Search results for: randomized trial

Authors: Pramote Thangkratok

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The aims of this experimental study were to investigate the effect of Reverse Trendelenburg Position on the Back Pain after Cardiovascular Angiography and Interventions. In addition, to compare bleeding and hematoma occurrences at the Access site between experimental and control groups. The randomized controlled trial (RCT) was conducted in 70 patients who underwent Cardiovascular Angiography and Interventions via the femoral artery and received post procedural care at the intermediate cardiac care unit, Bangkok Heart Hospital. From December 2015 to February 2016. The control group (35 patients) was to get standard care after the intervention, whereas the experimental group (35 patients) was Reverse Trendelenburg Position 30-45 degrees. The groups were not significantly different in terms of demographic characteristics, Age, Gender, BMI, blood pressure, heart rate. While not significantly different from each other, the intensity of back pain control group had a significantly higher pain score than experimental group. Vascular complications in terms of bleeding and hematoma were not significantly different between the control and experimental groups. The findings show that Reverse Trendelenburg Position after Cardiovascular Angiography and Interventions would reduce or prevent the back pain without increasing the chance of bleeding and hematoma.

Keywords: reverse trendelenburg position, back pain, cardiovascular angiography, cardiovascular interventions

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Authors: Muntanavadee Maytapattana

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The purposes of the study were to evaluate the effectiveness of the Parent Training Program for Obesity Reduction (PTPOR) on health behaviors of school-age children. An Ecological Systems Theory (EST) was approached the study and a randomized control trial was used in this study. Participants were school-age overweight or obese children and their parents. One hundred and one parent-child dyads were recruited and random assigned into the PTPOR (N=30), Educational Intervention or EI (N=32), and control group (N=39). The parents in the PTPOR group participated in five sessions including an educational session, a cooking session, aerobic exercise training, 2-time group discussion sessions, and 4-time telephoned counseling sessions. Repeated Measure ANCOVA was used to analyze data. The results presented that the outcomes of the PTPOR group were better than the EI and the control groups at 1st, 8th, and 32nd weeks after finishing the program such as child exercise behavior (F(2,97) = 3.98, p = .02) and child dietary behavior (F(2,97) = 9.42, p = .00). The results suggest that nurses and health care providers should utilize the PTPOR for child weight reduction and for the health promotion of a lifestyle among overweight and obese children.

Keywords: parent training program, obesity reduction, child health behaviors, school-age children

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Authors: Mark Linden, Rachel Leonard, Trisha Forbes, Michael Brown, Lynne Marsh, Stuart Todd, Nathan Hughes, Maria Truesdale

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Background: Current interventions which aim to improve the mental health of family carers are often face to face, which can create barriers to full participation. Online interventions can offer flexibility in delivery compared to face to face approaches. The primary objective of this study is to determine the feasibility of delivering the Carers-ID online intervention, while the secondary outcome is to improve the mental health of family carers of people with intellectual disabilities. Methods: Family carers (n = 120) will be randomised to receive the intervention (n=60) or assigned to a wait-list control (n=60) group. The intervention (www.Carers-ID.com) consists of fourteen modules which cover topics including promoting resilience, providing peer support, reducing anxiety, managing stress, accessing local supports, managing family conflict and information for siblings who are carers. Primary outcomes for this study include acceptability and feasibility of the outcome measures, recruitment, participation and retention rates and effect sizes. Secondary outcomes will be completed at three time points (baseline, following intervention completion and three months after completion). Secondary outcomes include, depression, anxiety, stress, well-being , resilience and social connectedness. Participants (n=12) who have taken part in the intervention arm of the research will be invited to participate in semi-structured interviews as part of the process evaluation. Discussion: To determine whether a full-scale randomised controlled effectiveness trial is warranted, feasibility testing of the intervention and trial procedures is a necessary first step. The Carers-ID intervention provides an accessible resource for family carers to support their mental health and well-being.

Keywords: intellectual disability, family carer, feasibility trial, online intervention

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Authors: Sandip Shrestha, Ann M. Donoghue, Komala Arsi, Basanta R. Wagle, Abhinav Upadhyay, Dan J. Donoghue

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Campylobacter, one of the major cause of foodborne illness worldwide, is commonly present in the intestinal tract of poultry. Many strategies are currently being investigated to reduce Campylobacter counts on commercial poultry during processing with limited success. This study investigated the efficacy of the generally recognized as safe compound, carvacrol (CR), a component of wild oregano oil as a wash treatment for reducing C. jejuni and aerobic bacteria on chicken skin. A total of two trials were conducted, and in each trial, a total of 75 skin samples (4cm × 4cm each) were randomly allocated into 5 treatment groups (0%, 0.25%, 0.5%, 1% and 2% CR). Skin samples were inoculated with a cocktail of four wild strains of C. jejuni (~ 8 log10 CFU/skin). After 30 min of attachment, inoculated skin samples were dipped in the respective treatment solution for 1 min, allowed to drip dry for 2 min and processed at 0, 8, 24 h post treatment for enumeration of C. jejuni and aerobic bacterial counts (n=5/treatment/time point). The data were analyzed by ANOVA using PROC GLM procedure of SAS 9.3. All the tested doses of CR suspension consistently reduced C. jejuni counts across all time points. The 2% CR wash was the most effective treatment and reduced C. jejuni counts by ~4 log₁₀ CFU/sample (P < 0.05). Aerobic counts were reduced for the 0.5% CR dose at 0 and 24h in Trial 1 and at 0, 8 and 24h in Trial 2. The 1 and 2% CR doses consistently reduced aerobic counts in both trials up to 2 log₁₀ CFU/skin.

