Search results for: pain score

Authors: O. Casasayas, M. Vigo, R. Navarro, P. Ragazzi, P. Alvarez, A. Perez-Bellmunt

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Introduction: The blood flow restriction training (BFR) is a method of muscle training that allows increasing the stress of muscle tissue to enhance the muscle cross-section and strength. This type of training has clear benefits in the rehabilitation field since it can improve muscle strength using low mechanical loads. The aim of this study is to know in which knee pathologies BFR has been used, what methodology was used and what were the obtained results. Study design: We performed a systematic literature search using strategies for the concepts of “blood flow restriction OR blood flow restriction training AND knee” in Medline. Articles were screened by authors and included if they used the blood flow restriction training in pathology of the knee. Results: The pathology more frequently treated by BFR was knee osteoarthritis and the variables most analyzed were strength and pain. The vascular occlusion used was 80% in the major part of studies. The groups of BFR obtained an increase of strength with less pain but not always the results are statistically significant. The evidence levels are poor in the high number of studies because in some cases there is not a control group or the evaluators were not blinded. Conclusion: The use of BFR is useful to improve muscle strength in knee pathology since it does not increase the pain, but more studies are needed to see (comprehend) if this type of treatment obtains better results than a conventional therapy. No studies have been found that compare the different occlusion effects in both the strength improvement and the pain reduction. Neither studies that analyse the effects of BFR on the muscle contractile parameters have been found.

Keywords: blood flow restriction training, knee, arthroscopy knee, physical therapy

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Authors: Yusra Pintaningrum, Ilma Fahira Basyir, Sony Hilal Wicaksono, Vito A. Damay

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Background: Coronary artery calcium (CAC) scores play an important role in improving prognostic accuracy and can be selectively used to guide the allocation of statin therapy for atherosclerotic cardiovascular disease outcomes and potentially associated with the occurrence of MACE (Major Adverse Cardiovascular Event) and MI (Myocardial Infarction). Objective: This systematic review and meta-analysis aim to analyze the findings of a study about CAC Score and statin treatment effect on MI and MACE risk. Methods: Search for published scientific articles using the PRISMA (Preferred Reporting, Items for Systematic Reviews and Meta-Analysis) method conducted on PubMed, Cochrane Library, and Medline databases published in the last 20 years on “coronary artery calcium” AND “statin” AND “cardiovascular disease” Further systematic review and meta-analysis using RevMan version 5.4 were performed based on the included published scientific articles. Results: Based on 11 studies included with a total of 1055 participants, we performed a meta-analysis and found that individuals with CAC score > 0 increased risk ratio of MI 8.48 (RR = 9.48: 95% CI: 6.22 – 14.45) times and MACE 2.48 (RR = 3.48: 95% CI: 2.98 – 4.05) times higher than CAC score 0 individual. Statin compared against non-statin treatment showed a statistically insignificant overall effect on the risk of MI (P = 0.81) and MACE (P = 0.89) in an individual with elevated CAC score 1 – 100 (P = 0.65) and > 100 (P = 0.11). Conclusions: This study found that an elevated CAC scores individual has a higher risk of MI and MACE than a non-elevated CAC score individual. There is no significant effect of statin compared against non-statin treatment to reduce MI and MACE in elevated CAC score individuals of 1 – 100 or > 100.

Keywords: coronary artery calcium, statin, cardiovascular disease, myocardial infarction, MACE

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Authors: Ching-Yuan Chen, Lung-Kwang Pan

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Objective: Back pain is a major health problem costing billions of health budgets annually in Taiwan. Thousands of back pain surgeries are performed annually with up to 40% of patients complaining of back pain at time of post-surgery causing failed back surgery syndrome (FBSS), although diagnosis in these patients may be complex. The aim of study is to assess the feasibility of using bone SPECT-CT imaging to localize the active lesions causing persistent, recurrent or new backache after spine surgery. Materials and Methods: Bone SPECT-CT imaging was performed after the intravenous injection of 20 mCi of 99mTc-MDP for all the patients with diagnosis of FBSS. Patients were evaluated using status of subjectively pain relief, functional improvement and degree of satisfaction by reviewing the medical records and questionnaires in a 2 more years’ follow-up. Results: We enrolled a total of 16 patients were surveyed in our hospital from Jan. 2015 to Dec. 2016. Four people on SPEC/CT imaging ensured significant lesions were undergone a revised surgery (surgical treatment group). The mean visual analogue scale (VAS) decreased 5.3 points and mean Oswestry disability index (ODI) improved 38 points in the surgical group. The remaining 12 on SPECT/CT imaging were diagnosed as no significant lesions then received drug treatment (medical treatment group). The mean VAS only decreased 2 .1 point and mean ODI improved 12.6 points in the medical treatment group. In the posttherapeutic evaluation, the pain of the surgical treatment group showed a satisfactory improvement. In the medical treatment group, 10 of the 12 were also satisfied with the symptom relief while the other 2 did not improve significantly. Conclusions: Findings on SPECT-CT imaging appears to be easily explained the patients' pain. We recommended that SPECT/CT imaging was a feasible and useful clinical tool to improve diagnostic confidence or specificity when evaluating patients with FBSS.

Keywords: failed back surgery syndrome, oswestry disability index, SPECT-CT imaging, 99mTc-MDP, visual analogue scale

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Authors: Mohamed Aly, Aliaa Rehan Youssef, Emad Sawerees, Mounir Guirgis

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Relevance: Osteoarthritis (OA) is the most common degenerative disease seen in all populations. It causes disability and substantial socioeconomic burden. Evidence supports that exercise are the most effective conservative treatment for patients with OA. Therapists experience and clinical judgment play major role in exercise prescription and scientific evidence for this regard is lacking. The development of clinical prediction rules to identify patients who are most likely benefit from exercise may help solving this dilemma. Purpose: This study investigated whether body mass index and functional ability at baseline can predict patients’ response to a selected exercise program. Approach: Fifty-six patients, aged 35 to 65 years, completed an exercise program consisting of open kinetic chain strengthening and passive stretching exercises. The program was given for 3 sessions per week, 45 minutes per session, for 6 weeks Evaluation: At baseline and post treatment, pain severity was assessed using the numerical pain rating scale, whereas functional ability was being assessed by step test (ST), time up and go test (TUG) and 50 feet time walk test (50 FTW). After completing the program, global rate of change (GROC) score of greater than 4 was used to categorize patients as successful and non-successful. Thirty-eight patients (68%) had successful response to the intervention. Logistic regression showed that BMI and 50 FTW test were the only significant predictors. Based on the results, patients with BMI less than 34.71 kg/m2 and 50 FTW test less than 25.64 sec are 68% to 89% more likely to benefit from the exercise program. Conclusions: Clinicians should consider the described strengthening and flexibility exercise program for patents with BMI less than 34.7 Kg/m2 and 50 FTW faster than 25.6 seconds. The validity of these predictors should be investigated for other exercise.

