Informed Consent Form Research Articles

Safety and efficacy of ketorolac in improving the prognosis of acute type A aortic dissection patients: a protocol of a randomized, double-blinded, and placebo-controlled study

BackgroundAcute type A aortic dissection (aTAAD) is a critical and life-threatening condition. Previous research has demonstrated that the use of ketorolac not only reduces the progression, incidence, and severity of aortic aneurysms in animal models, but also decreases postoperative mortality and complications in patients undergoing open abdominal aortic aneurysm replacement. However, there is a lack of studies investigating the efficacy of ketorolac in treating aTAAD in humans. Therefore, we conducted a study to evaluate the safety and efficacy of ketorolac in patients with aTAAD. Our hypothesis was that ketorolac treatment for aTAAD patients would meet safety indicators and effectively improve patient prognosis.Methods/designThis study is a single-center, randomized, double-blinded, and placebo-controlled study. A total of 120 patients with aTAAD will be recruited and will be randomized into the ketorolac group and placebo group with a ratio of 1:1. Ketorolac tromethamine 60 mg per 2 ml will be intramuscularly injected within 2 h before surgery, followed by intramuscular injections of 30 mg per 1 ml BID. on the first and second postoperative days in the Ketorolac group, while 0.9% saline will be administered at the same dose, dosage form, and time in the placebo group. This study aims to evaluate the safety and efficacy of ketorolac in improving the prognosis of aTAAD. The primary endpoint is the composite endpoint event concerning drug-related adverse events. Secondary endpoints include drug-related adverse events, laboratory examination of blood, diagnostic imaging tests, clinical biomarkers, etc.DiscussionThis study has been approved by the Medical Ethics Committee of Affiliated Nanjing Drum Tower Hospital, Nanjing University Medical College (approval number: 2023–197-02). This study is designed to evaluate the safety and efficacy of ketorolac in patients with aTAAD. All participating patients will sign an informed consent form, and the trial results will be published in international peer-reviewed journals.Trial registrationThe Chinese Clinical Trial Registry (http://www.chictr.org.cn) ChiCTR2300074394. Registered on 4 October 2023.

Prevalence and Effect of Computer Vision Syndrome during COVID-19: among Bangladeshi People

Background: Global pandemic has devastated almost every aspect of life. "Spatial distancing" involves creating and maintaining safe social distance, shifting the world away from public locations and toward isolation. Remote working has become a demand in these historically unique times, and technology is a need for human life as a link to the outside world. People use technology to interact, communicate, and complete activities. Online meetings, audio and video conferencing, and leisure activities like online gaming, blogging, and social networking have virtualized human interaction, leading to a rapid digitalization of human life. The increased usage of video display terminals (VDTs) predisposes to a range of problems. Digital eye strain (DES) or computer vision syndrome (CVS) refers to a group of health disorders that include not only visual issues but also musculoskeletal issues. Objective: The aim of this study is to determine the prevalence of CVS and to examine the use of digital screens, common symptoms, and related variables. The findings could in the future provide vital, detailed health information to all online users. Methods and Materials: A descriptive cross-sectional study was conducted from 1st July to 31st December, 2021. A total of 429 people participated in the study and majority of the participants were students and teachers involved in digital class rooms for academic purposes. A survey questionnaire was distributed on social media channels. Regular users of digital screens were provided with Google forms through social media. It includes both a questionnaire and an informed consent form. Results: Out of 429 participants in, 59.9% were females and 36.13% males. The maximum age group were from between 18-27, 58.9%, while the least were from 58 and above, 2%. The major digital screen platforms used by them were smartphone/tablet, 97.9%, television, 70.8% and computer laptop, 66.8%. The utilization of digital screens was categorized under ..........

Standardized Informed Consent Form for Clinicians Administering Platelet-Rich Plasma

Standardized Informed Consent Form for Clinicians Administering Platelet-Rich Plasma

Clinical evaluation on the use of a new accessory device for Fox plane.

