Brazilian Clinical Trials Research Articles

Interest, uptake, and feasibility trial of a real-life digital health intervention to improve lifestyle in Brazil.

Promoting healthy lifestyle behaviors is essential for preventing and managing chronic and mental health conditions. This study aims to present a digital health platform accessible via PC or smartphone, VIVA!, designed to foster lifestyle change among the Brazilian population. It evaluates interest, uptake, acceptability, usability, adherence, and retention over 12 weeks. A fully online feasibility trial was conducted from April to December 2023. Participants were adults who lived in Rio de Janeiro and reported using the Brazilian Public Health System. Interest in VIVA! and uptake were assessed via recruitment metrics. Acceptability and usability were measured using the Mobile App Rating Scale (MARS). Adherence was calculated as the percentage of completed challenges over 12 weeks, and retention was tracked at 4, 8, and 12 weeks. Of 3812 individuals reached, 27.2% expressed interest in the app, with an uptake rate of 65.4%. A total of 401 participants were enrolled, predominantly women (73.3%) with higher education (61.6%). MARS acceptability scores were 2.9 for quality and 3.5 for specificity. Usability scores averaged around 3, with aesthetics rated the highest. Retention at 12 weeks was 4.5%, and the average adherence rate was 11.2%. The VIVA! attracted women and highly-educated individuals, but its effectiveness was constrained by high attrition. These findings highlight key challenges in DHI implementation, including the need for robust outreach, iterative improvements, and strategies to sustain engagement. Addressing digital access, literacy inequities, and strengthening regulations are critical for the future success and equity of DHIs in public health systems. The trial was registered at the Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos -REBEC)-number RBR-2ssyb6q.

Clozapine for Treatment-Resistant Disruptive Behaviors in Youths With Autism Spectrum Disorder Aged 10-17 Years: Protocol for an Open-Label Trial.

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition emerging in early childhood, characterized by core features such as sociocommunicative deficits and repetitive, rigid behaviors, interests, and activities. In addition to these, disruptive behaviors (DB), including aggression, self-injury, and severe tantrums, are frequently observed in pediatric patients with ASD. The atypical antipsychotics risperidone and aripiprazole, currently the only Food and Drug Administration-approved treatments for severe DB in patients with ASD, often encounter therapeutic failure or intolerance. Given this, exploring pharmacological alternatives for more effective management of DB associated with ASD is essential. Clozapine, noted for its unique antiaggressive effects in schizophrenia and in various treatment-resistant neuropsychiatric disorders, independent from its antipsychotic efficacy, remains underexplored in youths with ASD facing severe and persistent DB. This study aimed to evaluate the efficacy, tolerability, and safety of clozapine for treatment-resistant DB in youths with ASD. This is a prospective, single-center, noncontrolled, open-label trial. After a cross-titration phase, 31 patients with ASD aged 10-17 years and with treatment-resistant DB received a flexible dosage regimen of clozapine (up to 600 mg/day) for 12 weeks. Standardized instruments were applied before, during, and after the treatment, and rigorous clinical monitoring was performed weekly. The primary outcome was assessed using the Irritability Subscale of the Aberrant Behavior Checklist. Other efficacy measures include the Clinical Global Impression Severity and Improvement, the Swanson, Nolan, and Pelham questionnaire-IV, the Childhood Autism Rating Scale, and the Vineland Adaptive Behavior Scale. Safety and tolerability measures comprised adverse events, vital signs, electrocardiography, laboratory tests, physical measurements, and extrapyramidal symptoms with the Simpsons-Angus Scale. Statistical analysis will include chi-square tests with Monte Carlo simulation for categorical variables, paired t tests or Wilcoxon tests for continuous variables, and multivariate linear mixed models to evaluate the primary outcome, adjusting for confounders. Recruitment commenced in February 2023. Data collection was concluded by April 2024, with analysis ongoing. This article presents the protocol of the initially planned study to provide a detailed methodological description. The results of this trial will be published in a future paper. The urgent need for effective pharmacological therapies in mitigating treatment-resistant DB in pediatric patients with ASD underscores the importance of this research. Our study represents the first open-label trial to explore the anti-aggressive effects of clozapine in this specific demographic, marking a pioneering step in clinical investigation. Adopting a pragmatic approach, this trial protocol aims to mirror real-world clinical settings, thereby enhancing the applicability and relevance of our findings. The preliminary nature of future results from this research has the potential to pave the way for more robust studies and emphasize the need for continued innovation in ASD treatment. Brazilian Clinical Trials Registry RBR-54j3726; https://ensaiosclinicos.gov.br/rg/RBR-54j3726. DERR1-10.2196/58031.