Keywords: clinical prediction rule, knee osteoarthritis, physical therapy exercises, validity

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Authors: Sule Pallavi, Shah Priyank, Thavkar Amit, Mehta Suyog, Rohira Poonam

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Minoxidil is used topically to help hair growth in the treatment of male androgenetic alopecia. The objective of this study is to compare irritation potential of three conventional formulation of minoxidil 5% topical solution of in human patch test. The study was a single centre, double blind, non-randomized controlled study in 56 healthy adult Indian subjects. Occlusive patch test for 24 hours was performed with three formulation of minoxidil 5% topical solution. Products tested included aqueous based minoxidil 5% (AnasureTM 5%, Sun Pharma, India – Brand A), alcohol based minoxidil 5% (Brand B) and aqueous based minoxidil 5% (Brand C). Isotonic saline 0.9% and 1% w/w sodium lauryl sulphate were included as negative control and positive control respectively. Patches were applied and removed after 24hours. The skin reaction was assessed and clinically scored 24 hours after the removal of the patches under constant artificial daylight source using Draize scale (0-4 points scale for erythema/wrinkles/dryness and for oedema). A combined mean score up to 2.0/8.0 indicates a product is “non-irritant” and score between 2.0/8.0 and 4.0/8.0 indicates “mildly irritant” and score above 4.0/8.0 indicates “irritant”. Follow-up was scheduled after one week to confirm recovery for any reaction. The procedure of the patch test followed the principles outlined by Bureau of Indian standards (BIS) (IS 4011:2018; Methods of Test for safety evaluation of Cosmetics-3rd revision). Fifty six subjects with mean age 30.9 years (27 males and 29 females) participated in the study. The combined mean score (± standard deviation) were: 0.13 ± 0.33 (Brand A), 0.39 ± 0.49 (Brand B), 0.22 ± 0.41 (Brand C), 2.91 ± 0.79 (Positive control) and 0.02 ± 0.13 (Negative control). The mean score of Brand A (Sun Pharma product) was significantly lower than Brand B (p=0.001) and was comparable with Brand C (p=0.21). The combined mean erythema score (± standard deviation) were: 0.09 ± 0.29 (Brand A), 0.27 ± 0.5 (Brand B), 0.18 ± 0.39 (Brand C), 2.02 ± 0.49 (Positive control) and 0.0 ± 0.0 (Negative control). The mean erythema score of Brand A was significantly lower than Brand B (p=0.01) and was comparable with Brand C (p=0.16). Any reaction observed at 24hours after patch removal subsided in a week. All the three topical formulation of minoxidil 5% were non-irritant. Brand A of 5% minoxidil (Sun Pharma) was found to be least irritant than Brand B and Brand C based on the combined mean score and mean erythema score in the human patch test as per the BIS, IS 4011;2018.

Keywords: erythema, irritation, minoxidil, patch test

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Authors: Khandoker Akib Mohammad

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While analyzing time-to-event data, it is possible that a certain fraction of subjects will never experience the event of interest, and they are said to be cured. When this feature of survival models is taken into account, the models are commonly referred to as cure models. In the presence of covariates, the conditional survival function of the population can be modelled by using the cure model, which depends on the probability of being uncured (incidence) and the conditional survival function of the uncured subjects (latency), and a combination of logistic regression and Cox proportional hazards (PH) regression is used to model the incidence and latency respectively. In this paper, we have shown the asymptotic normality of the profile likelihood estimator via asymptotic expansion of the profile likelihood and obtain the explicit form of the variance estimator with an implicit function in the profile likelihood. We have also shown the efficient score function based on projection theory and the profile likelihood score function are equal. Our contribution in this paper is that we have expressed the efficient information matrix as the variance of the profile likelihood score function. A simulation study suggests that the estimated standard errors from bootstrap samples (SMCURE package) and the profile likelihood score function (our approach) are providing similar and comparable results. The numerical result of our proposed method is also shown by using the melanoma data from SMCURE R-package, and we compare the results with the output obtained from the SMCURE package.

Keywords: Cox PH model, cure model, efficient score function, EM algorithm, implicit function, profile likelihood

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Authors: Helena Costa Oliveira, Carmem Oliveira, Rita Moutinho

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The Balanced Scorecard (BSC) is a continuous strategic monitoring model focused not only on financial issues but also on internal processes, patients/users, and learning and growth. Initially dedicated to business management, it currently serves organizations of other natures - such as hospitals. This paper presents a BSC designed for a Portuguese Acute Pain Unit (APU). This study is qualitative and based on the experience of collaborators at the APU. The management of APU is based on four perspectives – users, internal processes, learning and growth, and financial and legal. For each perspective, there were identified strategic objectives, critical factors, lead indicators and initiatives. The strategic map of the APU outlining sustained strategic relations among strategic objectives. This study contributes to the development of research in the health management area as it explores how organizational insufficiencies and inconsistencies in this particular case can be addressed, through the identification of critical factors, to clearly establish core outcomes and initiatives to set up.

Keywords: acute pain unit, balanced scorecard, hospital management, organizational performance, Portugal

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Authors: Nursyafiq Ali Shibramulisi, Nor Farah Fauzi, Nur Azniza Zawin Anuar, Nurul Atikah Azmi, Janice Hew Pei Fang

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Background: Work related musculoskeletal disorders (WRMD) among dental personnel have been underestimated and under-reported worldwide and specifically in Malaysia. The problem will arise and progress slowly over time, as it results from accumulated injury throughout the period of work. Several risk factors, such as repetitive movement, static posture, vibration, and adapting poor working postures, have been identified to be contributing to WRMSD in dental practices. Dental personnel is at higher risk of getting this problem as it is their working nature and core business. This would cause pain and dysfunction syndrome among them and result in absence from work and substandard services to their patients. Methodology: A cross-sectional study involving 19 government dental clinics in Perak was done over the period of 3 months. Those who met the criteria were selected to participate in this study. Malay version of the Self-Reported Nordic Musculoskeletal Discomfort Form was used to identify the prevalence of WRMSD, while the intensity of pain in the respective regions was evaluated using a 10-point scale according to ‘Pain as The 5ᵗʰ Vital Sign’ by MOH Malaysia and later on were analyzed using SPSS version 25. Descriptive statistics, including mean and SD and median and IQR, were used for numerical data. Categorical data were described by percentage. Pearson’s Chi-Square Test and Spearman’s Correlation were used to find the association between the prevalence of WRMSD and other socio-demographic data. Results: 159 dentists, 73 dental therapists, 26 dental lab technicians, 81 dental surgery assistants, and 23 dental attendants participated in this study. The mean age for the participants was 34.9±7.4 and their mean years of service was 9.97±7.5. Most of them were female (78.5%), Malay (71.3%), married (69.6%) and right-handed (90.1%). The highest prevalence of WRMSD was neck (58.0%), followed by shoulder (48.1%), upper back (42.0%), lower back (40.6%), hand/wrist (31.5%), feet (21.3%), knee (12.2%), thigh 7.7%) and lastly elbow (6.9%). Most of those who reported having neck pain scaled their pain experiences at 2 out of 10 (19.5%), while for those who suffered upper back discomfort, most of them scaled their pain experience at 6 out of 10 (17.8%). It was found that there was a significant relationship between age and pain at neck (p=0.007), elbow (p=0.027), lower back (p=0.032), thigh (p=0.039), knee (p=0.001) and feet (p=0.000) regions. Job position also had been found to be having a significant relationship with pain experienced at the lower back (p=0.018), thigh (p=0.011), knee, and feet (p=0.000). Conclusion: The prevalence of WRMSD among dental personnel in Perak was found to be high. Age and job position were found to be having a significant relationship with pain experienced in several regions. Intervention programs should be planned and conducted to prevent and reduce the occurrence of WRMSD, as all harmful or unergonomic practices should be avoided at all costs.

