monopólio virtual no mercado.

Efficacy and safety of neuromuscular electrical stimulation in the prevention of pressure injuries in critically ill patients: a randomized controlled trial.

BACKGROUND: Pressure injuries (PIs), especially in the sacral region are frequent, costly, and increase morbidity and mortality of patients in an intensive care unit (ICU). These injuries can occur as a result of prolonged pressure and/or shear forces. Neuromuscular electrical stimulation (NMES) can increase muscle mass and improve local circulation, potentially reducing the incidence of PI. METHODS: We performed a randomized controlled trial to assess the efficacy and safety of NMES in preventing PI in critically ill patients. We included patients with a period of less than 48 h in the ICU, aged ≥ 18 years. Participants were randomly selected (1:1 ratio) to receive NMES and usual care (NMES group) or only usual care (control group-CG) until discharge, death, or onset of a PI. To assess the effectiveness of NMES, we calculated the relative risk (RR) and number needed to treat (NNT). We assessed the muscle thickness of the gluteus maximus by ultrasonography. To assess safety, we analyzed the effects of NMES on vital signs and checked for the presence of skin burns in the stimulated areas. Clinical outcomes were assessed by time on mechanical ventilation, ICU mortality rate, and length of stay in the ICU. RESULTS: We enrolled 149 participants, 76 in the NMES group. PIs were present in 26 (35.6%) patients in the CG and 4 (5.3%) in the NMES group (p ˂ 0.001). The NMES group had an RR = 0.15 (95% CI 0.05-0.40) to develop a PI, NNT = 3.3 (95% CI 2.3-5.9). Moreover, the NMES group presented a shorter length of stay in the ICU: Δ = - 1.8 ± 1.2 days, p = 0.04. There was no significant difference in gluteus maximus thickness between groups (CG: Δ = - 0.37 ± 1.2 cm vs. NMES group: Δ = 0 ± 0.98 cm, p = 0.33). NMES did not promote deleterious changes in vital signs and we did not detect skin burns. CONCLUSIONS: NMES is an effective and safe therapy for the prevention of PI in critically ill patients and may reduce length of stay in the ICU. Trial registration RBR-8nt9m4. Registered prospectively on July 20th, 2018, https://ensaiosclinicos.gov.br/rg/RBR-8nt9m4.

Positive perception and efficacy of compression stockings for prevention of lower limb edema in pregnant women.

Background: Pregnancy is characterized by physiological changes that can contribute to development of varicose veins, venous insufficiency, and leg edema. Objectives: To evaluate the effect of compression stocking on lower limb edema in pregnant women and their perceptions of wearing them. Methods: This was a randomized, controlled, prospective, parallel, blinded clinical trial conducted with 60 pregnant women randomly distributed into two groups: an intervention group (n = 30) wearing compression stockings and a control group (n = 30). Standardized ankle and calf measurements were taken of all 120 lower limbs using a tape measure. At the end of the study, a questionnaire was administered to identify perceived difficulties and advantages related to wearing compression stockings. Results: Pregnant women in the intervention group had a significantly smaller increase (p < 0.05) in calf and ankle diameters compared to those in the control group. The mean differences from the beginning to the end of gestation in the diameters of the right calf, left calf, right ankle, and left ankle respectively were 0.30 cm, 0.30 cm, 0.15, cm and 0.15 cm in the intervention group and 1.95 cm, 1.95 cm, 1.73 cm, and 1.87 cm in the control group. Most of the pregnant women had no difficulty wearing the compression stockings and all reported that they felt a difference in leg symptoms and would wear stockings again. Conclusions: Compression stockings were effective for preventing lower limb edema in pregnant women, who had a positive perception of wearing them.

Estudos experimentais desenvolvidos por enfermeiros brasileiros: revisão integrativa / Experimental studies developed by brazilian nurses: integrative review / Estudios experimentales desarrollados por enfermeros brasileños: revisión integradora

Objetivo: descrever a produção nacional da Enfermagem brasileira de estudos experimentais publicados nos últimos cinco anos. Método: revisão integrativa realizada nas bases de dados MEDLINE, Embase, CINAHL e Scopus e na Biblioteca Virtual em Saúde. Para a estratégia de busca, utilizaram-se os descritores: "Ensaio Clínico Controlado", "Ensaio Clínico", "Ensaio Clínico Controlado Aleatório" e "Pesquisa em Enfermagem". Incluíram-se: artigos originais publicados entre os anos de 2015 e 2020, em português, inglês e/ou espanhol, tendo enfermeiros como primeiro autor e com pontuação cinco no escore de Jadad. Resultados: foram analisados 16 artigos, com escore cinco na escala de Jadad, que contemplam três premissas: randomização, cegamento e descrição de perdas adequadamente. Identificaram-se quatro grandes áreas de conhecimento: práticas integrativas, saúde do adulto-idoso, saúde maternoinfantil e estomaterapia. Na temática de práticas integrativas, os estudos demonstraram a eficácia dessas práticas, enquanto, na área de saúde adulto-idoso e maternoinfantil, prevaleceram estudos de intervenções educativas; estudos de estomaterapia abordaram terapias tópicas que auxiliam no processo de cicatrização tecidual/prevenção de lesões de pele. Conclusão: identificou-se que o principal enfoque dos estudos com o método experimental por enfermeiros brasileiros pertencia a quatro grandes áreas de conhecimento da saúde e abordaram questões educativas e intervenções clínicas da prática da Enfermagem.(AU)