Keywords: Campylobacter jejuni, carvcrol, chicken skin, postharvest

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Authors: Prakash M.N, Mahesh G, Muhammed Rafi K.M, Shiju P. Nair

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Introduction: In launch vehicle missions, Reaction Control thrusters are being used for the three-axis stabilization of the vehicle during the coasting phases. A pressure-fed propulsion system is used for the operation of these thrusters due to its less complexity. In liquid stages, these thrusters are designed to draw propellant from the same tank used for the main propulsion system. So in order to regulate the propellant flow rates of these thrusters, flow control orifices are used in feed lines. These orifices are calibrated separately as per the flow rate requirement of individual thrusters for the nominal operating conditions. In some missions, it was observed that the thrusters were operated at higher thrust than nominal. This point was addressed through a series of cold flow and hot tests carried out in-ground and this paper elaborates the details of the same. Discussion: In order to find out the exact reason for this phenomenon, two flight configuration thrusters were identified and hot tested in the ground with calibrated orifices and feed lines. During these tests, the chamber pressure, which is directly proportional to the thrust, is measured. In both cases, chamber pressures higher than the nominal by 0.32bar to 0.7bar were recorded. The increase in chamber pressure is due to an increase in the oxidizer flow rate of both the thrusters. Upon further investigation, it is observed that the calibration of the feed line is done with ambient pressure downstream. But in actual flight conditions, the orifices will be subjected to operate with 10 to 11bar pressure downstream. Due to this higher downstream pressure, the flow through the orifices increases and thereby, the thrusters operate with higher chamber pressure values. Conclusion: As part of further investigatory tests, two numbers of fresh thrusters were realized. Orifice tuning of these thrusters was carried out in three different ways. In the first trial, the orifice tuning was done by simulating 1bar pressure downstream. The second trial was done with the injector assembled downstream. In the third trial, the downstream pressure equal to the flight injection pressure was simulated downstream. Using these calibrated orifices, hot tests were carried out in simulated vacuum conditions. Chamber pressure and flow rate values were exactly matching with the prediction for the second and third trials. But for the first trial, the chamber pressure values obtained in the hot test were more than the prediction. This clearly shows that the flow is detached in the 1st trial and attached for the 2nd & 3rd trials. Hence, the error in tuning the flow control orifices is pinpointed as the reason for this higher chamber pressure observed in flight.

Keywords: reaction control thruster, propellent, orifice, chamber pressure

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Authors: Rafael Tedrus Bento

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The analysis of proportionality as a test is raised as a basic foundation for the achievement of Fundamental Rights. We used legal dogmatics and empirical analysis to seek the expected results, from the reading of the RV Oakes trial by the Supreme Court of Canada. In cases involving freedom of expression, two tests are used to resolve disputes. The first examines whether, in fact, the case can be characterized as a violation of freedom of expression; the second assesses whether this violation can be justified by the reasonable limit clause. This test was defined in the RV Oakes trial by the Supreme Court of Canada, concluding with the Oakes Test, used worldwide as a proportionality test. Resulting is a proportionality between the effects of the limiting measure and the objective - the more serious the harmful effects of a measure, the more important the objective must be.

Keywords: Oakes, proportionality, fundamental rights, Supreme Court of Canada

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Authors: Yaxian Chen, Yeonhee Park

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Driven by evolving FDA recommendations, modern clinical trials demand innovative designs that strike a balance between statistical rigor and ethical considerations. Covariate-adjusted response-adaptive (CARA) designs bridge this gap by utilizing patient attributes and responses to skew treatment allocation in favor of the treatment that is best for an individual patient’s profile. However, existing CARA designs for survival outcomes often hinge on specific parametric models, constraining their applicability in clinical practice. In this article, we address this limitation by introducing a CARA design for survival outcomes (CARAS) based on the Cox model and a variance estimator. This method addresses issues of model misspecification and enhances the flexibility of the design. We also propose a group sequential overlapweighted log-rank test to preserve type I error rate in the context of group sequential trials using extensive simulation studies to demonstrate the clinical benefit, statistical efficiency, and robustness to model misspecification of the proposed method compared to traditional randomized controlled trial designs and response-adaptive randomization designs.

Keywords: cox model, log-rank test, optimal allocation ratio, overlap weight, survival outcome

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Authors: Shashank Tiwari, S. P. Mahapatra

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The aim of this technique is to reduce the steps of process scales up, save time & cost of the industries. This technique will minimise the steps of process scale up. The new steps are, Novel Lab Scale, Novel Lab Scale Trials, Novel Trial Batches, Novel Exhibit Batches, Novel Validation Batches. In these steps, it is not divided to validation batches in three parts but the data of trials batches, Exhibit Batches and Validation batches are use and compile for production and used for validation. It also increases the batch size of the trial, exhibit batches. The new size of trials batches is not less than fifty Thousand, the exhibit batches increase up to two lack and the validation batches up to five lack. After preparing the batches all their data & drugs use for stability & maintain the validation record and compile data for the technology transfer in production department for preparing the marketed size batches.