Keywords: WRMSD, ergonomic, dentistry, dental

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Authors: Münevver Başman, Ezel Tavşancıl

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Making the right decisions about students depends on teachers’ use of the assessment and evaluation techniques effectively. In order to do that, teachers should have positive attitudes and adequate self-efficacy perception towards assessment and evaluation. The purpose of this study is to investigate relationship between self-efficacy perception and the attitudes of prospective teachers towards assessment and evaluation and what kind of differences these issues have in terms of a variety of demographic variables. The study group consisted of 277 prospective teachers who have been studying in different departments of Marmara University, Faculty of Education. In this study, ‘Personal Information Form’, ‘A Perceptual Scale for Measurement and Evaluation of Prospective Teachers Self-Efficacy in Education’ and ‘Attitudes toward Educational Measurement Inventory’ are applied. As a result, positive correlation was found between self-efficacy perceptions and the attitudes of prospective teachers towards assessment and evaluation. Considering different departments, there is a significant difference between the mean score of attitudes of prospective teachers and between the mean score of self-efficacy perceptions of them. However, considering variables of attending statistics class and the class types at the graduated high school, there is no significant difference between the mean score of attitudes of prospective teachers and between the mean score of self-efficacy perceptions of them.

Keywords: attitude, perception, prospective teacher, self-efficacy

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Authors: Anna Mucha, Ewa Wojtyna, Anita Pollak

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The environment in which an individual resides and observes may play a meaningful role in well-being and related constructs. Contact with nature may have a positive influence of natural environments on individuals, impacting mood and psychophysical sensations, such as pain relief. Conversely, urban settings, dominated by concrete elements, might lead to mood decline and heightened stress levels. Similarly, the situation may appear in the case of the perception of virtual environments. However, this is a topic that requires further exploration, especially in the context of relationships with pain. The aforementioned matters served as the basis for formulating and executing the outlined experimental research within the realm of environmental psychology, leveraging new technologies, notably virtual reality (VR), which is progressively gaining prominence in the domain of mental health. The primary objective was to investigate the impact of a simulated virtual environment, mirroring a natural setting abundant in greenery, on the perception of acute pain induced by thermal stimuli (high temperature) – encompassing intensity, unpleasantness, and pain tolerance. Comparative analyses were conducted between the virtual natural environment (intentionally constructed in the likeness of a therapeutic garden), virtual urban environment, and a control group devoid of virtual projections. Secondary objectives aimed to determine the mutual relationships among variables such as positive and negative emotions, preferences regarding virtual environments, sense of presence, and restorative experience in the context of the perception of presented virtual environments and induced thermal pain. The study encompassed 126 physically healthy Polish adults, distributing 42 individuals across each of the three comparative groups. Oculus Rift VR technology and the TSA-II neurosensory analyzer facilitated the experiment. Alongside demographic data, participants' subjective feelings concerning virtual reality and pain were evaluated using the Visual Analogue Scale (VAS), the original Restorative Experience in the Virtual World questionnaire (Doświadczenie Regeneracji w Wirtualnym Świecie), and an adapted Slater-Usoh-Steed (SUS) questionnaire. Results of statistical and psychometric analyses, such as Kruskal-Wallis tests, Wilcoxon tests, and contrast analyses, underscored the positive impact of the virtual natural environment on individual pain perception and mood. The virtual natural environment outperformed the virtual urban environment and the control group without virtual projection, particularly in subjective pain components like intensity and unpleasantness. Variables such as restorative experience, sense of presence and virtual environment preference also proved pivotal in pain perception and pain tolerance threshold alterations, contingent on specific conditions. This implies considerable application potential for virtual natural environments across diverse realms of psychology and related fields, among others as a supportive analgesic approach and a form of relaxation following psychotherapeutic sessions.

Keywords: environmental psychology, nature, acute pain, emotions, vitrual reality, virtual environments

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Authors: Arfaoui Emna, Nouira Mariem

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Background and aims: Breastfeeding is the reference feeding for a child, especially during the first months of life. It is not widespread in many countries due to many factors. There has been a decline in exclusive breastfeeding (EB) practice, particularly in the middle- and low-income countries, i.e., Tunisia. The aim of our study was to describe the knowledge, attitudes, and practice of a sample of Tunisian mothers toward breastfeeding. Methods: It was a descriptive cross-sectional study conducted during the year 2022 over a period of two months in three health structures in the north of Tunisia among mothers of infants aged 2 to 18 months. Levels of mothers’ knowledge (low/moderate/high) were determined using a score ranging from 0 to 11 points. EB was defined as the proportion of infants who were exclusively breastfed during the first six months of life. Results: A total of 180 women with a mean age of 33±4.9 years were included. The average knowledge score was equal to 6.4 ±1.5 points, with extremes ranging from 3 to 11 points. Most of the respondents had a moderate knowledge level (44.4%). More than half of surveyed mothers (66.1%) thought that breastfeeding deforms breasts, and 16.7% thought that breastfeeding is specific to women who do not work. Breastfeeding experience during the first week of life was considered difficult in 70% of cases. The prevalence of EB up to 6 months of age was equal to 16.4% [10.8-23.2]. The main reported obstacles during breastfeeding practice were having an insufficient quantity of breast milk (18.3%) and child difficulties with sucking (12.8%), and having pain in the breast while breastfeeding (12.80%). Conclusion: Our results highlighted the insufficient level of knowledge and a low prevalence of EB in our study population. Improving mothers’ knowledge and promoting EB practice is needed. Implementing health education strategies involving healthcare workers, who represent a main actor in education and breastfeeding promotion, is very important to reach a satisfactory frequency for EB.