Reduction of norepinephrine versus vasopressin in the stabilization phase of septic shock: RENOVA clinical trial.

Evaluate the incidence of hypotension during the weaning phase of vasopressors. A single-center, open-label randomized clinical trial between May and December 2022. a tertiary care academic medical center. 91 adult patients over 18 years of age with septic shock (according to Sepsis-3). Patients were divided into two groups: initial reduction of norepinephrine or initial reduction of vasopressin. The primary outcome was the incidence of hypotension within the first 24 h after reducing vasopressors. Additionally, the clinical impact of this hypotension was assessed through mortality, length of hospital stay, duration of vasopressor use, incidence of arrhythmias, and prevalence of hemodialysis. Out of a total of 91 patients, 78 were included in the analysis: 39 in the norepinephrine group and 39 in the vasopressin group. Despite a numerically significant difference in the incidence of hypotension between the groups (norepinephrine 43.6%, vasopressin 25.6%), there was no statistical difference (p = 0.153, relative risk = 1.7, 95% confidence interval: 0.9-3.2). In this sample, vasopressin withdrawal was predominantly titrated. There were no differences between the groups in terms of the evaluated clinical outcomes. No differences were detected in the incidence of hypotension when weaning was initiated with norepinephrine or vasopressin, although it was non significantly higher in norepinephrine group. In our sample, vasopressin withdrawal was titrated, which differs from North American practice. Brazilian Clinical Trials Registry (REBEC: RBR-10smbw65). gov platform (NCT05506319).

Ear acupuncture with laser and needles in the treatment of anxiety in university students: a randomized clinical trial.

To compare the effectiveness of ear acupuncture with laser and needles in the treatment of anxiety in university students in the post-pandemic context of Covid-19, as well as to evaluate the possible symptoms or adverse reactions triggered by the interventions. Randomized clinical trial carried out with 126 university students, allocated to the "Needle" (control) and "Laser" (experimental) groups. Five ear acupuncture sessions were performed. Assessments were performed before, after the end of treatment and seven days later (follow up), through the State Anxiety Inventory and the measurement of heart and respiratory rates. The Generalized Estimating Equations were used. There was a reduction in anxiety levels in both groups, between the initial and final assessments, and initial and follow up. There was no difference between the groups in the final and follow up. Heart rate decreased in the Needle group between the final and follow up, and initial and follow up assessments; the Laser group remained constant over time and the groups did not differ from each other between the end and follow up. There was no change over time in respiratory rate in either group and they did not differ from each other in the final and follow up assessments. There was a higher occurrence of adverse reactions in the group that received the intervention with needles, despite the mild intensity. Both interventions were effective in reducing anxiety levels in university students. Brazilian Clinical Trials Registry RBR-8cxnvr2.

A Single Session of Beach Tennis with Recreational Athletes Improves Anxiety Symptoms in Women but Not in Men: A Randomized Trial.