Evaluate the assimilation capacity and ease of handling of the Fox plane accessory by dentistry students, through a questionnaire about the experience in using this device compared to the conventional one. Its intention is to minimize possible interpretation errors and challenges that the traditional method determines. After approval by the Research Ethics Committee, registration at Sistema Nacional de Informações sobre Ética em Pesquisa/National Information System on Research Ethics (SISNEP) and signing of the free and informed consent form, 51 undergraduate students treating patients in need of complete dentures at Instituto de Ciência e Tecnologia/Institute of Science and Technology (ICT) Unesp in São José dos Campos completed a questionnaire to evaluate the technical ease of use and provider acceptance. The obtained data were submitted to statistical analysis, evaluating technical ease and acceptance by operators. The results were analyzed using descriptive and inferential statistics using the Jamovi 2.2.5 software. From the responses, the frequency was obtained for each question in the questionnaire, then the weighted mean was calculated, average rating and percentage. With the results of these analyses it was possible to measure the level of satisfaction of the participants in relation to the use of the device. It was concluded that most students have difficulty using the conventional Fox plane and that the accessory facilitated the process of determining the superior orientation plane, and its ease of use.

Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer (DESTINY-Lung01): primary results of the HER2-overexpressing cohorts from a single-arm, phase 2 trial

DESTINY-Lung01 is a multicentre, open-label, phase 2 study evaluating the antitumour activity and safety of trastuzumab deruxtecan, a HER2-directed antibody-drug conjugate, in patients with HER2-overexpressing or HER2 (ERBB2)-mutant unresectable or metastatic non-small-cell lung cancer (NSCLC). The results of the HER2-mutant cohort (cohort 2) have been reported elsewhere. Herein, we report the primary analysis of cohorts 1 and 1A, which aimed to evaluate the activity and safety of trastuzumab deruxtecan 5·4 mg/kg and 6·4 mg/kg in patients with HER2-overexpressing NSCLC. Patients aged 18 years or older with unresectable or metastatic (or both unresectable and metastatic) non-squamous NSCLC who had relapsed following or were refractory to standard treatment or for whom no standard treatment was available, with an HER2 immunohistochemistry score of 3+ or 2+ (without known HER2 mutations) and an Eastern Cooperative Oncology Group performance status score of 0 or 1, were enrolled at 20 specialist hospitals in France, Japan, the Netherlands, Spain, and the USA. Patients were assigned to cohorts sequentially, first to cohort 1, to receive trastuzumab deruxtecan 6·4 mg/kg (cohort 1), then to cohort 1A, to receive trastuzumab deruxtecan 5·4 mg/kg, both administered intravenously once every 3 weeks. The primary endpoint was confirmed objective response rate by independent central review and was assessed in the full analysis set, which included all patients who signed an informed consent form and were enrolled in the study. Safety was assessed in all enrolled patients who received at least one dose of trastuzumab deruxtecan. This trial is registered with ClinicalTrials.gov, NCT03505710, and is ongoing (closed to recruitment). Between Aug 27, 2018, and Jan 28, 2020, 49 patients were enrolled in cohort 1 (median age 63·0 years [IQR 58·0-68·0], 30 [61%] male, 19 [39%] female, and 31 [63%] White), and from June 16 to Dec 9, 2020, 41 patients were enrolled in cohort 1A (median age 62·0 years [IQR 56·0-66·0], 22 [54%] male, 19 [46%] female, and 31 [76%] White). As of data cutoff (Dec 3, 2021), the median treatment duration was 4·1 months (IQR 1·4-7·1) in cohort 1 and 5·5 months (1·4-8·7) in cohort 1A, and median follow-up was 12·0 months (5·4-22·4) in cohort 1 and 10·6 months (4·5-13·5) in cohort 1A. Confirmed objective response rate by independent central review was 26·5% (95% CI 15·0-41·1; 13 of 49, all partial responses) in cohort 1 and 34·1% (20·1-50·6; 14 of 41; two complete responses and 12 partial responses) in cohort 1A. The most common treatment-emergent adverse events of grade 3 or worse were neutropenia (12 [24%] of 49 in cohort 1, none in cohort 1A), pneumonia (six [12%] and two [5%], respectively), fatigue (six [12%] and three [7%], respectively), and disease progression (six [12%] and four [10%], respectively). Drug-related treatment-emergent adverse events of grade 3 or worse occurred in 26 (53%) of 41 patients in cohort 1 and nine (22%) of 49 patients in cohort 1A. Drug-related serious adverse events were reported in ten (20%) patients and three (7%) patients, respectively. Deaths due to treatment-emergent adverse events occurred in ten (20%) patients in cohort 1 (disease progression in six (12%) patients and bronchospasm, hydrocephalus, respiratory failure, and pneumonitis in one [2%] patient each), and in seven (17%) patients in cohort 1A (due to disease progression in four (10%) patients and dyspnoea, malignant neoplasm, and sepsis in one (2%) patient each). One death due to a treatment-emergent adverse event was determined to be due to study treatment by the investigator, which was in cohort 1 (pneumonitis). Independent adjudication of interstitial lung disease or pneumonitis found that drug-related interstitial lung disease or pneumonitis occurred in ten (20%) patients in cohort 1 (two [4%] grade 1, five [10%] grade 2, and three [6%] grade 5) and two (5%) patients in cohort 1A (one [2%] grade 2 and one [2%] grade 5). An additional patient in cohort 1A had grade 4 pneumonitis after the data cutoff, which was subsequently adjudicated as drug-related grade 5 interstitial lung disease or pneumonitis. Given the low antitumour activity of existing treatment options in this patient population, trastuzumab deruxtecan might have the potential to fill a large unmet need in HER2-overexpressing NSCLC. Our findings support further investigation of trastuzumab deruxtecan in patients with HER2-overexpressing NSCLC. Daiichi Sankyo and AstraZeneca.