Keywords: breastfeeding, practices, knowledge, Tunisia

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Authors: Hossam N. Alhawatmeh, Areen I. Albustanji

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Hemodialysis negatively affects physical and psychological health. Pain, poor sleep quality, and low self-esteem are highly prevalent among patients with end-stage renal disease (ESRD) who receive hemodialysis, significantly increasing mortality and morbidity of those patients. Mind-body interventions (MBI), such as mindfulness meditation, have been recently gaining popularity that improved pain, sleep quality, and self-esteem in different populations. However, to our best knowledge, its effects on these health problems in patients receiving hemodialysis have not been studied in Jordan. Thus, the purpose of the study was to examine the effect of mindfulness meditation on pain, sleep quality, and self-esteem in patients with ESR receiving hemodialysis in Jordan. An experimental repeated-measures, randomized, parallel control design was conducted on (n =60) end-stage renal disease patients undergoing hemodialysis between March and June 2023 in the dialysis center at a public hospital in Jordan. Participants were randomly assigned to the experimental (n =30) and control groups (n =30) using a simple random assignment method. The experimental group practiced mindfulness meditation for 30 minutes three times per week for five weeks during their hemodialysis treatments. The control group's patients continued to receive hemodialysis treatment as usual for five weeks during hemodialysis sessions. The study variables for both groups were measured at baseline (Time 0), two weeks after intervention (Time 1), and at the end of intervention (Time 3). The numerical rating scale (NRS), the Rosenberg Self-Esteem Scale (RSES-M), and the Pittsburgh Sleep Quality Index (PSQI) were used to measure pain, self-esteem, and sleep quality, respectively. SPSS version 25 was used to analyze the study data. The sample was described by frequency, mean, and standard deviation as an appropriate. The repeated measures analysis of variance (ANOVA) tests were run to test the study hypotheses. The results of repeated measures ANOVA (within-subject) revealed that mindfulness meditation significantly decrease pain by the end of the intervention in the experimental group. Additionally, mindfulness meditation improved sleep quality and self-esteem in the experimental group, and these improvements occurred significantly after two weeks of the intervention and at the end of the intervention. The results of repeated measures ANOVA (within and between-subject) revealed that the experimental group, compared to the control group, experienced lower levels of pain and higher levels of sleep quality and self-esteem over time. In conclusion, the results provided substantial evidence supporting the positive impacts of mindfulness meditation on pain, sleep quality, and self-esteem in patients with ESRD undergoing hemodialysis. These results highlight the potential of mindfulness meditation as an adjunctive therapy in the comprehensive care of this patient population. Incorporating mindfulness meditation into the treatment plan for patients receiving hemodialysis may contribute to improved well-being and overall quality of life.

Keywords: hemodialysis, pain, sleep quality, self-esteem, mindfulness

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Authors: Augustine Ndudi Egere, Shehu Adamu, Esther Ishaya Solomon

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As internet accessibility and smartphones continue to increase in Nigeria, Africa’s most populous country, social media platforms have become ubiquitous, causing students of 18-25 age brackets to spend more time on social media. The research investigated the impact of prolonged social media use on the physical health of students, with a specific focus on computer vision syndrome, hand pain, headaches and mental status. The study adopted a mixed-methods approach combining quantitative surveys to gather statistical data on usage patterns and symptoms, along with qualitative interviews into the experiences and perceptions of medical practitioners concerning cases under study within the geopolitical region. The result was analyzed using Regression analysis. It was observed that there is a significant correlation between social media usage by the students in the study age bracket concerning computer vision syndrome, hand pain, headache and general mental status. The research concluded by providing valuable insights into potential interventions and strategies to mitigate the adverse effects of excessive social media use on student well-being and recommends, among others, that educational institutions, parents, and students themselves collaborate to implement strategies aimed at promoting responsible and balanced use of social media.

Keywords: social media, student health, computer vision syndrome, hand pain, headaches, mental staus

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Authors: Ayu Nabila Kusuma Pradana, Aprinaldi Jasa Mantau, Tomohiko Akahoshi

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The incidence of Disseminated intravascular coagulation (DIC) following gastrointestinal surgery has a poor prognosis. Therefore, it is important to determine the factors that can predict the prognosis of DIC. This study will investigate the factors that may influence the outcome of DIC in patients after gastrointestinal surgery. Eighty-one patients were admitted to the intensive care unit after gastrointestinal surgery in Kyushu University Hospital from 2003 to 2021. Acute DIC scores were estimated using the new Japanese Association for Acute Medicine (JAAM) score from before and after surgery from day 1, day 3, and day 7. Acute DIC scores will be compared with The Sequential Organ Failure Assessment (SOFA) score, platelet count, lactate level, and a variety of biochemical parameters. This study applied machine learning algorithms to predict the prognosis of DIC after gastrointestinal surgery. The results of this study are expected to be used as an indicator for evaluating patient prognosis so that it can increase life expectancy and reduce mortality from cases of DIC patients after gastrointestinal surgery.

Keywords: the survival rate, gastrointestinal surgery, JAAM score, neural network, machine learning, disseminated intravascular coagulation (DIC)

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Authors: R. Suresh, C. B. Singh, A. K. Sarda

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Background: Over the decades, several surgical techniques have been developed to treat anal fistulas with variable success rates and complications. Large amount of work has been done in radiofrequency excision of the fistula for several years but no work has been done for ablating the tract. Therefore one can consider for obliteration ofanal fistula by Radiofrequency ablation (RFA). Material and Methods: A randomized controlled clinical trial was conducted at Lok Nayak Hospital, where a total of 40 patients were enrolled in the study and they were randomly assigned to Group I (fistulectomy)(n=20) and Group II (RFA) (n=20). Aim of the study was to compare the efficacy of RFA of fistula versus fistulectomy in the treatment of a low anal fistula and to evaluate RFA as an effective alternative to fistulectomy with respect to time taken for wound healing as primary outcome and post-operative pain, time taken to return to work as secondary outcomes. Patients with simple low anal fistulas, single internal and external opening, not more than two secondary tracts were included. Patients with high complex fistula, fistulas communicating with cavity, fistula due to condition like tuberculosis, Crohn's, malignancy were excluded from the study. Results: Both groups were comparable with respect to age, sex ratio, type of fistula. Themean healing time was significantly shorter in group II (41.02 days) than in group I(62.68 days).The mean operative time was significantly shorter in groupII (21.40 min) than in group I(28.50 min). The mean time taken to return to work was significantly shorter in group II(8.30 days)than in group I(12.01 days).There was no significant difference in the post operative hospital stay, mean postoperative pain score, wound infection and recurrence between the two groups. Conclusion: The patients who underwent RFA of fistula had shorter wound healing time, operative time and time taken to return to work when compared to those who underwent fistulectomy and therefore RFA shows outcome comparable to fistulectomy in the treatment of low anal fistula.

Keywords: fistulectomy, low anal fistula, radio frequency ablation, wound healing

