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Copyright of Portuguese Journal of Mental Health Nursing / Revista Portuguesa de Enfermagem de Saúde Mental is the property of Portuguese Society of Mental Health Nursing and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

ABSTRACT Objective: to assess the effectiveness of 5% Brazilian green propolis (ointment) in individuals with chronic ulcers. Methods: a randomized clinical trial, developed with 40 patients randomized equally to control group (treated with essential fatty acid) and experimental group (treated with 5% green propolis) for 30 days. The outcomes of interest were sociodemographic, clinical and laboratory characteristics, lesion characteristics, such as type of tissue in the bed, presence of exudate, edge characteristics, microbial content and pain. Results: regarding sociodemographic, clinical and laboratory characteristics, the two groups did not show statistically significant differences. After assessment in 30 days, an effect was observed for both treated groups, but for the experimental group, greater effectiveness in terms of the type of tissue in the bed, type of exudate, edge characteristics, microbial content and pain. Conclusion: propolis-based ointment showed a healing effect, presenting itself as a potential tool in healing chronic ulcers.

Objective: to evaluate the effect of an educational video on the knowledge, attitude, and practice of self-care with arteriovenous fistula in patients undergoing hemodialysis treatment. Method: randomized controlled clinical trial, with two arms and single-blind. The intervention used an educational video on arteriovenous fistula self-care. The Fistula Self-Care Knowledge, Attitude, and Practice Scale was applied to 27 renal patients on hemodialysis in the control group and 28 in the intervention group at baseline, after seven and fourteen days. The data was analyzed using the Statistical Package for the Social Sciences software, using the chi-square test, Student’s t-test, Mann-Whitney test, and Friedman’s test with post-hoc analysis for multiple comparisons. Results: there were statistically significant differences in the knowledge and practice of self-care with the fistula at 0, 7 and, 14 days in the intervention (p= 0.004 and p

Introduction: Recent studies have related the climacteric period with changes in connective tissue elasticity that may be related to diastasis recti abdominis. Mat Pilates is a method of exercise without impact that currently has more practitioners, due to its satisfactory results. However, there are no studies that evaluate the effectiveness of mat Pilates for women with diastasis recti abdominis. Objective: To evaluate the effectiveness of the mat Pilates program in climacteric women with diastasis recti abdominis. Methods: This randomized single-blinded clinical trial evaluated climacteric women with diastasis recti abdominis. The participants were randomized into the experimental group, which participated in 3 weekly sessions of mat Pilates for 12 weeks for a total of 36 sessions, and the control group (without exercises). The inter-rectus distance was measured with a digital caliper. The G*Power Version 3.1.9.2. software was used for the sample calculation, and the SPSS 20.0 program was used for statistical analysis. Results: The study comprised 21 women, including 10 in the control group and 11 in the experimental group, with mean ages of 54.3 ± 7.1 and 55.3 ± 6.0 years and body mass index values of 28.8 ± 5.5 kg/m2 and 29.9 ± 4.48 kg/m2, respectively. In the experimental group, reductions were observed in all the measures related to diastasis recti abdominis (p

Abstract Objectives: to evaluate the effect of oropharyngeal colostrum immunotherapy on the length of hospital stay in preterm newborns with very low birth weight. Methods: interventional ambispective study, which consisted of eight daily administrations of 0.2 ml (four drops) of colostrum, totaling up to 56 syringes (for up to seven days). The control was historic. The main independent variable: length of hospital stay (days). Survival analysis was performed using the Kaplan-Meier Method and the survival effect was estimated - Log Rank Test (Mantel-Cox) and Breslow Test (Generalized Wilcoxon). A significance level of 5% was adopted. Results: of the 109 mother/child pairs, 56 were part of the treatment and 53 were part of the control group. There was no association between oropharyngeal colostrum immunotherapy and length of stay for preterm newborns with very low birth weight in the general sample. However, after stratification, a shorter hospital stay (42 versus 51 days, HR= 1.78, CI95%=1.02-3.09, p=0.04) was demonstrated among premature infants with ≥28 gestational weeks undergoing oropharyngeal colostrum immunotherapy. Conclusions: we found an association between oropharyngeal colostrum immunotherapy and shorter median length of hospital stay in the subgroup of premature infants ≥ 28 weeks of gestational age, but we did not find significant differences in those

Abstract Objective Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction and by restricted and repetitive patterns of behavior. Some studies have shown that substances derived from Cannabis sativa improve the quality of life of children with ASD without causing serious adverse effects, thus providing an alternative therapeutic option. The objective of this study was to evaluate the efficacy and safety of a cannabis extract rich in cannabidiol (CBD) in children with ASD. Methods In this randomized, double-blind, placebo-controlled clinical trial, 60 children, aged from 5 to 11 years, were selected and divided into two groups: the treatment group, which received the CBD-rich cannabis extract, and the control group, which received the placebo. They both used their respective products for a period of 12 weeks. Statistical analysis was done by two-factor mixed analysis of variance (two-way ANOVA). Results Significant results were found for social interaction (F1,116 = 14.13, p = 0.0002), anxiety (F1,116 = 5.99, p = 0.016), psychomotor agitation (F1,116 = 9.22, p = 0.003), number of meals a day (F1,116 = 4.11, p = 0.04), and concentration (F1,48 = 6.75, p = 0.01), the last of which was only significant in mild ASD cases. Regarding safety, it was found that only three children in the treatment group (9.7%) had adverse effects, namely dizziness, insomnia, colic, and weight gain. Conclusion CBD-rich cannabis extract was found to improve one of the diagnostic criteria for ASD (social interaction), as well as features that often co-exist with ASD, and to have few serious adverse effects.