Keywords: batches, technique, preparation, scale up, validation

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Authors: Thomas S. Abia II

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Intel Chandler Site has internally developed its first-of-kind (FOK) facility-scale wastewater treatment system to achieve multi-metal ion exchange. The process was carried out using a serial process train of carbon filtration, pH / ORP adjustment, and cationic exchange purification to treat dilute metal wastewater (DMW) discharged from a substrate packaging factory. Spanning a trial period of 10 months, a total of 3,271 samples were collected and statistically analyzed (average baseline + standard deviation) to evaluate the performance of a 95-gpm, multi-reactor continuous copper ion exchange treatment system that was consequently retrofitted for manganese ion exchange to meet environmental regulations. The system is also equipped with an inline acid and hot caustic regeneration system to rejuvenate exhausted IX resins and occasionally remove surface crud. Data generated from lab-scale studies was transferred to system operating modifications following multiple trial-and-error experiments. Despite the DMW treatment system failing to meet internal performance specifications for manganese output, it was observed to remove the cation notwithstanding the prevalence of copper in the waste stream. Accordingly, the average manganese output declined from 6.5 + 5.6 mg¹L⁻¹ at pre-pilot to 1.1 + 1.2 mg¹L⁻¹ post-pilot (83% baseline reduction). This milestone was achieved regardless of the average influent manganese to DMW increasing from 1.0 + 13.7 mg¹L⁻¹ at pre-pilot to 2.1 + 0.2 mg¹L⁻¹ post-pilot (110% baseline uptick). Likewise, the pre-trial and post-trial average influent copper values to DMW were 22.4 + 10.2 mg¹L⁻¹ and 32.1 + 39.1 mg¹L⁻¹, respectively (43% baseline increase). As a result, the pre-trial and post-trial average copper output values were 0.1 + 0.5 mg¹L⁻¹ and 0.4 + 1.2 mg¹L⁻¹, respectively (300% baseline uptick). Conclusively, the operating pH range upstream of treatment (between 3.5 and 5) was shown to be the largest single point of influence for optimizing manganese uptake during multi-metal ion exchange. However, the high variability of the influent copper-to-manganese ratio was observed to adversely impact the system functionality. The journal herein intends to discuss the operating parameters such as pH and oxidation-reduction potential (ORP) that were shown to influence the functional versatility of the ion exchange system significantly. The literature also proposes to discuss limitations of the treatment system such as influent copper-to-manganese ratio variations, operational configuration, waste by-product management, and system recovery requirements to provide a balanced assessment of the multi-metal ion exchange process. The take-away from this literature is intended to analyze the overall feasibility of ion exchange for metals manufacturing facilities that lack the capability to expand hardware due to real estate restrictions, aggressive schedules, or budgetary constraints.

Keywords: copper, industrial wastewater treatment, multi-metal ion exchange, manganese

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Authors: M. Khaledi Pour, P. Akbartehrani, M. Amini, M. Khani, M. Mohajeri Tehrani, R. Radi, B. Shokri

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Diabetic Foot Ulcer (DFU) is one of the costly severe complications of diabetes. Neuropathy and Peripheral Arterial Disease (PAD) due to diabetes are significant causes of this complication. In 10 years the patients with DFUs are twice as likely to die as patients without DFUs. Cold Atmospheric Plasma (CAP) is a promising tool for medical purposes. CAP generate reactive species at room temperature and are effective in killing bacteria and fibroblast proliferation. These CAP-based tools produce NO, which has bactericidal and angiogenesis properties. It also showed promising effects in the DFUs surface reduction and the time to wound closure. In this paper, we evaluated the effect of the Argon Plasma Jet (APJ) on the healing process of the Wagner Grade 2 DFUs in a randomized clinical trial. The 20 kHz sinusoidal voltage frequency derives the APJ. Patients (n=20) were randomly double-blinded assigned into two groups. These groups receive the standard care (SC, n=10) and the standard care with APJ treatment (SC+APJ, n=10) for five sessions in four weeks. The results showed that the APJ treatment along standard care could reduce the wound surface by 20 percent more than the standard care. Also, It showed a more influential role in controlling wound infection.

Keywords: argon plasma jet, cold atmospheric plasma, diabetes, diabetic foot ulcer

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Authors: K. Abuzayan, H. Alabed

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The objectives of this study (baseline study, n = 20) were to implement Matlab procedures for quantifying selected static balance variables, establish baseline data of selected variables which characterize static balance activities in a population of healthy young adult males, and to examine any trial effects on these variables. The results indicated that the implementation of Matlab procedures for quantifying selected static balance variables was practical and enabled baseline data to be established for selected variables. There was no significant trial effect. Recommendations were made for suitable tests to be used in later studies. Specifically it was found that one foot-tiptoes tests either in static balance is too challenging for most participants in normal circumstances. A one foot-flat eyes open test was considered to be representative and challenging for static balance.

Keywords: static balance, base of support, baseline data, young adults

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Authors: Joanna Bajerska, Sylwia Mildner-Szkudlarz, Pawel Górnas, Dalija Segliņac

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Sour cherry pomace (CP) by-products obtained during fruit processing, was used to replace the wheat flour in muffin formula on the levels 20% (CP20) and 30% (CP30). The sensory profile of this muffins were characterized, and their impact on glycemic response and appetite sensation were studied. Randomized crossover study where test subjects were given either plain muffin (PM) or CP20 or CP30 during 2 different occasions. In the first study test muffins with equivalent of 50 g available carbohydrate were consumed. Blood glucose was measured before and up to 120 min after consuming the test muffins. To study satiety response in the second trial of the test muffins (portion 1700 kJ per serve) were ingested. Sensory analysis was performed earlier by a sensory panel consisting of 10 well-trained individuals. It is acceptable to incorporate CP into a muffin formula at concentrations up to 30%. With the CP muffins treatment, the glucose responses were significantly lower at 30, 45 and 60 min of the intervals also the incremental peak glucose was 0.40 mmol/L and 0.60 mmol/L lower than for PM. CP20 and CP30 also improved satiety as compared to PM. CP can be a good functional ingredient of functional bakery products to assist in managing glucose levels and satiety in healthy individuals.