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Authors: Junaid Hamid Bhat

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Background: Musculoskeletal disorders are one of the main causes of occupational illness. Mechanisms and the factors like repetitive work, physical effort and posture, endangering the risk of musculoskeletal disorders would now appear to have been properly identified. Teacher’s exposure to work-related musculoskeletal disorders appears to be insufficiently described in the literature. Little research has investigated the prevalence and risk factors of musculoskeletal disorders in teaching profession. Very few studies are available in this regard and there are no studies evident in India. Purpose: To determine the prevalence of musculoskeletal disorders and to identify and measure the association of such risk factors responsible for developing musculoskeletal disorders among school teachers. Methodology: An observational cross sectional study was carried out. 500 school teachers from primary, middle, high and secondary schools were selected, based on eligibility criteria. A signed consent was obtained and a self-administered, validated questionnaire was used. Descriptive statistics was used to compute the statistical mean and standard deviation, frequency and percentage to estimate the prevalence of musculoskeletal disorders among school teachers. The data analysis was done by using SPSS version 16.0. Results: Results indicated higher pain prevalence (99.6%) among school teachers during the past 12 months. Neck pain (66.1%), low back pain (61.8%) and knee pain (32.0%) were the most prevalent musculoskeletal complaints of the subjects. Prevalence of shoulder pain was also found to be high among school teachers (25.9%). 52.0% subjects reported pain as disabling in nature, causing sleep disturbance (44.8%) and pain was found to be associated with work (87.5%). A significant association was found between musculoskeletal disorders and sick leaves/absenteeism. Conclusion: Work-related musculoskeletal disorders particularly neck pain, low back pain, and knee pain, is highly prevalent and risk factors are responsible for the development of same in school teachers. There is little awareness of musculoskeletal disorders among school teachers, due to work load and prolonged/static postures. Further research should concentrate on specific risk factors like repetitive movements, psychological stress, and ergonomic factors and should be carried out all over the country and the school teachers should be studied carefully over a period of time. Also, an ergonomic investigation is needed to decrease the work-related musculoskeletal disorder problems. Implication: Recall bias and self-reporting can be considered as limitations. Also, cause and effect inferences cannot be ascertained. Based on these results, it is important to disseminate general recommendations for prevention of work-related musculoskeletal disorders with regards to the suitability of furniture, equipment and work tools, environmental conditions, work organization and rest time to school teachers. School teachers in the early stage of their careers should try to adapt the ergonomically favorable position whilst performing their work for a safe and healthy life later. Employers should be educated on practical aspects of prevention to reduce musculoskeletal disorders, since changes in workplace and work organization and physical/recreational activities are required.

Keywords: work related musculoskeletal disorders, school teachers, risk factors funding, medical and health sciences

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Authors: Nantawan Soonklang, Linda Chularojanamontri, Urarat Nanna

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Ethnopharmacological relevance: Thunbergia laurifolia Lindl. belongs to the family Acanthaceae commonly known as Rang jeud in Thailand. This plant is traditionally used in Thailand for centuries as an antidote for several poisons and drug overdose. Aim of the study: This research aimed to study the analgesic and antipyretic activities of T. laurifolia water extract by using animal models. Materials and Methods: The analgesic activity was studied using 2 methods of pain induction including acetic acid and heat induced pain. And the antipyretic activity study was performed by yeast-induced hyperthermia. Results: The results showed that the administration of T. laurifolia extract possessed analgesic activity by reducing acetic acid-induced writhing response and heat-induced pain as well as showed antipyretic activity by decreasing body temperature of hyperthermic rats induced by brewer’s yeast. Conclusion: The study indicates that the T. laurifolia extract possesses analgesic and antipyretic activities in animals.

Keywords: Thunbergia laurifolia extract, analgesic activity, antipyretic activity, hyperthermia

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Authors: Linda P. M. Pluymen, Mariska M. G. Leeflang, I. Stegeman, Henock G. Yebyo, Anne E. M. Brabers, Patrick M. Bossuyt, E. Dekker, Anke J. Woudstra, Mirjam P. Fransen

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Weighing the benefits and harms of colorectal cancer screening can be difficult for individuals. An existing online decision aid was expanded with a benefit-harm analysis to help people make an informed decision about participating in colorectal cancer screening. In a randomized controlled trial, we investigated whether those in the intervention group who used the decision aid with benefit-harm analysis were more certain about their decision than those in the control group who used the decision aid without benefit-harm analysis. Participants were 623 (39% of those invited) men and women aged 45 until 75 years old. Analyses were performed in those 386 participants (62%) who reported to have completed the entire decision aid. No statistically significant differences were observed between intervention and control group in decisional conflict score (mean difference 2.4, 95% CI -0.9, 5.6), clarity of values (mean difference 1.0, 95% CI -4.4, 6.6), deliberation score (mean difference 0.5, 95% CI -0.6, 1.7), anxiety score (mean difference 0.0, 95% CI -0.3, 0.3) and risk perception score (mean difference 0.1, -0.1, 0.3). Adding a benefit-harm analysis to an online decision aid did not improve informed decision making about participating in colorectal cancer screening.

Keywords: benefit-harm analysis, decision aid, informed decision making, personalized decision making

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Authors: Geum Yeon Sim, Tyler Pigott, Julio Vasquez

Abstract:

A 38-year-old obese female with no apparent past medical history presented with left knee pain. Six months ago, she sustained a left knee dislocation in a motor vehicle accident that was managed with a skin graft over the left lower extremity without any reconstructive surgery. She developed persistent pain and stiffness in her left knee that worsened with walking and stair climbing. Examination revealed healed extensive skin graft over the left lower extremity, including the left knee. Palpation showed moderate tenderness along the superior border of the patella, exquisite tenderness over MCL, and mild tenderness on the tibial tuberosity. There was normal sensation, reflexes, and strength in her lower extremities. There was limited active and passive range of motion of her left knee during flexion. There was instability noted upon the valgus stress test of the left knee. Left knee magnetic resonance imaging showed high-grade (grade 2-3) injury of the proximal superficial fibers of the MCL and diffuse thickening and signal abnormality of the cruciate ligaments, as well as edema-like subchondral marrow signal change in the anterolateral aspect of the lateral femoral condyle weight-bearing surface. There was also notable extensive scarring and edema of the skin, subcutaneous soft tissues, and musculature surrounding the knee. The patient was managed with left knee immobilization for five months, which was complicated by limited knee flexion. Physical therapy consisting of quadriceps, hamstrings, gastrocnemius stretching and strengthening, range of motion exercises, scar/soft tissue mobilization, and gait training was given with marked improvement in pain and range of motion. The patient experienced a further reduction in pain as well as an improvement in function with home exercises consisting of continued strengthening and stretching.

Keywords: ligamentous injury, trauma, rehabilitation, knee pain

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Authors: Hosam Alzahrani, Martin Mackey, Emmanuel Stamatakis, Marina B. Pinheiro, Manuela Wicks, Debra Shirley

Abstract:

Objective: To investigate the effectiveness of incidental (non-structured) physical activity interventions compared with other commonly prescribed interventions for the management of people with low back pain (LBP). Methods: We performed a systematic review with meta-analyses of eligible randomized controlled trials obtained by searching Medline, Scopus, CINAHL, EMBASE, and CENTRAL. This review considered trials investigating the effect of incidental physical activity interventions compared to other interventions in people aged 18 years or over, diagnosed with non-specific LBP. Analyses were conducted separately for short-term (≤3 months), intermediate-term (> 3 and < 12 months), and long-term (≥ 12 months), for each outcome. The analyses were conducted using the weighted mean difference (WMD). The overall quality of evidence was assessed using the GRADE system. Meta-analyses were only performed for pain and disability outcomes as there was insufficient data on the other outcomes. Results: For pain, the pooled results did not show any significant effects between the incidental physical activity intervention and other interventions at any time point. For disability, incidental physical activity was not statistically more effective than other interventions at short-term; however, the pooled results favored incidental physical activity at intermediate-term (WMD= -6.05, 95% CI: -10.39 to -1.71, p=0.006) and long-term (WMD= -6.40 95% CI: -11.68 to -1.12, p=0.02) follow-ups among participants with chronic LBP. The overall quality of evidence was rated “moderate quality” based on the GRADE system. Conclusion: The incidental physical activity intervention provided intermediate and long disability relief for people with chronic LBP, although this improvement was small and not likely to be clinically important.