The effect of fingerprint enhancement methods applied on adhesive surfaces on DNA recovery: a preliminary study

The presence of body fluids such as blood, saliva, semen or urine during fingerprint research on the evidence taken from the crime scene makes it necessary to protect biological materials to examine the evidence in multiple ways. Therefore, it is crucial that fingerprint development (FD) techniques do not disrupt the structure of biological materials during FD procedures. In this sense, it is essential to determine whether biological material or fingerprints should be the priority during the collection of evidentiary materials, to determine the systematic order and to determine whether the FD methods to be applied cause damage to the genetic material used in the identification of individuals and to evaluate them in terms of their evidentiary quality. This study investigated the effects of the application of trace detection methods on DNA profiling processes in evidence where fingerprints and biological samples are found at the same time. In this study, blood, saliva, semen and urine samples were taken from a male individual who signed an informed consent form at the laboratory stage. The samples were applied 50 µL on the adhesive tape surface. After application, the samples were treated with crystal violet (CV) and sticky side (SS) fingerprint development chemicals suitable for the surface type. The prepared samples were dried under room conditions. After 1 day and 45 days under normal room conditions, silica-based DNA extraction was performed. After extraction, DNA quantification was performed using the fluorimetry method. In the study, biological samples with known DNA content were used to focus on DNA quantification. Among the fresh samples prepared in the study, DNA recovery was higher in the SS-treated urine, blood and saliva samples and in the CV-treated semen sample group compared to the other groups. This shows that chemical treatment of some biological samples on adhesive tape increases the efficiency of DNA recovery. When the 45-day waiting samples were compared with the control group samples, DNA recovery decreased in CV-treated urine and blood samples, while DNA recovery increased in SS-treated urine and blood samples. In semen samples, both CV and SS treatment negatively affected DNA recovery. In saliva samples, DNA recovery increased ~2-fold in the CV-treated sample group, while SS treatment caused a ~75% decrease in DNA recovery. The results show that the non-porous adhesive tape does not adversely affect the amount of DNA in terms of STR profiling of latent FD chemicals used on the surfaces and that adhesive tape treated with fingerprint enhancement chemicals can actually be used for advanced forensic genetic analyses for DNA extraction on surfaces.

Utilization and Satisfaction of Community-based Health Care Services among Older Adults

The COVID-19 pandemic has a significant impact on the capacity of health systems to continue to provide critical services. As healthcare systems around the world face a growing demand for care for patients with COVID-19, it is vital to maintain preventive and curative services, especially for the most vulnerable populations, the elderly and the elderly living with chronic diseases. The purpose of this study was to determine the level of health service utilization and satisfaction of older adults amidst COVID-19 pandemic. The study used a descriptive- correlational research design that was conducted in a selected barangay in the city of Caloocan. The purposive and snowball sampling method was used to select respondents and must meet the following criteria: elderly between the ages of 60 and 74, and using health care services. The data collection was carried out through a series of questionnaires with an informed consent form through online platforms. Based from the data gathered, the strength of the relationship is indicated by the correlation coefficient with a score of. 795, which is greater than 0.70 shows a high correlation between the two variables. This means that when the level of utilization of community-based services of the respondent is high, their level of satisfaction with health care services increases as well. Overall, it is important to prioritize the level of utilization and satisfaction in community-based healthcare among older adults as it is used as an indicator for measuring the quality of healthcare. The level of utilization among older adults is inclined to their level of satisfaction, in which respondents are highly satisfied with their usage of services in terms of accessibility, availability and affordability of the community-based services. Moreover, demographic profile of respondents has no significant difference, which indicates that respondent’s level of satisfaction in community-based services is affected by their level of utilization of services in their barangay health center. Health services, if used by the elderly, can lead to satisfaction. Therefore, the promotion of the various health services is strongly encouraged to reach not only a few, but the whole population.