Keywords: muffins, postprandial glucose, sensory analysis, satiety sour cherry pomace

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Authors: Samira Rabiei, Faezeh Askari, Reza Rastmanesh

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Objective: To evaluate the effects of nutrition education and adherence to a healthy diet on glycemic and lipidemic control in patients with T2DM. Material and Methods: A randomized controlled trial was conducted on 494 patients with T2DM, aged 14-87 years from both sexes who were selected by convenience sampling from referees to Aliebneabitaleb hospital in Ghom. The participants were divided into two 247 person groups by stratified randomization. Both groups received a diet adjusted based on ideal body weight, and the intervention group was additionally educated about healthy food choices regarding diabetes. Information on medications, psychological factors, diet and physical activity was obtained from questionnaires. Blood samples were collected to measure FBS, 2 hPG, HbA1c, cholesterol, and triglyceride. After 2 months, weight and biochemical parameters were measured again. Independent T-test, Mann-Whitney, Chi-square, and Wilcoxon were used as appropriate. Logistic regression was used to determine the odds ratio of abnormal glycemic and lipidemic control according to the intervention. Results: The mean weight, FBS, 2 hPG, cholesterol and triglyceride after intervention were significantly lower than before that (p < 0.05). Discussion: Nutrition education plus a weigh reducer diet is more effective on glycemic and lipidemic control than a weight reducer diet, alone.

Keywords: type 2 diabetes mellitus, nutrition education, glycemic control, lipid profile

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Authors: Dovile Petkeviciute-Barysiene

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Legal technologies not only create new ways for accessing and providing legal services but also transform the role of legal practitioners. Both lawyers and users of legal services expect automated solutions to outperform people with objectivity and impartiality. Although fairness of the automated decisions is crucial, research on assessing various characteristics of automated processes related to the perceived fairness has only begun. One of the major obstacles to this research is the lack of comprehensive understanding of what legal actions are automated and could be meaningfully automated, and to what extent. Neither public nor legal practitioners oftentimes cannot envision technological input due to the lack of general without illustrative examples. The aim of this study is to map decision making stages and automation levels which are and/or could be achieved in legal actions related to pre-trial and trial processes. Major legal decisions and judgments are identified during the consultations with legal practitioners. The dual-process model of information processing is used to describe cognitive processes taking place while making legal decisions and judgments during pre-trial and trial action. Some of the existing legal technologies are incorporated into the analysis as well. Several published automation level taxonomies are considered because none of them fit well into the legal context, as they were all created for avionics, teleoperation, unmanned aerial vehicles, etc. From the information processing perspective, analysis of the legal decisions and judgments expose situations that are most sensitive to cognitive bias, among others, also help to identify areas that would benefit from the automation the most. Automation level analysis, in turn, provides a systematic approach to interaction and cooperation between humans and algorithms. Moreover, an integrated map of legal decisions and judgments, information processing characteristics, and automation levels all together provide some groundwork for the research of legal technology perceived fairness and acceptance. Acknowledgment: This project has received funding from European Social Fund (project No 09.3.3-LMT-K-712-19-0116) under grant agreement with the Research Council of Lithuania (LMTLT).

Keywords: automation levels, information processing, legal judgment and decision making, legal technology

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Authors: E. Gopi, E. Devaindran

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Objective: Non-operative management of blunt splenic trauma have started to overtake the traditional splenectomy in recent years across the grade of splenic injury. The two main non-operative methods are observation and angioembolisation. However, the post management convalescence in these groups are still being investigated. The study attempts to quantify the clinical indicators among the two in particular complications, mortalities, conversions to operative management and duration of inpatient stay. Methodology: A systematic search was done via PUBMED, MEDLINE, and EMBASE. A total of 639 articles identified and subsequently 68 articles were identified post duplicates, full text, and inclusion and exclusion criteria. Main exclusions were non-English articles without English translation, pure observational or angioembolisation articles of which no comparison data could be identified and articles looking into pure hemodynamically unstable patients. Results: 24 non randomized controlled trial, 5 clinical control trial and 39 retrospective studies analyzing a total of 23700 patients with blunt splenic trauma. Discrepancies in data were noted in the group who had observational management versus angioembolisation in particular as data was compared among the classes of splenic rupture, the protocol of management in different centers, availability of angiogram suite, and the study design. Further variability was also noted in the angioembolisation arm as the preference for treatment differs between distal versus proximal splenic artery involvement. Overall the cumulative mortality in both observational and angioembolisation group were similar, 2.78% and 5.97% respectively. The cause of death however is not directly attributed to the management itself but rather patient comorbidities, other associated injuries and conversions to splenectomy leading to post splenectomy complications. The cumulative morbidity among each group appears to be same approximately 12% in observational versus 15% in angioembolisation. However, the type of complications varies with the observational group having higher rates of inpatient stay and intrabdominal hematoma infection and angioembolisation group developing more splenic infarcts and bleeds. There were significant disparity in reporting the actual data on duration of inpatient stay and complications to allow a statistically significant quantitative analysis to be done, 15 articles however are currently being considered. Conclusions: Observational management appears to be much effective in managing lower grade splenic trauma (grade 1 and 2) where else angioembolisation appears to play a bigger role in intermediate grades (grade 3-4) in ensuring splenic function preservation. Care has to be taken however in the angioembolisation group in view of distal splenic infarct group compromising splenic function. The cumulated data of 15 articles are now being considered for a meta-analysis.

Keywords: blunt splenic trauma, conservative, non-operative, angioembolisation

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Authors: Man Ying Kang, Joshua Kin Man Nan