Beach tennis has become a popular sport, but research on its mental health benefits is scarce. To the best of our knowledge, no studies have examined the effects of beach tennis on anxiety symptoms. To assess the effect of a single session of beach tennis, in both singles and doubles modes, on anxiety symptoms. Twenty-two recreational players (11 women, age: 35.00 [13.50] years) were evaluated. Each participant underwent three intervention sessions in random order: one-on-one match (singles), two-on-two match (doubles), and a control session (non-exercise). State anxiety and affective responses were measured before and after each intervention. For men, no significant interaction between time and session was found (p = 0.646). In women, there was a significant interaction between time and session (p = 0.002). Anxiety symptoms significantly decreased from pre- to post-singles condition (p = 0.007) and from pre- to post-doubles condition (p = 0.010). A significant difference was observed between the post-singles and post-control conditions (p = 0.002). Beach tennis demonstrated an anxiolytic effect in women, with significant reductions in anxiety symptoms following both singles and doubles sessions. However, no such effects were observed in men. These findings suggest that beach tennis could be a viable intervention for managing anxiety symptoms in women. The study was registered in the Brazilian Clinical Trials Registry (registration code: U1111-1293-7949).

Yoga e a fadiga relacionada ao câncer durante o tratamento do câncer de mama: protocolo de um ensaio clínico randomizado

Cancer-related fatigue is one of the symptoms that most impacts the quality of life of patients undergoing treatment for breast cancer. Yoga has been used as a non pharmacological intervention to alleviate symptoms during breast cancer treatment. However, further studies are needed to elucidate and fill possible gaps regarding the effects of Yoga in this population. This article describes the protocol for a randomized clinical trial that aims to analyze the effects of a Yoga program, compared to a control group, on the physical and psychological outcomes of patients diagnosed with breast cancer, undergoing treatment within the Unified Health System (Sistema Único de Saúde - SUS) in the city of Pelotas, Rio Grande do Sul. Thirty women will be randomized into a Yoga or control group. Participants in the Yoga group will undergo a Yoga program associated with health education, twice a week for eight weeks, with each session lasting 60 minutes. The control group will participate only in health education meetings, once a week, also for eight weeks with sessions of 60 minutes. Assessments of cancer-related fatigue, quality of life, pain, functional capacity, and level of leisure time physical activity will be performed before and after the intervention. Data will be analyzed using Generalized Estimating Equations and Bonferroni post-hoc tests (α = 0.05). The study protocol is registered in the Brazilian Clinical Trials Registry under number RBR- 6vk2vjr.

Effectiveness of negative-pressure wound therapy with instillation compared to standard negative-pressure wound therapy and traditional gauze layer dressing for the treatment of acute traumatic wounds: A randomized controlled trial

Acute traumatic wounds often require prolonged healing time and hospitalization. Negative-pressure wound therapy with instillation and dwell time (NPWTi-d) has demonstrated effectiveness in accelerating patient healing over traditional NPWT, and its benefits are well established in the treatment of chronic infected wounds. However, randomized studies examining the use of NPWTi-d in acute traumatic wounds are scarce. This study aimed to examine the effectiveness of NPWTi-d compared to traditional gauze layer dressing and standard NPWT. This single-center, randomized, pragmatic, controlled clinical trial included 120 adult patients with acute traumatic wounds from traffic accidents randomized to NPWTi-d (n=39), NPWT (n=41), and gauze dressing (n=40). Following surgical debridement of the wound bed, all patients underwent definitive wound closure with delayed primary closure, skin grafting, or surgical flaps. The primary outcomes were wound closure time, number of surgical procedures, and hospital length of stay. The secondary outcomes were primary closure type, amputations, complications, and death. Wound closure time was significantly lower in patients with NPWTi-d compared to patients with NPWT and gauze dressing (6.1 vs. 10 vs. 11.7 days, respectively; p<0.001). Patients with NPWTi-d had fewer surgical procedures than patients with NPWT and gauze dressing (3.0 vs. 3.5 vs. 6.2, respectively; p<0.001). No significant differences in length of stay were observed among the groups. In this study, patients with acute traumatic wounds who received NPWTi-d experienced shorter wound closure time and fewer surgical procedures than patients who received NPWT or gauze dressing. The current study is registered on the Brazilian Clinical Trials Registry (ReBec) platform under the name Comparison between Traditional Dressing, V.A.C. Dressing and V.A.C. Dressing with Instillation in Complex Wounds, ID nº RBR-658g535 at https://ensaiosclinicos.gov.br/rg/RBR-658g535.