(O-40) THERAPEUTIC GROUPS FOR MEN WITH PENILE OR TESTICULAR CANCER

Abstract   The incidence of cancer in the world population in 2002 was estimated at 11 million new cases, in 2020 this estimate is approximately 20 million. Cancer is a global public health problem. Testicular cancer (TC) mainly affects men aged 15 to 40 years, and the incidence is about 5/100,000. Typically, tumors are aggressive and cause a great psychological impact on patients. Penile cancer (PC) represents 2% of all types of tumors that affect men in Brazil. The majority of the affected population are elderly men. Normally the tumor is identified at an advanced stage, when the only available treatment is total or partial penectomy, causing great emotional impact. This work aims to evaluate the impact of psychotherapy, in an open group, on the Quality of Life Related to Health and Sexuality in patients with CT and CP who have been diagnosed, are undergoing treatment or are being monitored after treatment. Data are collected through an initial interview (Identification, Anamnesis, Health Anamnesis, Degree of Satisfaction with Life and Sexuality, Affective-Emotional Assessment and Treatment Data), SF-36 questionnaire and IIEF-5 short form, in patients who were diagnosed, underwent treatment or are being monitored at the outpatient clinic, and reapplied at the end of 12 sessions. At each session, 5 questions are answered regarding the perception of the previous session. The group is available once a week for 12 weeks. Sessions last 90 minutes, led by the same psychologist. The research is being developed considering the ethical principles of secrecy, privacy and confidentiality. At the beginning of the process, the Free and Informed Consent Form is delivered as well as details regarding the research. It is also explained that participation is voluntary and that the participant may leave the research at any time, without this affecting their treatment and follow-up. Financing No conflict.

(O-32) PRIMARY DEPTH DYSPAREUNIA IS CAUSED BY THE INCOMPATIBILITY OF THE SIZE OF THE PENIS WITH THE VAGINA

Abstract Introduction/Objective Dyspareunia, to this day, is not yet fully understood. It is known that the size of the distended vagina is variable, as well as the size of the penis. A vagina distended by a larger penis, suffers trauma and pain. The work aims to measure the flexibility of the human vagina, to guide professionals, who treat women with this complaint. Methods Women who signed the informed consent form and underwent vaginal surgeries under anesthesia had their vagina measured in the specular examination according to the POP-Q (total length of the vagina, measurement from the hymen to the deepest portion of the vagina) and also the same measurement with maximum distension of the vagina verified by the resistance to the introduction of a centimetric device. The difference in the measurements obtained determined the flexibility of the vagina in centimeters. Results A total of 120 vaginas were measured. The smallest vagina, measured without distention, was 5 centimeters and with distension of 10 centimeters. The largest, without distension, was 13.5 centimeters and with distension of 16 centimeters. Women with genital prolapse showed greater flexibility, ranging from 0.5 cm to 8 cm. Conclusions 1-The largest measured distention of a vagina was 16 centimeters, which implies that penises larger than 16 centimeters, if penetrated completely, will cause some degree of vaginal trauma. 2-The smallest distended vagina measured 10 centimeters, so any penis that penetrates 10 centimeters into the female vagina will not cause trauma. 3-Women with complaints of pelvic pain associated with depth dyspareunia should be advised about trauma to the vaginal fundus or presence of gynecological pathology, as well as Relative Short Vagina Syndrome. 4-Professionals who serve women and couples need to understand this new concept of depth dyspareunia. However, further well-controlled studies should be conducted to consolidate this new knowledge. Financing No conflict.