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The prolonged pandemic has posed alarming public health challenges to various parts of the world, and face-to-face mental health treatment is largely discounted for the control of virus transmission, online psychological services and self-help mental health kits have become essential. Online self-help mindfulness-based interventions have proved their effects on fostering mental health for different populations over the globe. This paper was to test the effectiveness of an online short-term audio-based mindfulness (SAM) program in enhancing wellbeing, dispositional mindfulness, and reducing stress and negative affect in community settings in China, and to explore possible mechanisms of how dispositional mindfulness, stress, and negative affect influenced the intervention effects on wellbeing. Community-dwelling adults were recruited via online social networking sites (e.g., QQ, WeChat, and Weibo). Participants (n=100) were randomized into the mindfulness group (n=50) and a waitlist control group (n=50). In the mindfulness group, participants were advised to spend 10–20 minutes listening to the audio content, including mindful-form practices (e.g., eating, sitting, walking, or breathing). Then practice daily mindfulness exercises for 3 weeks (a total of 21 sessions), whereas those in the control group received the same intervention after data collection in the mindfulness group. Participants in the mindfulness group needed to fill in the World Health Organization Five Well-Being Index (WHO), Positive and Negative Affect Schedule (PANAS), Perceived Stress Scale (PSS), and Freiburg Mindfulness Inventory (FMI) four times: at baseline (T0) and at 1 (T1), 2 (T2), and 3 (T3) weeks while those in the waitlist control group only needed to fill in the same scales at pre- and post-interventions. Repeated-measure analysis of variance, paired sample t-test, and independent sample t-test was used to analyze the variable outcomes of the two groups. The parallel process latent growth curve modeling analysis was used to explore the longitudinal moderated mediation effects. The dependent variable was WHO slope from T0 to T3, the independent variable was Group (1=SAM, 2=Control), the mediator was FMI slope from T0 to T3, and the moderator was T0NA and T0PSS separately. The different levels of moderator effects on WHO slope was explored, including low T0NA or T0PSS (Mean-SD), medium T0NA or T0PSS (Mean), and high T0NA or T0PSS (Mean+SD). The results found that SAM significantly improved and predicted higher levels of WHO slope and FMI slope, as well as significantly reduced NA and PSS. FMI slope positively predict WHO slope. FMI slope partially mediated the relationship between SAM and WHO slope. Baseline NA and PSS as the moderators were found to be significant between SAM and WHO slope and between SAM and FMI slope, respectively. The conclusion was that SAM was effective in promoting levels of mental wellbeing, positive affect, and dispositional mindfulness as well as reducing negative affect and stress in community settings in China. SAM improved wellbeing faster through the faster enhancement of dispositional mindfulness. Participants with medium-to-high negative affect and stress buffered the therapy effects of SAM on wellbeing improvement speed.

Keywords: mindfulness, negative affect, stress, wellbeing, randomized control trial

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Authors: Davit Khachatryan, Shuo Xiang

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Numerous published studies on the use of prazosin in the treatment of PTSD-related sleep disturbances in adult population have resulted in updates to the recommendation for prazosin for nightmares that showed its strength of evidence elevated from C to B in the US Department of Veterans Affairs clinical practice guideline. In addition, the American Academy of Sleep Medicine clinical practice guideline gave prazosin a level-A recommendation for the treatment of PTSD-associated nightmares. The aim of this review is to summarize the available literature for prazosin use for nightmares and other sleep disturbances in children and adolescents with PTSD. Method: A comprehensive search for studies on prazosin use for sleep disturbances in child and adolescent population with PTSD has been performed. We looked at MEDLINE, EMBASE, PsycINFO, CINAHL, AMED, Scopus, Web of Science, and Cochrane CENTRAL databases. Results: Compared to adult population with similar psychopathology, the available literature in child and adolescent population is scarce. Despite increased interest in prazosin in the management of PTSD, only six studies investigating this medication in children and adolescents have been published. Conclusion: A large randomized control trial on this topic is needed for more definite evidence on the efficacy and safety of prazosin in the treatment of nightmares in children and adolescents with PTSD.

Keywords: guidelines, prazosin, PTSD, sleep disturbance

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Authors: Marzieh Moattari Mitra Abbasi, Masoud Mousavinasab, Poorahmad

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Background: Nurses in their daily practice need to communicate with patients and their families as well as health professional team members. Effective communication contributes to patients’ satisfaction which is a fundamental outcome of nursing practice. There are some evidences in support of patients' dissatisfaction with nurses’ performance in communication process. Therefore improving nurses’ communication skills is a necessity for nursing scholars and nursing administrators. Objective: The aim of the present study was to evaluate the effect of a 2-days workshop on nurses’ competencies and performances in communication in a central hospital located in the sought of Iran. Materials and Method: This is a randomized controlled trial which comprised of a convenient sample of 70 eligible nurses, working in a central hospital. They were randomly divided into 2 experimental and control groups. Nurses’ competencies was measured by an Objective Structured Clinical Examination (OSCE) and their performance was measured by asking eligible patients hospitalized in the nurses work setting during a one month period to evaluate nurses' communication skills before and 2 months after intervention. The experimental group participated in a 2 day workshop on communication skills. Content included in this workshop were: the importance of communication (verbal and non verbal), basic communication skills such as initiating the communication, active listening and questioning technique. Other subjects were patient teaching, problem solving, and decision making, cross cultural communication and breaking bad news. Appropriate teaching strategies such as brief didactic sessions, small group discussion and reflection were applied to enhance participants learning. The data was analyzed using SPSS 16. Result: A significant between group differences was found in nurses’ communication skills competencies and performances in the posttest. The mean scores of the experimental group was higher than that of the control group in the total score of OSCE as well as all stations of OSCE (p<0.003). Overall posttest mean scores of patient satisfaction with nurse's communication skills and all of its four dimensions significantly differed between the two groups of the study (p<0.001). Conclusion: This study shows that the education of nurses in communication skills, improves their competencies and performances. Measurement of Nurses’ communication skills as a central component of efficient nurse patient relationship by valid and reliable methods of evaluation is recommended. Also it is necessary to integrate teaching of communication skills in continuing nursing education programs. Trial Registration Number: IRCT201204042621N11

Keywords: communication skills, simulation, performance, competency, objective structure, clinical evaluation

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Authors: Mathieu Audet, Monica Soliman, Emilie Eve Gravel, Rebecca Friesdorf