Microbiological profile of patients with generalized gingivitis undergoing periodontal therapy and administration of Bifidobacterium animalis subsp. lactis HN019: A randomized clinical trial.

To evaluate the adjunctive use of the probiotic Bifidobacterium animalis subsp. lactis HN019 (B. lactis HN019) to conventional therapy on clinical and microbiological parameters in patients with generalized gingivitis. Sixty systemically healthy individuals with untreated generalized gingivitis were submitted to periodontal therapy and allocated to receive Placebo (n = 30) or Probiotic (n = 30) lozenges, twice a day for 8 weeks. Bleeding on Marginal Probing (BOMP) was evaluated at baseline, after 2 and 8 weeks. Supra and subgingival biofilm were obtained at baseline and 8 weeks post-therapy for analyses by 16S rRNA gene sequencing. Differences between therapeutic groups were analyzed by non-parametric tests (p<0.05). The Placebo and Probiotic groups showed a significant reduction in BOMP at 8 weeks compared to baseline (p<0.05). The Probiotic group had a lower percentage of BOMP when compared with the Placebo group at 8 weeks (p<0.0001). Alpha and beta-diversity showed no statistical significance between groups and time points. At phylum level, no significant differences were observed between groups and time points. At genus level, an increase in the relative abundances of Bergeyella and Corynebacterium were significantly associated with a greater reduction in bleeding in the Placebo group and with less reduction in bleeding in the Probiotic group, respectively. At species level, Schaalia spp., Streptococcus gordonii, and Leptotrichia wadei increased in Placebo and decreased in the Probiotic group after treatment. Granulicatella adiacens decreased significantly after the probiotic therapy, while Saccharibacteria (TM7) spp., Solobacterium moorei, and Catonella morbi increased significantly. In the Placebo group, Bergeyella sp. HMT-322 was associated with a greater percentage of reduction in bleeding. In both groups, Actinomyces species were related to less reduction in bleeding. The adjuvant use of B. lactis HN019 alongside conventional therapy enhanced the reduction in BOMP and promoted greater changes in the microbiological profile of patients with generalized gingivitis. The study was registered at Brazilian Clinical Trials Registry (ReBEC; protocol number: RBR-59v2yb).

Plasma and breast milk adipokines in women across the first year postpartum and their association with maternal depressive symptoms and infant neurodevelopment: Protocol for the APPLE prospective cohort study.

Adiponectin and leptin play important roles in the central nervous system. During the postpartum period, there is a need for a better understanding of the relationship between these cytokines and the neurological development of the infant, as well as their influence on preventing maternal depressive symptoms. To assess the correlation between adiponectin and leptin in maternal plasma and breast milk and their association with: infant neurodevelopment at 6 and 12 months of age; and maternal mental health over the first year postpartum. Prospective cohort study with four follow-up. Mothers and their newborns are recruited within the first 15 days postpartum (baseline). Follow-up visits occur at 2, 6, and 12 months postpartum. Visits include blood and breast milk collection, application of the Edinburgh Postnatal Depression Scale and Beck Depression Inventory to assess maternal mental health, application of the Bayley-III scale for infant developmental assessment, maternal and infant anthropometry and body composition, evaluation of reproductive history, mother-infant bonding, breastfeeding, consumption of ultra-processed foods, sleep quality, and socio-economic and demographic data. The research received funds in August 2022, and participant recruitment began in September 2022. The sample size will consist of 95 mother-child pairs. As of September 2023, 68 participants have been recruited. The project will provide insights into the association between adiponectin and leptin with postpartum depression and infant neurodevelopment, ultimately promoting improved care and quality of life for these groups. Additionally, it will provide data on the type of delivery, infant physical growth, maternal and infant body composition changes, sleep quality, consumption of ultra-processed foods, and maternal metabolic health, including vitamin D metabolites, oxidized polyunsaturated fatty acid metabolites, phospholipid species and triacylglycerols, which are of significant relevance to public health and, when interconnected, may yield important results and contribute to the existing literature. Name of the registry: Brazilian Clinical Trials Registry (ReBec). Registration number: RBR-9hcby8c.