Objective: To assess the methodological quality and characteristics of systematic reviews (SRs) of interventional studies in orthodontics and assess how the certainty of the evidence is reported using the GRADE approach. Material and Methods: Six electronic databases were searched, followed by a hand search of the reference lists of eligible studies (PROSPERO #CRD42020180852). The required study design was randomized and nonrandomized studies of interventions published between January 2019 and May 2020. The Assessing the Methodological Quality of Systematic Reviews (AMSTAR 2) tool was used for the quality appraisal of the included SRs. Paired reviewers independently screened the studies, extracted data, and appraised the methodological quality. Results: The study included 46 SRs; 19.5% had moderate to high methodological quality, and the remaining had low to critically low methodological quality. Fifty-four percent of the reviews assessed the certainty of evidence using the GRADE approach, and 34.8% followed all GRADE criteria. Conclusion: Most reviews had a good judgment of the AMSTAR2 items, although some critical items contributed to decreased overall quality. Half of the reviews used the GRADE approach to assess the certainty of the evidence, and this approach should be included in future systematic reviews of interventions.

Objective: to analyze the effects of a Mindfulness-based intervention on nurse leaders’ emotional intelligence and resilience. Method: a pilot study of a randomized crossover clinical trial. The sample (n=32) was randomized into Group A (n=18) and Group B (n=14) and evaluated at the pre-test, post-test and follow-up moments. The outcomes were assessed using the Emotional Intelligence Measure, the Connor-Davidson Resilience Questionnaire and the Five Facet Mindfulness Questionnaire, and analyzed using Generalized Linear Mixed Models. Results: a total of 32 nurses with a mean age of 42.6 years old were evaluated. The analyses showed significant interactions between the effects of the group x moment factors on the Self-motivation (p=0.005), Sociability (p

BACKGROUND: The quality of reporting in the abstract section of scientific articles is one of the important aspects of good communication of trials. OBJECTIVES: We investigated abstracts of randomized clinical trials (RCTs) in the physical activity field according to adherence to the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts (primary outcome) and checked the recommendations of the selected journals regarding the contents and structure of the abstract. METHODS: This study is a descriptive, cross-sectional study of the Strengthening the Evidence in Exercise Sciences (SEES) Initiative. RCTs published in 9 exercise science journals and 2 general medicine journals during 2019 were eligible. Two researchers conducted study selection and, thereafter, assessment of the abstracts using a form comprising 16 items based on CONSORT for Abstracts. Also, extracted, in duplicate and independently, the journals’ recommendations for authors. RESULTS: 131 abstracts were eligible for evaluation. From items evaluated, those with the highest adherence were objectives or hypothesis (99%), conclusion (98%), and intervention (94%). The lowest reporting was observed in the number of participants analyzed (6%), allocation and randomization (1%), and funding (1%). Ten journals recommended the abstract structure, but only two mentioned the CONSORT for Abstracts. CONCLUSIONS: There is variable and suboptimal adherence to the CONSORT for Abstracts in trials in the physical activity field and poor recommendation of this instrument in journals selected. Therefore, we suggest editors, reviewers, and authors a greater adherence to guidelines, and to journal recommendations to improve the quality of reporting of abstracts in the physical activity field.

ABSTRACT Objective: To evaluate the effectiveness of cinnamon in reducing lipid levels in people with diabetes. Method: Randomized clinical trial of parallel groups, triple-blind, conducted in Basic Health Units in the state of Piauí in 2019. People with Type 2 Diabetes Mellitus, between 18 and 80 years old, using oral antidiabetics, were included, and divided into two groups. The experimental group tested 3g of cinnamon for 90 days. Results: 140 people participated in the study. From these, the experimental group (n= 71) showed a reduction in mean levels of total cholesterol (p= 0.316 | CI 95% -24.9-8.1), LDL (p= 0.024 | CI 95% -29.3 -2.1) and triglycerides (p= 0.969 | 95% CI -28.6-27.5), and increased HDL (p= 0.001 | 95% CI 4.2-10.2). Conclusion: The use of 3g of cinnamon per day, for 90 days, seems to help reduce LDL values and increase HDL levels in patients with diabetes.

That of COVID-19 has prompted the search for effective drugs that limit the spread of SARS-CoV-2. Several clinical trials have sought to evaluate the therapeutic use of Hydroxychloroquine (HCQ) against the infection caused by the virus. The objective of this article was to carry out a systematic review to evaluate the efficacy and safety of using HCQ, in studies with different settings, for the treatment of COVID-19. The method used was PRISMA, through the search for randomized clinical trials, published between 2020 and 2022, in journals indexed in the MEDLINE database, in English, resulting in 13 papers selected for analysis. Randomized multicenter clinical trials were reviewed, corresponding to 14,838 patients, whose age range varied between 32 and 65 years. The test used for the detection of SARS-Cov-2 was the gold standard RT-PCR. The studies presented up to 3 study arms, namely: B1- control group; B2- treatment with HCQ alone and B3- treatment with HCQ in association with other drugs. Of the 13 studies, only 1 showed a significant association with the use of hydroxychloroquine in the treatment of COVID-19, however this was for the worsening of the clinical picture. Thus, it is concluded that HCQ did not reveal a significant reduction in mortality. [ABSTRACT FROM AUTHOR]

Objectives: To re-evaluate a sample of older adults enrolled in a randomized controlled trial of lithium for amnestic mild cognitive impairment (MCI) after 11 to 15 years, re-assessing their current (or last available) global cognitive and functional state. Methods: We recalled all former participants of the Lithium-MCI trial conducted by our group between 2009 and 2012 to perform a single-blinded, cross-sectional evaluation of their global clinical state to compare the long-term outcome of those who received lithium vs. those who received placebo. Results: Of the original sample (n=61), we were able to reach 36 participants (59% of retention), of whom 22 had previously received lithium (61% of the recall sample) and 14 (39%) had received placebo. Since 30.5% of the recalled sample was deceased, psychometric data were collected only for 69.5% of the participants. We found statistically significant differences in current mean Mini Mental State Examination score according to previous treatment group (25.5 [SD, 5.3] vs. 18.3 [SD, 10.9], p = 0.04). The lithium group also had better performance in the phonemic Verbal Fluency Test than the control group (34.4 [SD, 14.4] vs. 11.6 [SD, 10.10], p < 0.001). Differences in these measures also had large effect sizes, as shown by Cohen’s d values of 0.92 and 1.78, respectively. Conclusion: This data set suggests that older adults with amnestic MCI who had been treated with lithium during a previous randomized controlled trial had a better long-term global cognitive outcome than those from a matched sample who did not receive the intervention.