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Access to higher education is critical for reducing social inequalities. The Canada Learning Bond (CLB) is a government savings incentive aimed at increasing higher education access for children of low income families by providing money toward a Registered Education Savings Plan. To better understand the educational and financial decision-making of low income families, Employment Social Development Canada conducted qualitative fieldwork with eligible parents and children, teachers, and community organizations promoting the Bond. Insights from this fieldwork were then used to develop letters to better target the needs and experiences of eligible families. In the present study, we conducted a randomized controlled trial with children ages 12 to 13, the oldest cohort of eligible children, to test the effectiveness of the new letters. Parents or caregivers of 150,088 eligible children were assigned to one of five letter conditions promoting the Bond or to a control condition that did not receive a letter. The letter conditions were: (a) the standard letter from past outreach, (b) a letter presenting the exact amount the child was eligible to receive, enhancing the salience of benefits, (c) a letter with a social norm, (d) a letter with an image emphasizing the feasibility of higher education by presenting the diversity of options (i.e., college, trade schools, apprenticeships) – many participants interviewed viewed that university was unfeasible, and (e) a letter minimizing references to 'saving' (i.e., not framing the Bond explicitly as a savings incentive) – a concept that did not resonate with low income families who felt they could not afford to save. The exact amount was also presented in letters (c) through (e). The letter minimizing references to 'saving' and presenting the exact amount had the highest net take-up rate at 6.6%, compared to 3.5% for the standard letter group. Furthermore, this trial’s BI-informed letters showed the largest impact on take-up so far, with a net take-up of 5.7% compared to 3.0% and 3.9% in the first two trials. This research highlights the value of mixed-method approaches combining qualitative and behavioural insights methods for developing context-sensitive interventions for social programs. By gaining a deeper understanding of the needs and experiences of program users through qualitative fieldwork, and then integrating these insights into behaviourally informed communications, we were able to increase take-up of an education savings program, which may ultimately improve access to higher education in children of low income families.

Keywords: access to higher education, behavioral insights, government, innovation, mixed-methods, social programs

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Authors: Jiewei Li, Hongyan Cui, Chunqi Chang, Yong Hu

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It was expected to benefit patient with hemiparesis after stroke by extensive arm rehabilitation, to partially regain forearm and hand function. This paper propose a robotic rehabilitation arm in assisting the hemiparetic patient to learn new ways of using and moving their weak arms. In this study, the robotic arm was driven by a somatosensory stimulated brain computer interface (BCI), which is a new modality BCI. The use of somatosensory stimulation is not only an input for BCI, but also a electrical stimulation for treatment of hemiparesis to strengthen the arm and improve its range of motion. A trial of this robotic rehabilitation arm was performed in a stroke patient with pure motor hemiparesis. The initial trial showed a promising result from the patient with great motivation and function improvement. It suggests that robotic rehabilitation arm driven by somatosensory BCI can enhance the rehabilitation performance and progress for hemiparetic patients after stroke.

Keywords: robotic rehabilitation arm, brain computer interface (BCI), hemiparesis, stroke, somatosensory stimulation

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Authors: Jane Aleksoski

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The mode of inheritance and heterotic effect were studied in ten F1 crosses obtained by one-way diallel crossing between five parental genotypes: MV-1, P 76/86, Adiyaman, Basma-Djebel, and P 66 9 7. The following quantitative traits were studied: the number of leaves per stalk, length of leaves from the middle belt of the stalk, and yield of green leaf mass per stalk and per hectare. The trial was set up in the experimental field of Scientific Tobacco Institute - Prilep, using a randomized block design with four replications in the period 2018-2019. Traditional cultural practices were applied during the growing season of tobacco in the field. The aim of this work was to study the mode of inheritance of the quantitative traits, to detect heterosis in the F1 generation, and to assess its economic viability. Analysis of variance determined statistically significant differences in traits between parents and their hybrids in the two-year investigation. The most common way of trait inheritance is partial-dominant, then intermediate. The negative heterotic effect on the number of leaves per stalk has P 76/86 x P 66 9 7. The hybrids MV-1 x Adiyaman, P 76/86 x Basma-Djebel, P 76/86 x P 66 9 7, and Basma-Djebel x P 66 9 7 have a positive heterotic effect on the length of the leaves. Oriental hybrids, where one of the parents is variety P 66 9 7, have positive heterosis in the yield of green leaf mass per stalk. The investigation provides very useful guidance for future successive selection activities.

Keywords: dominance, heterosis, inheritance, tobacco.

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Authors: Zasha Romero, Roberto Trevino, Lin Wang, Elizabeth Alanis, Jesus Cuellar

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Background: There is a strong relationship between low cardiorespiratory fitness (CRF) and high adiposity levels. The purpose of this study was to assess the effects of the Bienestar/Neema Coordinated School Health Program (BN CSHP) on the CRF of preschool children. Methods: This is a randomized cluster trial conducted in preschools of two school districts located along the Texas-Mexico border. Of 48 eligible schools, 28 were randomly selected (intervention, n=14; control, n=14). Family demographics and household health characteristics were collected from parents. CRF, as measured by the Progressive Anaerobic Capacity Endurance Run (PACER) fitness test, was collected from the children. A generalized linear mixed model (GLMM) was used to analyze the data. Results: Family demographics, household health characteristics, and children’s weight, obesity prevalence, and sedentary activity were similar among both treatment groups. After adjusting for covariates, the number of laps run by children in the control group increased by 23% (CI: -5% to 60%) per each data collection period compared with 53% (CI: 7% to 119%) in the intervention group. Conclusions: Children in the BN CSHP, compared to those in the control group, had a significantly higher increase in their CRF. This finding is important because of the health benefits of CRF in children.