Keywords: physical activity, incidental, low back pain, systematic review, meta-analysis

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Authors: Joshi Rajiv, Shah Priyank, Thavkar Amit, Rohira Poonam, Mehta Suyog

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Topical formulation containing minoxidil and finasteride helps hair growth in the treatment of male androgenetic alopecia. The objective of this study is to compare the irritation potential of three conventional formulations of minoxidil 5% + finasteride 0.1% topical solution of in human patch test. The study was a single centre, double blind, non-randomized controlled study in 53 healthy adult Indian subjects. Occlusive patch test for 24 hours was performed with three formulations of minoxidil 5% + finasteride 0.1% topical solution. Products tested included aqueous based minoxidil 5% + finasteride 0.1% (AnasureTM-F, Sun Pharma, India – Brand A), lipid based minoxidil 5% + finasteride 0.1% (Brand B) and aqueous based minoxidil 5% + finasteride 0.1% (Brand C). Isotonic saline 0.9% and 1% w/w sodium lauryl sulphate were included as negative control and positive control respectively. Patches were applied and removed after 24 hours. The skin reaction was assessed and clinically scored 24 hours after the removal of the patches under constant artificial daylight source using the Draize scale (0-4 points scale for erythema/dryness//wrinkles and for oedema). Follow-up was scheduled after one week to confirm recovery for any reaction. A combined mean score up to 2.0/8.0 indicates a product is “non-irritant” and a score between 2.0/8.0 and 4.0/8.0 indicates “mildly irritant” and a score above 4.0/8.0 indicates “irritant”. The procedure of the patch test followed the principles outlined by the Bureau of Indian Standards (BIS) (IS 4011:2018; Methods of Test for safety evaluation of Cosmetics-3rd revision). Fifty three subjects with mean age 31.9 years (25 males and 28 females) participated in the study. The combined mean score ± standard deviation were: 0.06 ± 0.23 (Brand A), 0.81 ± 0.59 (Brand B), 0.38 ± 0.49 (Brand C), 2.92 ± 0.47 (positive control) and 0.0 ± 0.0 (Negative control). This means the score of Brand A (Sun Pharma product) was significantly lower than that of Brand B (p=0.001) and that of Brand C (p=0.001). The combined mean erythema score ± standard deviation were: 0.06 ± 0.23 (Brand A), 0.81 ± 0.59 (Brand B), 0.38 ± 0.49 (Brand C), 2.09 ± 0.4 (Positive control) and 0.0 ± 0.0 (Negative control). The mean erythema score of Brand A was significantly lower than Brand B (p=0.001) and that of Brand C (p=0.001). Any reaction observed at 24hours after patch removal subsided in a week. All the three topical formulations of minoxidil 5% + finasteride 0.1% were non-irritant. Brand A of minoxidil 5% + finasteride 0.1% (Sun Pharma) was found to be the least irritant than Brand B and Brand C based on the combined mean score and mean erythema score in the human patch test as per the BIS, IS 4011:2018

Keywords: erythema, finasteride, irritation, minoxidil, patch test

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Authors: Dylan Treger, Lujia Zhang, Xiaoxiao Jia, Jessica H. Hui, Munkh-Amgalan Gantumur, Mizhou Hui, Li Liu

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Hyaluronic acid (HA) is involved in wound healing via inflammation, granulation, and re-epithelialization mechanisms. The poor physical properties of natural high-molecular-weight polymers limit their direct use in the medical field. In this clinical study, we investigated whether the local injection of a tissue-permeable 35 kDa HA fragment (HA35) could favor the healing process in patients with chronic wounds accompanied by neuropathic pain. The HA35 fragments were freshly manufactured by degradation of high-molecular-weight HA with bovine testis-derived hyaluronidase PH20. Twenty patients in this study had nonhealing wounds and wound-related pain for more than 3 months. Freshly produced HA35 was locally injected into healthy skin immediately surrounding chronic wounds once a day for 10 days. Wound-associated pain and the degree of wound healing were evaluated. The injection of HA35 relieved the pain associated with chronic wounds in 24 hours. HA35 treatment significantly promoted the healing of chronic wounds, including expanded fresh granulation tissue on the wounds; reduced darkness or redness, dryness, and damaged areas on the surface of the skin surrounding the wounds; and decreased the size of the wound area. It can be concluded that the topical injection of tissue-permeable HA35 around chronic wounds has great potential to promote wound healing.

Keywords: 35 kDa hyaluronan fragment HA35, chronic wound, wound healing, tissue permeability

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Authors: Denisa Mackova, Andrea Pokorna

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The management of postoperative pain is a meaningful part of quality care. The experience and knowledge of registered nurses in postoperative pain management can be influenced by local know-how. Therefore, the research helps to understand the cultural differences between two countries with the aim of evaluating the management of postoperative pain management among the nurses from the Czech Republic and the Kingdom of Saudi Arabia. Both countries have different procedures on managing postoperative pain and the research will provide an understanding of both the advantages and disadvantages of the procedures and also highlight the knowledge and experience of registered nurses in both countries. Between the Czech Republic and the Kingdom of Saudi Arabia, the expectation is for differing results in the usage of opioid analgesia for the patients postoperatively and in the experience of registered nurses with Patient Controlled Analgesia. The aim is to evaluate the knowledge and awareness of registered nurses and to merge the data with the postoperative pain management in the early postoperative period in the Czech Republic and the Kingdom of Saudi Arabia. Also, the aim is to assess the knowledge and experience of registered nurses by using Patient Controlled Analgesia and epidural analgesia treatment in the early postoperative period. The criteria for those providing input into the study, are registered nurses, working in surgical settings (standard departments, post-anesthesia care unit, day care surgery or ICU’s) caring for patients in the postoperative period. Method: Research is being conducted by questionnaires. It is a quantitative research, a comparative study of registered nurses in the Czech Republic and the Kingdom of Saudi Arabia. Questionnaire surveys were distributed through an electronic Bristol online survey. Results: The collection of the data in the Kingdom of Saudi Arabia has been completed successfully, with 550 respondents, 77 were excluded and 473 respondents were included for statistical data analysis. The outcome of the research is expected to highlight the differences in treatment through Patient Controlled Analgesia, with more frequent use in the Kingdom of Saudi Arabia. A similar assumption is expected for treatment conducted by analgesia. We predict that opioids will be used more regularly in the Kingdom of Saudi Arabia, whilst therapy through NSAID’s being the most common approach in the Czech Republic. Discussion/Conclusion: The majority of respondents from the Kingdom of Saudi Arabia were female registered nurses from a multitude of nations. We are expecting a similar split in gender between the Czech Republic respondents; however, there will be a smaller number of nationalities. Relevance for research and practice: Output from the research will assess the knowledge, experience and practice of patient controlled analgesia and epidural analgesia treatment. Acknowledgement: This research was accepted and affiliated to the project: Postoperative pain management, knowledge and experience registered nurses (Czech Republic and Kingdom of Saudi Arabia) – SGS05/2019-2020.