Objective: To test the efficacy of smartphone-assisted online brief cognitive behavioral therapy (b-CBT) to treat maternal depression compared to online brief CBT plus an active control app. Methods: A randomized controlled trial was conducted. Assessments were performed at baseline (T0), midpoint (T1, week 4-5), post-treatment (T2, week 8), and follow-up (T3, 2-month postnatal follow-up) by blinded interviewers. The primary outcome was depression measured by the Edinburgh Postnatal Depression Scale (EPDS) at T2. We also assessed anxiety, stress, sleep quality, well-being, physical activity, treatment response, and offspring child behavior problems. Results: Eighty-one participants were randomized to the intervention (n=37) or active control (n=44) groups. Seventy-one participants completed the post-treatment assessment or reported primary outcome data. No differences were found between the intervention and active control groups regarding maternal depression or other mental health outcomes. Overall, we found large within-group effect sizes, with 80% of the total sample responding to treatment. Conclusions: Our data showed no difference between the groups, suggesting that adding apps to psychotherapy treatment may not enhance treatment effects on prenatal depression. A within-groups analysis showed that most participants with depression responded to treatment; however, future studies are needed to confirm whether this effect is related to factors other than the intervention.

Background: Self-perception about food consumption plays an important role in moving toward a healthy diet. Objective: To assess the effect of a nutritional intervention on the perception of fruit consumption in adolescents. Method: A community-based randomized trial was carried out. The intervention consisted of integrated actions of primary prevention (at school) and secondary prevention (at home), both encouraging the participants to adopt healthy eating habits through playful activities. The participants were classified as either "optimistic" or "non-optimistic" according to their reported fruit consumption and self-perception about the amount of fruit consumption. The intervention effect was tested using random-effects logistic regression. Results: The frequency of optimistic individuals at baseline was 19.1% and 18.5% in the control and intervention groups, and 17.5% and 17.6% at the end of the study (p = 0,743 for the group*time interaction and 0,802 when adjusted for race). The prevalence of optimism was higher in males, in participants who considered their overall diet quality very good or excellent, among those with the lowest frequency of soda and cookie consumption, and in participants who rarely reported sharing mealtime with their parents. Conclusion: The school-based intervention did not affect the change in perception regarding fruit intake. [ABSTRACT FROM AUTHOR]

Objective: To compare clinical and radiographical pulpectomy outcomes in primary teeth filled with different pastes. Material and Methods: The sample included thirty-eight teeth indicated for pulpectomy due to irreversible pulp inflammation or necrosis from thirty patients (2 to 9 years old). The first appointment comprised chemomechanical preparation (2.5% sodium hypochlorite), smear layer removal (6% citric acid), intracanal dressing and temporary restoration. Seven days later, teeth were randomly assigned to filling with iodoform (IP) or calcium hydroxide with zinc oxide (CHZO) based pastes and temporarily restored. Final restoration (composite resin) occurred at the 3rd appointment. Data from baseline, 6 and 12 months were analysed using descriptive and inferential statistics (p≤0.05). Results: The overall frequency of success was 63.6% (n=21), with no significant difference between groups (IP=62.5% n=10; CHZO=64.7% n=11, p=0.59). Multiradicular teeth, overfilled canals and teeth whose coronal restoration have been lost were significantly associated with failure (p=0.01, p=0.04 and p

Objective: To evaluate the influence of non-invasive treatment associated with the use of infiltrating resin for managing caries lesions in primary teeth. Material and Methods: A systematic review was performed by selecting articles from 6 online databases, using a search algorithm and eligibility criteria for data extraction and data synthesis for the papers included. Clinical trials involving primary teeth with incipient caries lesions (1/2 of the enamel or 1/3 of the outer dentin) were included, presenting full text and answering the study's guiding question. This study used the RoB 2 tool for the risk of bias assessment and GRADE for certainty of evidence. Random effects meta-analyses were implemented, and lesion progression treatment effects were estimated through relative risk (RR) and associated 95% confidence intervals. Results: A total of 440 studies were found. After analyzing the inclusion criteria and removal of duplicates, eight studies were analyzed for quality evidence. Five of the eight studies included in this review contributed to the meta-analysis, all with some reflections regarding the risk of bias. Overall, the results of the meta-analysis showed that non-invasive treatment, when associated with the use of infiltrating resins, significantly reduced the risk of caries progression in relation to the treatment without this addition for follow-up periods ranging from 12 months to 2 years (RR 0.51 [0.40-0.65]). Conclusion: There is moderate certainty of evidence that the use of infiltrating resins associated with non-invasive treatments decreases the risk of caries progression in primary teeth with incipient caries lesions (1/2 of the enamel or 1/3 of the dentin outer) when combined with non-invasive control methods alone.

ABSTRACT Introduction: Fixed orthodontic retainers are very important for treatment stability; however, adverse effects on the health of periodontium can be caused as a result of deposition of plaque and calculus. Objectives: To compare and determine the effects of two mandibular fixed lingual retainers on the periodontal status, and to test the null hypothesis that there would be no significant difference on the periodontium health between the patients using fiber-reinforced composite (FRC) or multistranded wire (MSW) fixed retainers. Methods: A total of 60 subjects were recruited, out of which 6 were excluded and 2 dropped out during the study. Hence, 52 subjects with mean age of 21.5 ± 3.6 years were included in the study. The sample was composed by 8 males (15.4%) and 44 females (84.6%). The participants were randomly divided into two groups: Group 1 received fiber-reinforced composite retainer, while Group 2 received multistranded wire retainer. After insertion, plaque index, calculus index, gingival index and bleeding on probing were compared, after three months (T1), six months (T2), nine months (T3) and twelve months (T4), using Mann-Whitney test with p-value ≤ 0.05 as significant. Results: It could be seen that the health of periodontium deteriorated with the passage of time from T1 to T4 in both group of retainers. However, no statistically significant differences were found between the two groups (p> 0.05). Conclusion: The results of the study indicate that there was no significant difference on the health of periodontium between the patients with FRC and MSW fixed retainers, hence, the null hypothesis was accepted.