Keywords: coordinated school health program, cardiorespiratory fitness, obesity, border health, preschool, physical education, movement

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Authors: Mohamed Eftal Bin Mohamed Ebrahim, Alexander Varey

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Aim: Topical negative pressure has been shown to enhance angiogenesis during wound healing, both for open and closed wounds. Since angiogenesis is a key requirement for successful fat grafting, there may be a role for topical negative pressure as a means of enhancing the take rate during autologous fat grafting to breasts. Here we present a systematic review of the literature on this topic. Methods: Ovid and Embase were utilized, with searches ranging between 1960 – 2019. Terms (“Liposculpting” OR “Fat grafting” OR “Lipofilling” OR “Lipograft” OR “Fat transfer”) AND (“Negative Pressure” OR “Brava” OR “Kiwi”) AND (“Breast”) were merged as keywords. Inclusion criteria were females, autologous fat graft to breast with topical negative pressure prior to the procedure. Studies were excluded if there was no primary endpoint or non-original article. Results: Upon reviewing 219 articles, 2 met inclusion criteria. A total of 565 and 46 breasts in each article were treated respectively using the negative pressure device BRAVA®, with each cohort having different pre-and post-operative pressure settings. Khouri et al. cohort had higher graft survival (79%) compared to Del Vecchio et al. cohort (64%); however, the latter had fewer complications compared to Khouri’s cohort, e.g., fat necrosis, pneumothorax and infection. Conclusion: There is limited evidence regarding the use of topical negative pressure for fat grafting to the breasts. However, in the two studies published, the reported rates of success are high, suggesting there may be a benefit. Consequently, a randomized controlled trial on this area is required.

Keywords: fat grafting, lipograft, negative pressure, breast, breast augmentation, brava

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Authors: Shekoufeh Behdad, Sahar Yadegari, Alireza Ghehrazad, Amirhossein Yadegari

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Background: In this study, we compared the effect of intravenous dexamethasone with placebo on hemodynamic variables and hypotension in patients undergoing cesarean section under spinal anesthesia. Materials and methods: This double-blind, randomized clinical trial was conducted with the approval of the university ethics committee. Written informed consent was obtained from all participating patients. Before spinal anesthesia, patients were randomly assigned to receive either dexamethasone (8 mg IV) or placebo (normal saline). Hemodynamic variables, including systolic, diastolic, and mean arterial blood pressures, as well as heart rate, were measured before drug administration and every 3 minutes until the birth of the neonate and then every 5 minutes until the end of surgery. Side effects such as hypotension, bradycardia, nausea, and vomiting were assessed and recorded for all the patients. Results: There were no significant differences in mean systolic, diastolic, and mean arterial blood pressures before and after administration of the studied drugs in both groups (P.Value>0.05), but heart rate and the incidence of hypotension in the dexamethasone group were less than placebo significantly. Conclusions: Intravenous administration of 8 mg dexamethasone before spinal anesthesia in females undergoing cesarean section can reduce the incidence of post-spinal hypotension without causing serious side effects.

Keywords: cesarean section, hypotension, spinal anesthesia, dexamethasone

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Authors: Tahsien Mohamed Okasha

Abstract:

We hypothesized that Post cardiac arrest patients with Glasgow coma scale (GCS) score of less than (8) and who will be exposed to therapeutic hypothermia protocol will exhibit improvement in their neurological performance. Purposive sample of 17 patients who were fulfilling the inclusion criteria during one year collected. The study carried out using Quasi-experimental research design. Four Tools used for data collection of this study: Demographic and medical data sheet, Post cardiac arrest health assessment sheet, Bedside Shivering Assessment Scale (BSAS), and Glasgow Pittsburgh cerebral performance category scale (CPC). Result: the mean age was X̅ ± SD = 53 ± 8.122 years, 47.1% were arrested because of cardiac etiology. 35.3% with initial arrest rhythm ventricular tachycardia (VT), 23.5% with ventricular fibrillation (VF), and 29.4% with A-Systole. Favorable neurological outcome was seen among 70.6%. There was significant statistical difference in WBC, Platelets, blood gases value, random blood sugar. Also Initial arrest rhythm, etiology of cardiac arrest, and shivering status were significantly correlated with cerebral performance categories score. therapeutic hypothermia has positive effects on neurological performance among post cardiac arrest patients with GCS score of less than (8). replication of the study on larger probability sample, with randomized control trial design. Further study for suggesting nursing protocol for patients undergoing therapeutic hypothermia.

Keywords: therapeutic hypothermia, neurological performance, after resuscitation from cardiac arrest., resuscitation

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Authors: Ahmed M. F. El Shiwi

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Background: Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Myofascial pain syndrome is a condition characterized by muscles shortening with increased tone and associated with trigger points that aggravated with the activity of daily living. Purpose: To examine the effects of magnetic field therapy in patients with lower back myofascial pain syndrome. Methods: Thirty patients were assigned randomly into two groups. Subjects in the experimental group (n=15) with main age of 36.73 (2.52) received traditional physical therapy program (Infrared radiation, ultrasonic, stretching and strengthening exercises for back muscles) as well as magnetic field, and control group (n=15) with main age of 37.27 (2.52) received traditional physical therapy only. The following parameters including pain severity, functional disability and lumbar range of motion (flexion, extension, right side bending, and left side bending) were measured before and after four weeks of treatment. Results: The results showed significant improvement in all parameters in the experimental group compared with those in the control group. Interpretation/Conclusion: By the present date, it is possible to conclude that a magnetic field is effective as a method of treatment for lower back myofascial pain syndrome patients with the parameters used in the present study.

Keywords: magnetic field, lower back pain, myofascial pain syndrome, biological systems engineering

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Authors: Mahasen M. Abdel Mageed, H. S. Zaghloul

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Annihilations, phase shifts, scattering lengths, and elastic cross sections of low energy positrons scattering from magnesium atoms were studied using the least-squares variational method (LSVM). The possibility of positron binding to the magnesium atoms is investigated. A trial wavefunction is suggested to represent e+-Mg elastic scattering and scattering parameters were derived to estimate the binding energy and annihilation rates. The trial function is taken to depend on several adjustable parameters and is improved iteratively by increasing the number of terms. The present results have the same behavior as reported semi-empirical, theoretical, and experimental results. Especially, the estimated positive scattering length supports the possibility of positron-magnesium bound state system that was confirmed in previous experimental and theoretical work.