Keywords: acute postoperative pain, epidural analgesia, nursing care, patient controlled analgesia

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Authors: Justin Durham, Chanda Rooney, Robert Mather, Mickie Vanhoy

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The psychological construct of empathy is to understand a person’s cognitive perspective and experience the other person’s emotional state. Deciphering emotional states is conducive for interpreting vicarious pain. Observing others' physical pain activates neural networks related to the actual experience of pain itself. The study addresses empathy as a nonlinear dynamic process of simulation for individuals to understand the mental states of others and experience vicarious pain, exhibiting self-organized criticality. Such criticality follows from a combination of neural networks with an excitatory feedback loop generating bistability to resonate permutated empathy. Cortical networks exhibit diverse patterns of activity, including oscillations, synchrony and waves, however, the temporal dynamics of neurophysiological activities underlying empathic processes remain poorly understood. Mu rhythms are EEG oscillations with dominant frequencies of 8-13 Hz becoming synchronized when the body is relaxed with eyes open and when the sensorimotor system is in idle, thus, mu rhythm synchrony is expected to be highest in baseline conditions. When the sensorimotor system is activated either by performing or simulating action, mu rhythms become suppressed or desynchronize, thus, should be suppressed while observing video clips of painful injuries if previous research on mirror system activation holds. Twelve undergraduates contributed EEG data and survey responses to empathy and psychopathy scales in addition to watching consecutive video clips of sports injuries. Participants watched a blank, black image on a computer monitor before and after observing a video of consecutive sports injuries incidents. Each video condition lasted five-minutes long. A BIOPAC MP150 recorded EEG signals from sensorimotor and thalamocortical regions related to a complex neural network called the ‘pain matrix’. Physical and social pain are activated in this network to resonate vicarious pain responses to processing empathy. Five EEG single electrode locations were applied to regions measuring sensorimotor electrical activity in microvolts (μV) to monitor mu rhythms. EEG signals were sampled at a rate of 200 Hz. Mu rhythm desynchronization was measured via 8-13 Hz at electrode sites (F3 & F4). Data for each participant’s mu rhythms were analyzed via Fast Fourier Transformation (FFT) and multifractal time series analysis.

Keywords: desynchronization, dynamical systems theory, electroencephalography (EEG), empathy, multifractal time series analysis, mu waveform, neurophysiology, pain simulation, social cognition

Procedia PDF Downloads 266

Authors: Bechir Hbibi, Lamine Mili

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Understanding the condition of comatose patients can be difficult, but it is crucial to their optimal treatment. Consequently, numerous scoring systems have been developed around the world to categorize patient states based on physiological assessments. Although validated and widely adopted by medical communities, these scores still present numerous limitations and obstacles. Even with the addition of additional tests and extensions, these scoring systems have not been able to overcome certain limitations, and it appears unlikely that they will be able to do so in the future. On the other hand, physiological tests are not the only way to extract ideas about comatose patients. EEG signal analysis has helped extensively to understand the human brain and human consciousness and has been used by researchers in the classification of different levels of disease. The use of EEG in the ICU has become an urgent matter in several cases and has been recommended by medical organizations. In this field, the EEG is used to investigate epilepsy, dementia, brain injuries, and many other neurological disorders. It has recently also been used to detect pain activity in some regions of the brain, for the detection of stress levels, and to evaluate sleep quality. In our recent findings, our aim was to use multifractal analysis, a very successful method of handling multifractal signals and feature extraction, to establish a state of awareness scale for comatose patients based on their electrical brain activity. The results show that this score could be instantaneous and could overcome many limitations with which the physiological scales stock. On the contrary, multifractal analysis stands out as a highly effective tool for characterizing non-stationary and self-similar signals. It demonstrates strong performance in extracting the properties of fractal and multifractal data, including signals and images. As such, we leverage this method, along with other features derived from EEG signal recordings from comatose patients, to develop a scale. This scale aims to accurately depict the vigilance state of patients in intensive care units and to address many of the limitations inherent in physiological scales such as the Glasgow Coma Scale (GCS) and the FOUR score. The results of applying version V0 of this approach to 30 patients with known GCS showed that the EEG-based score similarly describes the states of vigilance but distinguishes between the states of 8 sedated patients where the GCS could not be applied. Therefore, our approach could show promising results with patients with disabilities, injected with painkillers, and other categories where physiological scores could not be applied.

Keywords: coma, vigilance state, EEG, multifractal analysis, feature extraction

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Authors: Nikk Leavitt, Peter Kellett, Cheryl Currie, Richard Larouche

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Background: Masculinity has been associated with poor mental health outcomes in adult men and is colloquially referred to as toxic. Masculinity is traditionally measured using the Male Role Norms Inventory, which examines behaviors that may be common in men but that are themselves associated with poor mental health regardless of gender (e.g., aggressiveness). The purpose of this study was to examine if masculinity is associated with generalized anxiety among men using this inventory vs. a man’s personal definition of it. Method: An online survey collected data from 1,200 men aged 18-65 across Canada in July 2022. Masculinity was measured using: 1) the Male Role Norms Inventory Short Form and 2) by asking men to self-define what being masculine means. Men were then asked to rate the extent they perceived themselves to be masculine on a scale of 1 to 10 based on their definition of the construct. Generalized anxiety disorder was measured using the GAD-7. Multiple linear regression was used to examine associations between each masculinity score and anxiety score, adjusting for confounders. Results: The masculinity score measured using the inventory was positively associated with increased anxiety scores among men (β = 0.02, p < 0.01). Masculinity subscales most strongly correlated with higher anxiety were restrictive emotionality (β = 0.29, p < 0.01) and dominance (β = 0.30, p < 0.01). When traditional masculinity was replaced by a man’s self-rated masculinity score in the model, the reverse association was found, with increasing masculinity resulting in a significantly reduced anxiety score (β = -0.13, p = 0.04). Discussion: These findings highlight the need to revisit the ways in which masculinity is defined and operationalized in research to better understand its impacts on men’s mental health. The findings also highlight the importance of allowing participants to self-define gender-based constructs, given they are fluid and socially constructed.