Copyright of Revista Ciência & Saúde Coletiva is the property of Associacao Brasileira de Pos-Graduacao em Saude Coletiva and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective: To identify Fiocruz's performance in clinical studies related to Covid-19. Analyze the different terminologies used to refer to Fiocruz participation. Map the region of these studies. Measure the number of studies approved on clinical study registration platforms and regulatory ethical bases. Analyze the methodological characteristics and good practices of the interventional study protocols. Methods: We reviewed databases of Brazilian National Research Ethics Committee, databases of Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA), Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), US Food and Drug Administration (FDA) and Brazilian National Institute of Industrial Property (Instituto Nacional de Propriedade Industrial-INPI). Results: 53 clinical studies on Covid-19 were found with the participation of Fiocruz in 39 of them as a proponent institution. Among the 53 studies, 19 are on registration platforms. Of the registered interventional studies, 5 are for prevention and 9 for treatment. The intervention most frequently evaluated in these studies was chloroquine/hydroxychloroquine. There was also a greater concentration of clinical studies in the southeastern region, with a total of 37 studies. Conclusion: Some limitations in the methodological design were analyzed, which may affect the scope of the studies. It is expected that the data obtained will be used to guide future clinical studies on Covid-19 with Fiocruz participation. [ABSTRACT FROM AUTHOR]

Objective: To characterize the intervention studies registered by nurses in the Brazilian Registry of Clinical Trials. Methods: Descriptive study, with quantitative approach, carried out through virtual access to the Brazilian Registry of Clinical Trials, to search for the studies registered on the platform. After reading the 3350 abstracts available, the 320 registered by nurses were selected to make up the sample. Descriptive analysis was performed in the software R. Results: Studies registered between 2010 and 2019 were found, of which 49.7% were in the Southeast region, 49.3% registered by doctors, 46.3% affiliated to federal universities. The most studied nursing area (18.8%) it was adult health, 72.9% had two arms, 53.1% with completed recruitment, 50.3% performed blinding and the most studied type of interventions (21.9%) was the educational. Conclusion: Most intervention studies registered by nurses in the Brazilian Registry of Clinical Trials tested educational interventions in adults, blinded and randomized. [ABSTRACT FROM AUTHOR]

Objective: To analyze the effectiveness of the low-potency laser, local and systemic, for the healing and reduction of pain caused by nipple trauma. Methods: Clinical, randomized and controlled trial carried out with 54 lactating women assisted in a Human Milk Bank, from December 2017 to June 2018. The lactating women, which totaled 101 lesions, received guidance on the clinical management of their breasts and breasts designated in: Control Group (CG), Local Laser Group (GLL), which received laser directly on the injured nipple, and Intravascular Blood Laser Irradiation Group (GILIB), which received systemic laser therapy. Data were analyzed using the SPSS to assess the homogeneity of the groups (Kruskal-Wallis) and the linear regression to identify the effect of the intervention on the size of breast lesions and the intensity of pain. Results: The three analysis groups were homogeneous before the experiment (p=0.191). After the intervention, the healing of the lesions in the three groups was significantly higher in GLL and GILIB (p<0.050). As for the pain, there is a reduction of up to 4.0 points in GLL and GILIB (p=0.002). Conclusion: The administration of local and systemic laser therapy was more effective for the cure of nipple trauma and pain reduction, in comparison with the control group. [ABSTRACT FROM AUTHOR]

Copyright of Revista Eletrônica de Enfermagem is the property of Revista Eletronica de Enfermagem and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract Objective To compare the techniques for the osteosynthesis of intertrochanteric fractures with dynamic hip screws (DHSs) through the Hardinge and minimally-invasive access routes of the hip, evaluating the operative time, the degree of pain in the immediate postoperative period, the hematimetric loss, and the functional aspects of active mobility. Methods A randomized, double-blinded clinical trial in which 66 patients with intertrochanteric fractures were submitted to osteosynthesis by DHS. The patients were divided into a test group, submitted to the minimally-invasive access, and a control group, in whom the surgery was performed through the Hardinge route. Results Patients submitted to the minimally-invasive treatment presented a lower degree of postoperative pain compared to the group treated by the Hardinge lateral route (p< 0.001), as well as lower hematimetric loss (p< 0.001), shorter operative time (p< 0.001), and improvement in immediate postoperative active mobility tests (p

Abstract Objective: to evaluate the effect of nursing home care interventions on the quality of life in family caregivers of aged stroke survivors. Method: a Randomized Clinical Trial, blinded for outcome evaluation. Forty-eighty family caregivers of aged stroke survivors participated in the study. The Intervention Group received three home visits by nurses one month after hospital discharge to provide stroke-related education (i.e., how to access health services and perform care activities) and emotional support. The Control Group received the usual guidance from the health services. Quality of life was assessed using the World Health Organization Quality of Life Assessment (WHOQOL-BREF) instrument and the Old Module(WHOQOL-OLD) 1 week, 2 months, and 1 year after discharge. Results: the caregivers were mainly women, children, or spouses. The caregivers in the Intervention Group and Control Group did not significantly differ in terms of their Overall Quality of Life at baseline. There was no interaction effect between group allocation and Overall Quality of Life(p=0.625) over time. However, there was an interaction effect for Social Relations(p=0.019) and Autonomy (p=0.004). Conclusion: the intervention exerted a statistically significant effect on the quality of life of family caregivers with respect to social relationships and autonomy. Trial registration: NCT02807012.