Oral mucositis management with photobiomodulation, Bidens pilosa L. (Asteraceae) and Curcuma longa L. (Zingiberaceae), the FITOPROT herbal medicine, and its influence on inflammatory cytokine levels: a randomized clinical trial.

This randomized clinical trial aimed to compare the effects of a mucoadhesive formula, containing curcuminoids from Curcuma longa L. and glycerinated extract of Bidens pilosa L. (FITOPROT), associated with photobiomodulation (PBM), and of PBM exclusively, on the incidence of oral mucositis (OM)-induced by radiotherapy (RT) in the head and neck region, and the salivary expression of inflammatory cytokines, in patients with head neck cancer. Patients were randomly assigned into two intervention groups-FITOPROT + PBM (n = 25) or PBM (n = 27). PBM protocol comprised a wavelength of 660nm, 25 mW, 0.25J/point, and daily irradiation from the first until the last day of RT. FITOPROT was gargled twice a day. All patients underwent a preventive oral care program throughout the study. OM degree, salivary concentration of nitrite, and inflammatory (IL-1, TNFα, IL-6, IL-8, and IL-12p70), and anti-inflammatory (IL-10) cytokines were assessed at baseline, and at the 7th, 14th, 21st, and 30th RT sessions. There were no differences in the OM degree between groups, but the RT dose significantly affected the OM. The RT significantly affected the salivary nitrite, TNFα, IL-1β, and IL-10 concentrations. FITOPROT associated with PBM showed limited effects on preventing the incidence of severe OM compared to PBM alone. However, FITOPROT + PBM may be associated with nitrite and cytokine balance, which may contribute to the occurrence of fewer cases of severe OM. Brazilian Clinical Trials database (ReBEC; RBR-9vddmr), registered UTN code: U1111-1193-2066, registered in August 8th, 2017.

Online mindfulness-based cognitive therapy for treatment-resistant depression: a parallel-arm randomized controlled feasibility trial.

Treatment-resistant depression (TRD) presents a significant challenge, affecting approximately 30% of individuals diagnosed with major depressive disorder and leading to poor treatment responses. Innovations in digital mental health, especially online mindfulness-based cognitive therapy (eMBCT), offer promising avenues for enhancing access to effective mental health care for individuals with TRD in a clinical setting. The aim of this study was to examine the feasibility of eMBCT in an individual clinical context to decrease depressive symptoms for TRD. Conducted at the Institute of Psychiatry of the Federal University of Rio de Janeiro, Brazil, this parallel-arm, randomized controlled feasibility trial involved outpatients diagnosed with TRD, aged 18 and above. Of the 39 outpatients invited, 28 were randomized into two groups: an intervention group receiving the eMBCT program (n = 15) and a control group (n = 13). The intervention, consisting of an 8-week course, was delivered via live video sessions. Following the assessment period, participants in the control group were offered the eMBCT intervention. Assessments using standardized questionnaires were conducted at the start and end of the study. Within the eMBCT group, improvements were observed in depression symptoms (Z = -3.423; p = 0.001; effect size r = 0.78), anxiety symptoms (Z = -3.361; p = 0.001; effect size r = 0.77), with no significant changes in the control group. Comparatively, the eMBCT group showed significant reductions in depression symptoms and improvements in clinical global impressions over the control group (BDI2: U = 30.5; p = 0.015; effect size r = 0.47, CGI1: U = 21.0; p = 0.004; effect size r = 0.56). eMBCT in an individual format combined with medication, appears to be a feasible treatment for TRD, decreasing symptoms of depression. In a future trial the control group may have a manualized intervention. The Brazilian Clinical Trials Registry: (https://ensaiosclinicos.gov.br/rg/RBR-6zndpbv) and RBR-6zndpbv.