Keywords: bound wavefunction, positron annihilation, scattering phase shift, scattering length

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Authors: Antonio Lopez-Villegas, Rafael Bautista-Mesa, Emilio Robles-Musso, Daniel Catalan-Matamoros, Cesar Leal-Costa

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Objectives: The purpose of this trial was to evaluate the burden borne by and the costs to informal caregivers of users with telemonitoring of pacemakers. Methods: This is a controlled, non-randomised clinical trial, with data collected from informal caregivers, five years after implantation of pacemakers. The Spanish version of the Survey on Disabilities, Personal Autonomy, and Dependency Situations was used to get information on clinical and social characteristics, levels of professionalism, duration and types of care, difficulties in providing care, health status, economic and job aspects, impact on the family or leisure due to informal caregiving for patients with pacemakers. Results: After five years of follow-up, 55 users with pacemakers finished the study. Of which, 50 were helped by a caregiver, 18 were included in the telemonitoring group (TM) and 32 in the conventional follow-up group (HM). Overall, females represented 96.0% of the informal caregivers (88.89% in TM and 100.0% in HM group). The mean ages were 63.17 ± 15.92 and 63.13 ± 14.56 years, respectively (p = 0.83) in the groups. The majority (88.0%) of the caregivers declared that they had to provide their services between 6 and 7 days per week (83.33% in TM group versus 90.63% in HM group), without significant differences between both groups. The costs related to care provided by the informal caregivers were 47.04% higher in the conventional follow-up group than in the TM group. Conclusions: The results of this trial confirm that there were no significant differences between the informal caregivers regarding to baseline characteristics, workload and time worked in both groups of follow-up. The costs incurred by the informal caregivers providing care for users with pacemakers included in telemonitoring group are significantly lower than those in the conventional follow-up group. Trial registration: ClinicalTrials.gov NCT02234245. Funding: The PONIENTE study, has been funded by the General Secretariat for Research, Development and Innovation, Regional Government of Andalusia (Spain), project reference number PI/0256/2017, under the research call 'Development and Innovation Projects in the Field of Biomedicine and Health Sciences', 2017.

Keywords: costs, disease burden, informal caregiving, pacemaker follow-up, remote monitoring, telemedicine

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Authors: Chao Hsing Yeh, Wei Chun Lin

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Background: Current management of aromatase inhibitor-induced arthralgia (AIA) in postmenopausal breast cancer survivors (PBCS) has limited effect. Method: In this prospective randomized clinical trial (RCT), a 4-week APA treatment was used to manage AIA. Twenty PBCS participated. After baseline data was collected, participants were waited for a month before they receive APA at a convenient time once a week for 4 weeks. Blood samples from participants in both groups were collected at baseline and after 4 weeks of treatment. The primary outcomes included: pain intensity, pain interference, stiffness, and physical function. Results: After the 4-week APA treatment, the pro-inflammatory cytokines and chemokines display a trend of mean percentage reduction (i.e., -22% in IL-1α, -4% in IL-1β, -1% in IL-2, -3% in IL-6, -19% in IL-12, -9% in Eotaxin, and -2% in MCP-1). The anti-inflammatory cytokine IL-10 and IL-13 (i.e., 5% in IL-10 and 29% in IL-13) increased from pre- to post-APA treatment. Significant positive correlation of percentage mean change was observed between symptom severity and eotaxin (ρ = 0.56; p < 0.01) & MCP-1 (ρ = 0.65; p < 0.01). Interference and chemokines (eotaxin & MIP-1) also shows positive correlation (ρ = 0.48; p < 0.01 & ρ = 0.39; p < 0.05). Another positive correlation was found between worst pain and chemokines (eotaxin, ρ = 0.48; p < 0.01 & MIP-1, ρ = 0.39; p < 0.05). Additionally, interference also shows positive correlation among IL-1α (ρ = 0.36; p < 0.05) and IL-β (ρ = 0.33; p < 0.05). Conclusion: These findings suggest that APA intervention may inhibit inflammation of AIA patients and chemokine could be one of the key factors of AIA symptom improvement.

Keywords: acupressure, cytokine, pain management, breast cancer survivors

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Authors: Maryam Zarra-Nezhad, Ali Moazami-Goodarzi, Joona Muotka, Nina Sajaniemi

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This study examines the extent to which the impact of a universal intervention program, i.e., POMPedaSens, on children’s early social-emotional learning (SEL) is different depending on early childhood education (ECE) teaches stress at work. The POMPedaSens program aims to promote children’s (5–6-year-olds) SEL by supporting ECE teachers’ engagement and emotional availability. The intervention effectiveness has been monitored using an 8-month randomized controlled trial design with an intervention (IG; 26 teachers and 195 children) and a waiting control group (CG; 36 teachers and 198 children) that provided the data before and after the program implementation. The ECE teachers in the IG are trained to implement the intervention program in their early childhood education and care groups. Latent change score analysis suggests that the program increases children’s prosocial behavior in the IG when teachers show a low level of stress. No significant results were found for the IG regarding a change in antisocial behavior. However, when teachers showed a high level of stress, an increase in prosocial behavior and a decrease in antisocial behavior were only found for children in the CG. The results suggest a promising application of the POMPedaSens program for promoting prosocial behavior in early childhood when teachers have low stress. The intervention will likely need a longer time to display the moderating effect of ECE teachers’ well-being on children’s antisocial behavior change.

Keywords: early childhood, social-emotional learning, universal intervention program, professional development, teachers' stress

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