ABSTRACT Objective: Heterotopic ossification is defined as the formation of trabecular bone in soft tissues. It is a common complication after surgical treatment of acetabular fractures. However, its prophylaxis and treatment are still controversial. The objective of this research is to evaluate the effectiveness of actions to prevent the development of heterotopic ossification after surgical correction of acetabular fractures. Methods: A systematic review was carried out with research in the databases PubMed/MEDLINE, Embase, LILACS and Cochrane until August 4, 2020, without restrictions on language and year of publication. Only randomized clinical studies carried out in humans without restrictions based on the dosage of treatments, use and duration of prophylaxis were included in this review. Results: Two studies compared the use of radiotherapy and indomethacin and three compared the use of indomethacin with a placebo or non-indomethacin group. The meta-analysis calculations did not indicate statistical differences between radiotherapy versus indomethacin (RR 1.45, IC 95% 0.97 to 2.17, p = 0,55) and indomethacin versus placebo or not indomethacin (RR 0.85, IC 95% 0.68 to 1.06, p = 0,59). Conclusion: There is insufficient evidence to affirm that the use of radiotherapy or indomethacin are effective to prevent the formation of heterotopic ossification after surgery for fractures of the acetabulum. In addition, the number of complications was higher in the indomethacin group when compared to placebo or no intervention. Level of Evidence I, Systematic Review.

Objective: To compare the complications between the Peripherally Inserted Central Catheter with length adjustment with cut and without cut. Method: Randomized controlled trial. Composed the sample 46 neonates admitted to a Neonatal Intensive Care Unit service in Paraná, Brazil, between April and July 2021, with catheter indication. Participants were electronically randomized and divided into a control group, whose catheter length was adjusted by cutting it, and an experimental group, whose catheter was kept uncut. Data were analyzed by Mann-Whitney test and Fisher's test. Results: The mean length of catheter stay was ten days in both groups (p=0.79). No relevant difference was identified regarding complications, such as infiltration, obstruction, and infection. Conclusion: Catheter cutting for length adjustment does not interfere in the complications presented. REBEC Register: RBR-2w4dpg5.

Objective: to evaluate effectiveness of realistic clinical simulation for teaching pulmonary physical examination to undergraduate nursing students. Methods: experimental study of pre-test and post-test type applied to randomized intervention and control groups. The sample consisted of 30 students, randomly divided. The analysis was performed using descriptive and inferential statistics, through Kolmogorov-Smirnov test and t-test for independent samples, considering statistical significance p≤0.05. A satisfaction scale validated with the intervention group was applied. Results: we identified increased correct answers in post-test in the intervention group, which was submitted to realistic simulation. In this group, the mean number of errors varied from 4.87 in the pre-test to 2.13 in the post-test. In the control group, students either decreased or maintained the number of correct answers in the post-test, and mean errors increased, from 3.87 in the pre-test to 4.0 in post-test. The difference in correct answers between intervention and control groups was significant (p=0.000). Conclusion: from realistic simulation, students obtained a lower average error rate on post-test. Contributions to practice: results of this research favor the curricular insertion of simulation for teaching pulmonary physical examination in undergraduate nursing.

During the COVID-19 pandemic, several late-onset impairments have been observed, affecting the health and functionality of those involved. On the other hand, lower SARS-CoV-2 infection rates and severity of symptoms were observed in high-altitude cities. In this sense, the AEROBICOVID project was developed with the hypothesis that exercise would be an important opportunity for health improvement and that hypoxia would promote additional benefits in the recovery process. The cohort was about 84 participants with approximately 30 days since the COVID-19 symptoms recovery, 25 in the control group, and 59 divided into three moderate physical training groups. The project had good results in teaching, research, and extension, but also faced difficulties in operationalization. This experience is the basis for future proposals through an extension project at the University of São Paulo and in a Family Health Unit, besides a research project that will develop a new low-cost hypoxia technology.

ABSTRACT Objective: to assess the effectiveness of a cognitive-behavioral program to control lower urinary tract symptoms after radical prostatectomy. Methods: a randomized clinical trial study, with 41 participants randomized into intervention (n=20) and control (n=21), for three months. The intervention group received the cognitive-behavioral program, while the control group received routine guidance from the service. Outcome variables were urinary incontinence intensity and lower urinary tract symptoms, assessed by the Pad-Test and Urinary Incontinence Scale of Radical Prostatectomy and King’s Health Questionnaire. Results: at the end of the study, the intervention group had a lower urinary incontinence intensity (p≤0.001), and there were less chances of presenting changes in urinary frequency (p≤0.001), urinary urgency (p≤0.001), nocturia (p=0.005), stress urinary incontinence (p≤0.001) and urge incontinence (p≤0.045). Conclusion: the cognitive-behavioral program was effective in reducing lower urinary tract symptoms after radical prostatectomy. Brazilian Clinical Trial Registry: RBR-3sstqg.

ABSTRACT Objective To evaluate the clinical, obstetric, maternal and perinatal effects of the use of flower essences in labor, against factors that enhance it. Method Clinical trial, randomized, controlled, in 164 parturients divided into two groups, flower essences and placebo, respectively, evaluated before and after the intervention. Carried out in a vaginal delivery center, in the city of São Paulo, from May to October 2018. Data were analyzed using descriptive statistics, Student's t test, bilateral hypothesis, negative and positive observed critical t, Pearson's chi-square, exact test. Fisher. Results It was observed in the Experimental Group, moderate increase in systolic blood pressure (p=0.046), frequency (p=0.055) and intensity of contractions (p=0.031), as well as a reduction in time to birth (194 minutes), higher number of vaginal deliveries (p=0.038) and better pattern of fetal vitality. Conclusion There was evidence of a positive action of the Floral Essence on the potentiating factors of labor, being effective in maternal clinical and obstetrical repercussions, as well as perinatal ones.