Improving quality of life, sleep and mental health through multicomponent training versus Brazilian recommendations of physical activity in post-COVID-19 patients: CORE-study–A randomized controlled trial

Improving quality of life, sleep and mental health through multicomponent training versus Brazilian recommendations of physical activity in post-COVID-19 patients: CORE-study–A randomized controlled trial

Does Transcranial Direct Current Stimulation reduce central and peripheral muscle fatigue in recreational runners? A triple-blind, sham-controlled, randomized, crossover clinical study

Runners seek health benefits and performance improvement. However, fatigue might be considered a limiting factor. Transcranial Direct Current Stimulation (tDCS) has been investigated to improve performance and reduce fatigue in athletes. While some studies showing that tDCS may improve a variety of physical measures, other studies failed to show any benefit. To evaluate the acute effects of tDCS on central and peripheral fatigue compared to a sham intervention in recreational runners. This is a triple-blind, controlled, crossover study of 30 recreational runners who were randomized to receive one of the two interventions, anodal or sham tDCS, after the fatigue protocol. The interventions were applied to the quadriceps muscle hotspot for 20 min. Peak torque, motor-evoked potential, and perceived exertion rate were assessed before and after the interventions, and blood lactate level was assessed before, during, and after the interventions. A generalized estimated equation was used to analyze the peak torque, motor-evoked potential, and blood lactate data, and the Wilcoxon test was used for perceived exertion rate data. Our findings showed no difference between anodal tDCS and sham tDCS on peak torque, motor-evoked potential, blood lactate, and perceived exertion rate. The tDCS protocol was not effective in improving performance and reducing fatigue compared to a sham control intervention. RBR-8zpnxz.

Evaluation of the effects of pregabalin and dexamethasone coadministration on preemptive multimodal analgesia and anxiety in third molar surgeries: a triple-blind randomized clinical trial.

To evaluate the efficacy of pregabalin and dexamethasone coadministration in preemptive analgesia and anxiety control in lower third molar surgery. A triple-blind, split-mouth clinical trial conducted with patients divided into two groups: control group, receiving placebo and dexamethasone, and test group, receiving pregabalin and dexamethasone preoperatively. The evaluated variables were pain, measured by the Visual Analog Scale (VAS), anxiety assessed through the State-Trait Anxiety Inventory (STAI) questionnaires, hemodynamic parameters [Blood Pressure (BP), Heart Rate (HR), Oxygen Saturation (SpO2)], and sedation assessed by the Ramsay scale. A total of 31 patients were included. The test group exhibited a significant reduction in pain at 2,4,6,8,12,16,24, and 48h after surgery and in the consumption of rescue analgesics. Anxiety, evaluated by STAI and VAS, showed a significant decrease in the test group (p < 0.001). Additionally, there was a significant decrease in BP at most of the assessed time points (p < 0.05) and a significant reduction in HR at two different time intervals (p = 0.003 and p = 0.009), indicating a positive effect in the test group. There was no significant difference in SpO2 between the groups. Sedation assessment revealed a significant difference at all time points favoring the test group (p < 0.05). There were no significant postoperative adverse effects. Pregabalin coadministered with dexamethasone demonstrated significant efficacy in controlling postoperative pain and anxiety, as well as a sedative effect. The coadministration of pregabalin with dexamethasone may presents potential advantages in both pain modulation and psychological well-being of individuals undergoing third molar surgeries. Brazilian Clinical Trials Registry (REBEC), No. RBR-378h6t6.

Effect of cashew nut flour on hematological parameters of children living with HIV.

Aim: To assess the effect of cashew nut flour on the hematological parameters of children living with HIV-AIDS. Method: A 32-week randomized, blind clinical trial conducted at a specialized outpatient clinic. Children aged 2-12 years were allocated to intervention groups (IGs) (n = 11) receiving 12 g/day of cashew nut flour and control groups (CGs) (n = 9) receiving 12 g/day of carboxymethyl cellulose. Parameters of erythrocytes, leukocytes, platelets, and lipid profiles were evaluated. Results: In the IG, the elevation and reduction of leukocyte and lipid profile biomarkers, respectively, were not statistically significant (p > 0.05). A clinically and statistically significant increase in mean corpuscular hemoglobin concentration was observed in the CG (p = 0.018), with a large effect size (Cohen's d = 0.9). There were no statistically significant changes in platelet counts among participants (p = 0.18). The effect size for white blood cell count, low-density lipoprotein cholesterol, very low-density lipoprotein, and triglycerides was moderate in the IG compared to the CG. Conclusion: Cashew nut flour supplementation may increase levels of leukocytes and lipid profile parameters in children living with HIV. Brazilian Clinical Trials Registry (REBEC): U1111.1276.6591.