Keywords: masculinity, generalized anxiety disorder, race, intersectionality

Procedia PDF Downloads 48

Authors: Les Moncrieff

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In a world awash with potent opioids flaming an international crisis, the need to explore safe alternatives has never been more urgent. Bio-electrode Therapy is a novel adjunctive treatment method for relieving acute opioid withdrawal symptoms and many types of complex acute and chronic pain (often the underlying cause of opioid dependence). By combining the science of developmental bioelectricity with Traditional Chinese Medicine’s theory of meridians, rapid relief from pain is routinely being achieved in the clinical setting. Human body functions are dependent on electrical factors, and acupuncture points on the body are known to have higher electrical conductivity than surrounding skin tissue. When tiny gold- and silver-plated electrodes are secured to the skin at specific acupuncture points using established Chinese Medicine principles and protocols, an enhanced microcurrent and electrical field are created between the electrodes, influencing the entire meridian and connecting meridians. No external power source or electrical devices are required. Endogenous DC electric fields are an essential fundamental component for development, regeneration, and wound healing. Disruptions in the normal ion-charge in the meridians and circulation of blood will manifest as pain and development of disease. With the application of these simple electrodes (gold acting as cathode and silver as anode) according to protocols, the resulting microcurrent is directed along the selected meridians to target injured or diseased organs and tissues. When injured or diseased cells have been stimulated by the microcurrent and electrical fields, the permeability of the cell membrane is affected, resulting in an immediate relief of pain, a rapid balancing of positive and negative ions (sodium, potassium, etc.) in the cells, the restoration of intracellular fluid levels, replenishment of electrolyte levels, pH balance, removal of toxins, and a re-establishment of homeostasis.

Keywords: bioelectricity, electrodes, electrical fields, acupuncture meridians, complex pain, opioid withdrawal management

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Authors: Neil Singla, Derek Muse, Karen DiDonato, Pamela Palmer

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Introduction: Pain is the most common reason people visit emergency rooms. Studies indicate however, that Emergency Department (ED) physicians often do not provide adequate analgesia to their patients as a result of gender and age bias, opiophobia and insufficient knowledge of and formal training in acute pain management. Novel classes of analgesics have recently been introduced, but many patients suffer from acute pain in settings where the availability of intravenous (IV) access may be limited, so there remains a clinical need for rapid-acting, potent analgesics that do not require an invasive route of delivery. A sublingual sufentanil tablet (SST), dispensed using a single-dose applicator, is in development for treatment of moderate-to-severe acute pain in a medically-supervised setting. Objective: The primary objective of this study was to demonstrate the repeat-dose efficacy, safety and tolerability of sufentanil 20 mcg and 30 mcg sublingual tablets compared to placebo for the management of acute pain as determined by the time-weighted sum of pain intensity differences (SPID) to baseline over the 12-hour study period (SPID12). Key secondary efficacy variables included SPID over the first hour (SPID1), Total pain relief over the 12-hour study period (TOTPAR12), time to perceived pain relief (PR) and time to meaningful PR. Safety variables consisted of adverse events (AE), vital signs, oxygen saturation and early termination. Methods: In this Phase 2, double-blind, dose-finding study, an equal number of male and female patients were randomly assigned in a 2:2:1 ratio to SST 20 mcg, SS 30 mcg or placebo, respectively, following bunionectomy. Study drug was dosed as needed, but not more frequently than hourly. Rescue medication was available as needed. The primary endpoint was the Summed Pain Intensity Difference to baseline over 12h (SPIDI2). Safety was assessed by continuous oxygen saturation monitoring and adverse event reporting. Results: 101 patients (51 Male/50 Female) were randomized, 100 received study treatment (intent-to-treat [ITT] population), and 91 completed the study. Reasons for early discontinuation were lack of efficacy (6), adverse events (2) and drug-dosing error (1). Mean age was 42.5 years. For the ITT population, SST 30 mcg was superior to placebo (p=0.003) for the SPID12. SPID12 scores in the active groups were superior for both male (ANOVA overall p-value =0.038) and female (ANOVA overall p-value=0.005) patients. Statistically significant differences in favour of sublingual sufentanil were also observed between the SST 30mcg and placebo group for SPID1(p<0.001), TOTPAR12(p=0.002), time to perceived PR (p=0.023) and time to meaningful PR (p=0.010). Nausea, vomiting and somnolence were more frequent in the sufentanil groups but there were no significant differences between treatment arms for the proportion of patients who prematurely terminated due to AE or inadequate analgesia. Conclusions: Sufentanil tablets dispensed sublingually using a single-dose applicator is in development for treatment of patients with moderate-to-severe acute pain in a medically-supervised setting where immediate IV access is limited. When administered sublingually, sufentanil’s pharmacokinetic profile and non-invasive delivery makes it a useful alternative to IM or IV dosing.

Keywords: acute pain, pain management, sublingual, sufentanil

Procedia PDF Downloads 337

Authors: Domenica Tambasco, Riina Bray, Sophia Jaworski, Gillian Grant, Celeste Corkery

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Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, and reduced function. Management of symptoms include medications, physical treatments and mindfulness therapies. Myofascial Release is a modality that has been successfully applied in var-ious musculoskeletal conditions. However, to the author’s best knowledge, it is not yet recog-nized as a self-management therapy option in Fibromyalgia. In this study, we investigated whether Self-applied Myofascial Release (SMR) is associated with overall improved function and symptoms in Fibromyalgia. Methods: Eligible adult patients with a confirmed diagnosis of Fibromyalgia at Women’s College Hospital were recruited to SMR. Sessions ran for 1 hour once a week for 7 weeks, led by the same two Physiotherapists knowledgeable in this physical treat-ment modality. The main outcome measure was an overall impact score for function and symp-toms based on the validated assessment tool for Fibromyalgia, the Revised Fibromyalgia Impact Questionnaire (FIQR), measured pre and post-intervention. Both descriptive and analytical methods were applied and reported. Results: We analyzed results using a paired t-test to deter-mine if there was a statistically significant difference in mean FIQR scores between initial (pre-intervention) and final (post-intervention) scores. A clinically significant difference in FIQR was defined as a reduction in score by 10 or more points. Conclusions: Our pilot study showed that SMR appeared to be a safe and effective intervention for our Fibromyalgia participants and the overall impact on function and symptoms occurred in only 7 weeks. Further studies with larger sample sizes comparing SMR to other physical treatment modalities (such as stretching) in an RCT are recommended.

Keywords: fibromyalgia, myofascial release, physical therapy, FIQR

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Authors: Amina Bayazid, Habiba Fetati, Houari Toumi

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Introduction: The clinical value of vitamin K antagonists (VKA) has been widely demonstrated in numerous indications. Unfortunately, VKA are not devoid of drawbacks and risk of serious bleeding. The iatrogenic induced by these drugs is a major public health problem. Patients & Methods: We conducted a retrospective study period extending from February 2012 to August 2013 in the pharmacovigilance service of EHUO (clinical pharmacology unit). The prescription of painkillers was analyzed in patients on VKA followed at our level. The influence of these analgesics on the evolution of the INR is an important component in our work. Results: We counted a total of 195 patients, of whom 32 (or 16.41% of the total population) had received analgesic treatment. The frequencies of different categories of analgesics administered were: • Analgesics opioids: 0% • Analgesics weak opioids: Tramadol: 21.87% • The non-opioid analgesics: -AINS: 71.87% (indomethacin: 68.75% ibuprofen: 3.12%) - Paracetamol: 6.25% -Salicyles (Acetylsalicylic acid): 0%. Conclusion: The management of pain in patients under vitamin K antagonists has special features, given their many drug interactions with analgesics and their influence on the evolution of the INR which can have dramatic consequences. As such, special attention must be paid to the use of analgesics in this type of patient.

Keywords: vitamin K antagonists, pain killers, interactions, INR

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