Abstract Objective To evaluate the number of patients with early-stage breast cancer who could benefit from the omission of axillary surgery following the application of the Alliance for Clinical Trials in Oncology (ACOSOG) Z0011 trial criteria. Methods A retrospective cohort study conducted in the Hospital da Mulher da Universidade Estadual de Campinas. The study population included 384 women diagnosed with early-stage invasive breast cancer, clinically negative axilla, treated with breast-conserving surgery and sentinel lymph node biopsy, radiation therapy, chemotherapy and/or endocrine therapy, from January 2005 to December 2010. The ACOSOG Z0011 trial criteria were applied to this population and a statistical analysis was performed to make a comparison between populations. Results A total of 384 patients underwent breast-conserving surgery and sentinel lymph node biopsy. Of the total number of patients, 86 women underwent axillary lymph node dissection for metastatic sentinel lymph nodes (SNLs). One patient underwent axillary node dissection due to a suspicious SLN intraoperatively, thus, she was excluded fromthe study. Among these patients, 82/86 (95.3%) had one to two involved sentinel lymph nodes andmet the criteria for the ACOSOG Z0011 trial with the omission of axillary lymph node dissection. Among the 82 eligible women, there were only 13 cases (15.9%) of lymphovascular invasion and 62 cases (75.6%) of tumors measuring up to 2 cm in diameter (T1). Conclusion The ACOSOG Z0011 trial criteria can be applied to a select group of SLNpositive patients, reducing the costs and morbidities of breast cancer surgery.

Copyright of Revista Bioetica is the property of Conselho Federal de Medicina and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract Objectives: to evaluate the impact of a health program performed in a school setting on the blood pressure levels of schoolchildren in the public school system in Vitória/ES-Brazil. Methods: a randomized community trial was performed with 237 schoolchildren (6 to 12 years) from two public schools, randomly defined as the intervention and control school. Participants of the intervention group attended 11 education sessions over 4 months (July to October 2014). To test for differences between groups, the chi-square (categorical variables), and the paired t test or Wilcoxon (continuous variables) was used. The rate of variation of systolic blood pressure (SBP) and diastolic blood pressure (DBP) throughout the follow-up, according to allocation group, was evaluated using linear generalized models for time-repeated measures. Results: there was a reduction in the means of SBP (0.5 mmHg) and DBP (0.6 mmHg) in the intervention group and an increase in the control group, with a significant difference in the BP variation between groups over the follow-up period (p

Copyright of Cogitare Enfermagem is the property of Cogitare Enfermagem and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Nursing UFPE / Revista de Enfermagem UFPE is the property of Revista de Enfermagem UFPE and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not necessarily shorten the path to find safe and efficacious interventions for COVID-19. We analyze the trials for COVID-19 treatment and prevention that are registered from LAC countries in the International Clinical Trials Registry Platform, and identify a trend towards small repetitive non-rigorous studies that duplicate efforts and drain limited resources without producing meaningful conclusions on the safety and efficacy of the interventions being tested. We further assess the challenges to conducting scientifically sound and socially valuable research in the LAC region in order to inform recommendations to encourage clinical trials that are most likely to produce robust evidence during the pandemic.

Objective: This randomized clinical trial evaluated the behavior of restorations with flowable bulk-fill resin composite in posterior teeth three years after the restorative treatment. Methods: Seventeen patients (12 women, 5 men, age 23-59) were selected to have at least two failing amalgam or resin restorations replaced and/or to have a carious lesion restored. The cavities were randomly allocated to receive either the flowable bulk-fill composite Surefil SDR Flow occlusally covered with the conventional nano-hybrid composite Esthet-X HD (bulk and body technique) or filled exclusively with Esthet-X HD placed in 2 mm increments (incremental technique). A two-step etch-and-rinse adhesive was applied in all cavities. Thirty-four Class I or II restorations were performed in posterior teeth (n=17) during baseline. After 03 years, modified USPHS and FDI criteria were used to evaluate the restorations. Data were subjected to Mann-Whitney statistical analysis (p0.05). No restoration failures were observed over time. Conclusion: After 03 years of clinical service, all restorations using a flowable bulk-fill composite in posterior teeth showed an acceptable performance. Clinical Significance: The overall quality of posterior restorations made with the bulk and body technique was similar to that of restorations made with a nano-hybrid composite incrementally placed. *This study was registered in the National Clinical Trials Registry (REBEC – RBR-2g9st7).

ABSTRACT A systematic review of the literature was performed in order to organize, evaluate, and select evidences available about the safety and efficacy of minimally invasive percutaneous arthrodesis with percutaneous pedicle screws in the treatment of patients with degenerative disc disease (and other spinal pathologies) as compared to conventional arthrodesis. PubMed, EMBASE and Cochrane Library databases were consulted to locate clinical trials and case reports/case series published in English between 2014 and 2019. After selection according to the inclusion/exclusion criteria, 21 of the 197 articles identified were chosen for a complete reading and used for the present review. Although the level of evidence of most of the studies included made the demonstration of efficacy and superiority among the surgical techniques reviewed difficult, the findings related to the minimally invasive procedure indicate a safe and reliable approach for the treatment of lumbar diseases. Level of evidence II; Systematic review of literature.

Abstract Background and objectives: The measurement of hemoglobin concentration (Hb) by co-oximetry is an innovative technique that offers efficiency and agility in the processing of information regarding the measurement of Hb obtained through continuous, non-invasive and rapid monitoring. Because of this attribute, it avoids unnecessary exposures of the patient to invasive procedures by allowing a reduction in the number of blood samples for evaluation and other unnecessary therapies. It also helps to make decisions about the need for transfusion and how to handle it. The objective of this study is to compare the performance offered to obtain Hb values between the Masimo Corporation (Irvine, CA, USA) instrument and the standard gold tool (laboratory examination). Contents: The study corresponds to a systematic review followed by meta-analysis, which included fully registered full-text clinical trials published from 1990 to 2018. PubMed, Cochrane, Medline, Embase and Web of Science databases were investigated. The mean overall difference found between the non-invasive and invasive methods of hemoglobin monitoring was 0.23 (95% CI -0.16, 0.62), that is, it did not present statistical significance (p = 0.250). The results of the analysis of heterogeneity within and between the studies indicated high levels of inconsistency (Q = 461.63, p < 0.0001, I2 = 98%), method for Hb values. Conclusions: Although the mean difference between noninvasive measurements of Hb and the gold standard method is small, the co-oximeter can be used as a non-invasive “trend” monitor in detecting unexpected responses at Hb levels.