Effectiveness of Reiki therapy for preoperative anxiety in cardiac surgery: a randomized clinical trial

Objective To assess the effectiveness of a Reiki protocol on anxiety levels in the preoperative period of cardiac surgery. Methods This is a controlled and randomized clinical trial carried out in a university reference hospital in cardiology between June and December 2021. Chunk randomization and allocation by draw with opaque sealed envelopes were carried out in two groups: Control (n=44; not subjected to intervention); and Intervention (n=44; submitted to two Reiki sessions three days before and the day before surgery). The main outcomes (anxiety, well-being and muscle tension) were assessed across sessions using a mixed effects model. To assess the effect size, partial eta squared (η2p) values were calculated. Results Differences in anxiety scores (+2.7 points more than the control), well-being (-0.78) and muscle tension (1.27) were determined, being considered statistically significant (p&lt;0.001). In analyzing the effect size, the experiment better distinguished the variation in the anxiety variable (η2p=0.74) than in the other two variables (η2p=0.14; η2p=0.23). Conclusion The study offers favorable evidence for the effectiveness of Reiki in controlling preoperative anxiety after cardiac surgery. Brazilian Clinical Trials Registry: RBR-2nhgvn6

Myocardial protection: comparing histological effects of single-dose cardioplegic solutions-study protocol for a secondary analysis of the CARDIOPLEGIA trial.

Myocardial protection is crucial for successful cardiac surgery, as it prevents heart muscle damage that can occur during the procedure. Prolonged hypoxia without proper protection can lead to adenosine triphosphate consumption, microvilli loss, blister formation, and edema. Custodiol, del Nido, and modified del Nido are single-dose cardioplegic solutions with proven safety and significance in modern surgery. While each has been independently assessed for patient outcomes, limited research directly compares them. This study aims to compare their myocardial protection using histological analysis. In a double-blind clinical trial, at least 90 patients will be randomly assigned to receive one of the three cardioplegic solutions. Myocardial biopsies will be collected before cardiopulmonary bypass and 15 minutes after reperfusion. The surgical, anesthetic and perfusion techniques will be the same for all patients, following the Institution's standard protocols. The ideal cardioplegic solution does not exist, and its selection remains challenging for surgeons. In modern surgical practice, understanding the behavior of these solutions and the ischemic tissue damage caused during induced cardiac arrest allows for safer surgical procedures. The results of this clinical trial can help in understanding the behavior of cardioplegic solutions and their tissue effects. Thus, by selecting the best cardioplegic solution, ischemic damage can be minimized, enhancing the effectiveness of this essential technique in cardiac procedures. The study may aid in implementing clinical protocols in several institutions, aiming to choose the solution with a superior myocardial protection profile, increasing safety, and reducing expenses. Brazilian Clinical Trials Registry (ReBEC, http://ensaiosclinicos.gov.br/): RBR-997tqhh. Registered: January 26th, 2022.