Objective: to describe the national production of Brazilian Nursing experimental studies published in the last five years. Method: integrative review conducted in the MEDLINE, Embase, CINAHL and Scopus databases and in the Virtual Health Library. For the search strategy, the following descriptors were used: "Controlled Clinical Trial", "Clinical Trial", "Randomized Controlled Clinical Trial" and "Nursing Research". Included were: original articles published between the years 2015 and 2020, in Portuguese, English and/or Spanish, with nurses as first author and with a score of five in the Jadad. Results: a total of 16 articles were analyzed, with a score of five on the Jadad scale, which contemplate three premises: randomization, blinding, and adequate description of losses. Four major areas of knowledge were identified: integrative practices, adult and elderly health, maternal and child health, and stoma therapy. In the theme of integrative practices, the studies demonstrated the effectiveness of these practices, while in the area of adult-elderly and maternal-infant health, studies of educational interventions prevailed; stoma therapy studies addressed topical therapies that assist in the process of tissue healing/prevention of skin lesions. Conclusion: it was identified that the main focus of studies with the experimental method by Brazilian nurses belonged to four major areas of health knowledge and addressed educational issues and clinical interventions in Nursing practice.(AU)

Objetivo: describir la producción nacional de Enfermería brasileña de estudios experimentales publicados en los últimos cinco años. Método: revisión integradora realizada en las bases de datos MEDLINE, Embase, CINAHL y Scopus y en la Biblioteca Virtual en Salud. Para la estrategia de búsqueda se utilizaron los siguientes descriptores: "Ensayo Clínico Controlado", "Ensayo Clínico", "Ensayo Clínico Controlado Aleatorio" e "Investigación en Enfermería". Se incluyeron: artículos originales publicados entre 2015 y 2020, en portugués, inglés y/o español, con enfermeros como primer autor y con puntuación de cinco en la escala de Jadad. Resultados: se analizaron 16 artículos, con puntaje de cinco en la escala de Jadad, que incluyen tres premisas: aleatorización, cegamiento y descripción de las pérdidas adecuadamente. Se identificaron cuatro grandes áreas de conocimiento: prácticas integradoras, salud adulto-anciano, salud materno-infantil y estomaterapia. En el área de prácticas integradoras, los estudios demostraron la efectividad de estas prácticas, mientras que, en el área de salud adultoanciano y materno-infantil, prevalecieron los estudios de intervenciones educativas; Los estudios de estomaterapia han abordado terapias tópicas que ayudan en el proceso de curación de tejidos/prevención de lesiones en la piel. Conclusión: se identificó que el foco principal de los estudios con el método experimental de los enfermeros brasileños pertenecía a cuatro grandes áreas del conocimiento en salud y abordaron cuestiones educativas e intervenciones clínicas en la práctica de Enfermería.(AU)

Compreensão do consentimento informado em pesquisa clínica de vacina contra o Zika vírus: estudo transversal / Understanding of informed consent in clinical research for a vaccine against Zika virus: a cross-sectional study / Comprensión del consentimiento informado en la investigación clínica de una vacuna contra el virus del Zika: un estudio transversal

OBJETIVO: avaliar a compreensão das informações do Termo de Consentimento Livre e Esclarecido pelos participantes de uma pesquisa clínica de vacina contra o Zika vírus. MÉTODO: estudo transversal com amostra por conveniência e participação de 101 voluntários de uma pesquisa clínica em Belo Horizonte, Minas Gerais. Utilizou-se um questionário estruturado. A análise dos dados foi realizada no programa R, segundo a estatística descritiva e inferencial. RESULTADOS: a média de acertos dos participantes sobre as informações do documento de consentimento foi de 66,9%. A maioria dos participantes assinou o documento sem o conhecimento suficiente das informações da pesquisa. O Índice de compreensão foi maior entre os participantes que tinham se voluntariado em pesquisas prévias (p=0,039). CONCLUSÃO: verificaram-se limitações importantes na compreensão dos participantes sobre informações do termo de consentimento, o que comprometeu a decisão autônoma. São necessárias adaptações e melhorias nos processos de consentimento informado em prol da sua validade.

OBJECTIVE: to assess the understanding of the information contained in the Informed Consent Form by the participants of a clinical trial of a vaccine against the Zika virus. METHOD: cross-sectional study using intentional sampling, including a total of 101 volunteers in clinical research in Belo Horizonte, Minas Gerais. A structured questionnaire was used. Data analysis was performed using R software, according to descriptive and inferential statistics. RESULTS: the mean of correct answers of the participants regarding the information in the consent form was 66.9%. Most participants signed the document without sufficient knowledge of the research information. The comprehension index was higher among participants who had volunteered in previous research (p=0.039). CONCLUSION: there were important limitations in the participants' understanding of information in the consent form, which compromised the autonomous decision. Adaptations and improvements are necessary in the processes of informed consent for its validity.

OBJETIVO: evaluar la comprensión de las informaciones contenidas en el Término de Consentimiento Libre e Informado por los participantes de un ensayo clínico de una vacuna contra el virus del Zika. MÉTODO: estudio transversal con muestra de conveniencia y participación de 101 voluntarios en una investigación clínica en Belo Horizonte, Minas Gerais. Se utilizó un cuestionario estructurado. El análisis de datos se realizó mediante el programa R, según estadística descriptiva e inferencial. RESULTADOS: el promedio de aciertos de los participantes con respecto a las informaciones del documento de consentimiento fue de 66,9%. La mayoría de los participantes firmó el documento sin conocimiento suficiente de las informaciones de la investigación. El índice de comprensión fue mayor entre los participantes que se habían ofrecido como voluntarios en investigaciones anteriores (p=0,039). CONCLUSIÓN: hubo limitaciones importantes en la comprensión de las informaciones del formulario de consentimiento por parte de los participantes, lo que comprometió la decisión autónoma. Son necesarias adecuaciones y mejoras en los procesos de consentimiento informado para su validez.