This randomized controlled clinical trial evaluated the effectiveness of using indirect pulp protection with calcium hydroxide liner or universal adhesive over a period of 6 months in deep caries on permanent teeth after selective removal to soft dentin. The sample consisted of 68 patients with 55 molars and 21 premolars with deep caries lesion (with radiographic involvement ≥50% dentin deep caries), (median age 27 [distribution 7-54 years]), with signs of pulp vitality (positive response to cold test, absence of spontaneous pain, negative sensitivity to percussion tests, absence of radiographic imaging suggestive of periapical lesion) and absence of cuspid loss. After selective removal to soft dentin, the test group received a universal adhesive (n=38), whereas the control group indirect pulp protection with Calcium hydroxide (n=38). All teeth were restored with composite resin. The successful outcome for pulp vitality was assessed after six months. The results were submitted to the Kaplan-Meier survival analysis and the Log Rank test. The baseline variables were analyzed for their distribution in the two treatment groups by ᵪ2 test and showed a similarly distributed between groups. Success rates to pulp maintenance vitality were 95.5% for the control group and 96.7% for the test group (P=0,986). Two cases of failure were recorded, one pulp necrosis (control group) and one pulpitis (test group). There is no difference between the use of calcium hydroxide or only universal adhesive in indirect pulp protection after selective removal to soft dentine followed by composite restoration at six months of follow-up, showing a high rate of success for both treatments.

ABSTRACT Objective: Dupuytren’s disease is a genetic disorder related to the proliferation of myofibroblasts. The pluripotent property of stem cells present in adipose tissue inhibits myofibroblast proliferation. Our study sought to evaluate the effect of stem cell-rich fat grafts in patients that underwent limited fasciectomy. Methods: We studied 45 patients, in a single-blind, prospective, randomized clinical trial. All patients underwent limited fasciectomy. In one group, fat graft was injected. Results: The total passive extension deficit results did not exhibit a significant difference. Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up. Conclusion: Fat grafting associated with limited fasciectomy promotes worse functional results compared to conventional limited fasciectomy in the short term. However, long-term results and recurrence rates should be further assessed. Level of Evidence II, Prospective comparative study.

The objective was to compare the effects of Yoga Thai massage and conventional stretching on pain, functionality, muscle flexibility, mobility and quality of life in women with low back pain. We performed a controlled clinical trial, randomized and blind in which women with low back pain and aged between 20 and 40 years participated. We used Numerical Visual Scale for pain intensity, Owestry questionnaire for functionality and SF36 questionnaire for quality of life. Muscle flexibility and mobility were verified with the following tests: muscle length of the hamstrings and popliteal angle, Wells bench, 3rd finger on the ground, Thomas, Stibor and modified Schober. Twenty-one participants were randomized into three groups: Yoga Thai Group -- YTG (4 Yoga Thai massage sessions); Stretching Group -- SG (4 sessions of static active stretching) and Control Group -- CG (maintenance of usual activities). The YTG improved 65.9% intensity of pain, 17.7% flexibility of the posterior chain muscle and 56% "Limitation by physical aspects" and 85% "Pain", aspects of quality of life. The GA increased 15.5% muscle length of the hamstrings, 36.9% popliteal angle and 16.6% flexibility of the spine. It also improved the quality of life (300% "Limitation due to Physical Aspects", 58.2% "Social Aspects" and 57.5% "Mental Health"). We found no differences between groups. Yoga Thai massage was effective in improving pain and flexibility, contributing to quality of life. Stretching increased flexibility, also contributing to the quality of life of women with low back pain. [ABSTRACT FROM AUTHOR]

ABSTRACT Objective: To verify if participation in educational workshops about bonding with the fetus influences the adoption of practices of interaction with the baby by pregnant women. Method: Randomized clinical trial conducted in a health clinic. The experimental group participated in educational workshops designed for the pregnant couple and the control group received usual care. The practices of interaction with the fetus were evaluated before and after the intervention. Results: 19 pregnant women participated in the study. There was a positive correlation between higher gestational age and the interaction with the fetus (p = 0.016), and between younger mothers and the practice of touching or poking the baby (p = 0.019). There was an increase in the interaction with the fetus in the control and experimental groups (p= 0.024). Conclusion: Educational workshops are strategies for sharing knowledge about fetuses' sensory skills and to foster bonding and child development since pregnancy.

ABSTRACT Objectives To determine the efficacy of a multicomponent nursing program to prevent delirium in critically ill patients. Methods Parallel controlled randomized clinical trial to prevent delirium in 81 critically ill patients: 41 in the control group and 40 in the intervention group (intervention: spatial and temporal guidance, visual stimulus, auditive stimulus, and family support). Participants were recruited from September 2017 to March 2018 in the university hospital Los Comuneros, Bucaramanga, Colombia. Clinical Trials record NCT03215745. Results The incidence of delirium was 5% in the intervention group and 24% in the control group. The relative risk was 0.20 (95% CI 0.05 to 0.88). The absolute risk reduction was 19.39% (95% CI 4.61 to 34.17) and the number needed to treat was 5 (95 CI % 3 to 26%). Conclusion The multicomponent nursing program is efficient to prevent delirium in critically ill patients.