Effect of gingival barrier brands on operator perception, cervical adaptation, and patient comfort during in-office tooth bleaching: a randomized clinical trial

BackgroundLight-cured resins are widely used as gingival barriers to protect the gums from highly concentrated peroxides used in tooth bleaching. The impact of barrier brand on clinical outcomes is typically considered negligible. However, there is limited evidence on the effects of different brands on operator experience, barrier adaptation, and patient comfort.ObjectiveThis clinical trial assessed the impact of four commercial gingival barrier brands (Opaldam, Topdam, Lysadam, and Maxdam) on operator perception, adaptation quality, and patient comfort.MethodsTwenty-one undergraduate students placed gingival barriers in a randomized sequence using blinded syringes. Photographs of the barriers were taken from frontal and incisal perspectives. After bleaching procedures, operators rated handling features and safety using Likert scale forms. Two experienced evaluators independently assessed barrier adaptation quality on a scale from 1 (perfect) to 5 (unacceptable). The absolute risk of barrier-induced discomfort was recorded. Data were analyzed using Friedman and Chi-square tests (α = 0.05).ResultsOpaldam and Topdam received the highest scores in most handling features, except for removal, which was similar among all brands. No significant difference was observed in barrier adaptation quality between the evaluated brands. Discomforts were mainly reported in the upper dental arch, with Maxdam having the highest absolute risk (35% for this arch and 24% overall).ConclusionsThis study suggests that gingival barrier brands can influence operator perception and patient comfort. Opaldam and Topdam were preferred by operators, but all brands demonstrated comparable adaptation quality.Clinical trial registrationThe study was nested in a randomized clinical trial registered in the Brazilian Clinical Trials Registry under identification number RBR-9gtr9sc.

Efficacy of auriculotherapy for decreasing anxiety and stress among perioperative nursing workers: a mixed study.

to analyze the effectiveness of auriculotherapy for decreasing anxiety and stress of perioperative nursing professionals. mixed methods research, embedded experimental model. In the quantitative stage, a randomized, triple-blind clinical trial was conducted with perioperative nursing professionals, who answered a characterization questionnaire, the List of Signs and Symptoms of Stress, and the General Anxiety Disorder-GAD 7. The participants attended eight auriculotherapy sessions with semi-permanent needles. The qualitative stage was exploratory and descriptive, in which data were collected through semi-structured interviews. Data were mixed with the incorporation of qualitative findings to examine the intervention in the experimental study. 13 professionals participated in the intervention group and 14 in the control group. Anxiety and stress levels decreased significantly within groups, though no statistical difference was found between groups (p>0.05). The central category, "Auriculotherapy as an intervention to treat anxiety and stress," emerged from the qualitative data, which was subdivided into a base unit and three categories concerning the therapy's benefits. applying real and sham auriculotherapy had the same effect on the participants' anxiety and stress levels; the reports reinforced such evidence. Non-pharmacological interventions, such as auriculotherapy, are essential for recovering and promoting the health of perioperative nursing professionals. Brazilian Clinical Trials Registry: RBR-3jvmdn.

Single-session associative protocol for dentin hypersensitivity management: a 1-year randomized, blinded clinical study.

This study aimed to establish a single-session associative protocol for non-restorative management of dentin hypersensitivity (DH). Twenty-four individuals with DH and a minimum sensitivity level of 4 on the visual analog scale (VAS) were selected. The study was conducted in a split-mouth design, with each participant (n = 20) having at least 1 affected tooth in all quadrants. The management protocols consisted of control group: universal adhesive, Neural Desensitizing Protocol group: 5% potassium nitrate, Mixed Desensitizing Protocol (PAM) group: 5% sodium fluoride and 5% potassium nitrate, Remineralizing Desensitizing Protocol (PDR) group: surface-partially reacted glass technology photopolymerizable varnish. Evaluations were performed immediately after application, at 1 week, 1 month, 2 months, and 12 months using the VAS sensitivity test. The scores were subjected to statistical analysis using the Friedman test (p < 0.05), Durbin-Conover test (p < 0.05), and Wilcoxon test (p < 0.05). At the 12-month evaluation, all groups showed statistically significant differences compared to the initial assessment. For the evaluation after 12 months, there was a statistically significant difference between the PAM group, the control group, and the PDR group. It can be concluded that all groups were effective in controlling DH, but there were significant results in the control group and PDR group. The clinical relevance of this study is to demonstrate that the application of single-session desensitizing protocols can be effective in controlling DH for up to 12 months. Brazilian Clinical Trials Registry Identifier: RBR-4r63d7s.