ABSTRACT Objective: To analyze the effects of an educational intervention via telephone on maternal breastfeeding self-efficacy. Method: Randomized controlled clinical trial including 240 puerperae from a secondary care hospital randomized into two groups: control and intervention. The educational intervention took place at seven, 30, 90, and 150 days postpartum and centered on self-efficacy and motivational interviewing principles. Self-efficacy was measured by the Breastfeeding Self-Efficacy Scale – Short Form. The data followed the abnormal distribution, so non-parametric tests were used. Results: The intervention group obtained higher median breastfeeding self-efficacy scores across the three outcome measures when compared to the control group (p < 0,001). Furthermore, the intervention group showed increased self-efficacy scores at all monitoring moments, which shows that the educational intervention was able to raise and maintain women’s confidence in breastfeeding their child over time. Conclusion: The use of a telephone-based intervention focused on self-efficacy principles and delivered by trained nurses effectively promoted maternal confidence in breastfeeding. Brazilian Clinical Trial Registry: RBR-7m7vc8.

ABSTRACT Objectives: to assess the effects of floral therapy in the face of factors that boost pain in the parturition process and its results in the duration of labor. Methods: this is a randomized, controlled and triple-blind clinical trial. We selected 164 pregnant women with gestational age ≥37 weeks, cervical dilation ≥4 cm, randomly divided into floral therapy and placebo group. Results: the Five Flower floral essence proved to be effective, considering the factors that boost pain in labor. Experimental Group did not show an increase in contractions, unlike Control Group, which presented an increase of one contraction for mothers in active phase and amniorrhexis. The Five Flower essence proved to be effective in reducing labor time by 1:30h from the beginning of the intervention at birth. Conclusions: floral therapy proved to be effective in pain management, reflecting positively in its brevity, qualifying its outcome.

ABSTRACT OBJECTIVE: To verify the effectiveness of screening for tuberculosis (TB) on all-cause mortality and tuberculosis cases in newly diagnosed HIV-infected patients through a clinical algorithm based on recommendations of the World Health Organization. METHODS: From March 2014 to April 2016, a pragmatic randomized clinical trial was conducted with newly diagnosed and TB-free HIV-infected adults undergoing antiretroviral therapy for up to one month at a major tertiary hospital for HIV in the state of Pernambuco, Brazil. Participants were randomized into intervention and control groups using an automatically-generated random list, and followed-up for at least 6 months. The intervention group was screened for TB at hospital admission and at every follow-up visit through a series of questions addressing TB-related symptoms (cough, fever, night sweating, and weight loss). Patients presenting with any of these symptoms were referred to a pulmonologist and underwent sputum smear microscopy, sputum culture, and rapid molecular testing (GeneXpert). When at least one test result came back positive, TB treatment was initiated. In turn, if patients tested negative but presented with severe clinal symptoms, TB preventive treatment was initiated. Screening for TB was not performed systematically in the control group. The primary outcome assessed in this study was death from all causes, and secondary outcomes included sensitivity and specificity of this screening test, as well as its detection time. RESULTS: This study evaluated 581 patients, 377 in the intervention group (64.9%) and 204 in the control group (35.1%). In total, 36 patients died during the follow-up period. Of these, 26 (6.9%) were from the intervention group, reaching a cumulative mortality coefficient of 69 per 1,000 inhabitants, and 10 (4.9%) from the control group (p = 0.341), with a cumulative mortality coefficient of 49 per 1,000 inhabitants (p = 0.341).

Introduction: To estimate the effectiveness of two physical activity programs on NAFLD.Methods: Participants come from a survey conducted in southern Italy. Subjects with moderate or severe NAFLD were invited to participate. After giving informed consent, they completed a questionnaire, underwent ultrasonography and anthropometric measurements. Then they were randomized an Aerobic or a Combined Exercise program and followed up for six months. The first group followed a program of moderate aerobic activity lasting 30 minutes, 5 days per week. The second group did aerobic training with the addition of muscle training involving the large muscle groups, stimulating them to make more intense efforts, for a duration of 60 minutes, at least, 3 days a week. Compliance with the programs was measured. A mixed linear model was applied to the data.Results: Compliance with Aerobic Exercise was homogeneous and increased over time. Combined Program compliance was equal to 100%. There was no significant difference in the NAFLD mean score by treatment at baseline and after six months. However, there was a significant reduction in the NAFLD mean score for treatments after six months. The NAFLD measured score was reduced by 22% in the Aerobic treatment group when confronted with the other program. In the Combined program, after 6 months, results showed to be less effective than the Aerobic Exercise in reducing the NAFLD score.Conclusions: An aerobic exercise program is a realistic intervention which could be included as a part of primary prevention of several chronic diseases.

ABSTRACT OBJECTIVE To analyze the effect of matrix support on health for older adults in primary care according to the dimensions of frailty measured with the Clinical-Functional Vulnerability Index-20 (IVCF-20). METHODS This is a randomized controlled community trial, developed in the Northern Minas Gerais state, Brazil, in 2018. Initially, the stratification of clinical and functional vulnerability of older adults supported by six Family Health Strategy teams occurred with the IVCF-20. Subsequently, three teams were drawn to receive matrix support for six months, and the others for control. In this intervention, face-to-face educational activities were developed for health teams. Descriptive statistics were performed, followed by bivariate analysis by Pearson’s chi-square test, to compare the variables of the IVCF-20 between the two moments (before and after the intervention), with a 5% significance level. Relative risks and respective 95% confidence intervals (95%CI) were estimated. RESULTS The groups were similar before intervention, and the effect of matrix actions was positive for most dimensions measured by IVCF-20 (instrumental daily living activity, cognition, mood, mobility, communication, and multiple comorbidities). At the end of the research, the percentage of frailty in the group assisted by professionals participating in matrix support was lower than that of the control group. CONCLUSIONS Matrix support actions, such as pedagogical attribution and horizontal care for health teams, have the potential to contribute to the articulation of models of care for older adults. REBEC registro BR-7b9xff