(PM-07) EVALUATION OF SEXUAL HEALTH EDUCATION IN THE FACULTY OF MEDICAL SCIENCES OF THE UNIVERSITY OF CAMPINAS: SEXUAL COMMUNICATION IN PATIENT-DOCTOR RELATIONSHIP APPROACH

Abstract Introduction/objectives Sexual dysfunction, present in 43% of women and 31% of men, is the result of several pathological conditions and must be properly investigated and treated. About 50 to 72% of physicians experience difficulty and do not regularly investigate their patients' sexual health. The study investigates the teaching and approach to sexual health in the medical graduation at the Faculty of Medical Sciences of the State University of Campinas, in order to detect gaps that justify the difficulty in discussing this aspect. Materials and Methods Descriptive and transversal study is in progress, including medical students that are above 18 years old and are in the fifth or sixth year of their graduation. Anonymously and after reading the Informed Consent Form, the online questionnaire, composed of questions related to the theoretical and practical approaches in sexuality and the knowledge that they have been receiving in medical school, can be answered. Results The online questionnaire was answered by 64 students in the fifth and sixth year of graduation (1.6% and 98.4%, respectively). 43.5% denied being effectively prepared and confident, 35.5% are uncertain and only 21% feel prepared to discuss the subject with their patients. The main theme approached involves mostly the female sexuality, being the reproductive focus (85.2%), abortion (85.2%) and sexual violence (83.6%) the most discussed subjects. Only 4 students indicate that they understand male dysfunctions. A minority of participants (21.9%) felt safe to address sexual issues with their patients. Conclusions Most of the students do not feel comfortable or confident and lack specific knowledge and skills to deal with questions related to sexuality. More time should be dedicated to education, theoretical and practical classes, concerning human sexuality and its cultural, societal, and health aspects in the graduation during medical school. Financing No conflict.

Protocol for the "magnitude of cigarette substitution after initiation of e-cigarettes and its impact on biomarkers of exposure and potential harm in dual users" (MAGNIFICAT) study.

Many smokers who use e-cigarettes (ECs) to quit continue smoking alongside vaping. The impact on health among individuals who simultaneously smoke conventional cigarettes (CCs) and use ECs remains unclear. The varying patterns of dual use present differing levels of overall toxin exposure and relative risks concerning smoking-related diseases. Understanding these complexities is vital to assessing the implications for human health. Herein we describe a protocol designed to analyze the impact of different level of substituting CCs with ECs on exposure to toxicants. We'll use biomarkers to measure this exposure and assess harm reduction in dual users through clinical endpoints, harm-related biomarkers, and behavioral correlations. We expect to observe progressive changes with varying patterns of dual use. For this purpose, we planned to recruit a group of 250 smokers who will be asked to reduce their CC consumption by adopting ECs (intervention group). A separate group of 50 smokers will continue to smoke CC (reference group). Study groups will be followed up for 6 months during which biospecimens will be collected for biomarker analyses, and clinical endpoints will be assessed. The trial is structured to characterize subjects' usage patterns over time using robust biomarkers of exposure and a standardized mobile phone application to facilitate the precise categorization of dual users along the risk continuum based on their usage behaviors. Subject recruitment will start in February 2024 and enrolment is expected to be completed by August 2024. Results will be reported early in 2025. Study findings may provide valuable insights into health benefits or risks associated with varying patterns of dual use. The study protocol and informed consent forms will be approved by the local Ethical Review Boards. Study results will be disseminated through articles published in reputable, peer-reviewed, open access, scientific journals, presentations at conferences, and the University website.

Kinesophobia and its related factors in patients after percutaneous coronary intervention: A cross-sectional study.

To explore the postoperative kinesophobia of patients after percutaneous coronary intervention (PCI) and its related factors. Percutaneous coronary intervention is an effective method to treat coronary heart disease (CHD), and cardiac rehabilitation is an important auxiliary method after PCI. However, the compliance of patients with cardiac rehabilitation after PCI is not good, among which kinesophobia is an important influencing factor. A descriptive cross-sectional design was implemented, and the high-quality reporting of the study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology Statement. In total, 351 inpatients who underwent PCI in three tertiary grade-A hospitals in China were selected by convenient sampling method. We use one-way ANOVA and multiple linear regression analysis to determine the relevant related factors. The kinesophobia of patients after PCI was negatively correlated with chronic illness resource utilization and sense of personal mastery, and positively correlated with illness perception. Education level, clinical classification of CHD, exercise habits, chronic illness resource utilization, illness perception and sense of personal mastery entered the regression equation, which could explain 78.1% of the total variation. The level of kinesiophobia of patients after PCI is high. Education level, clinical classification of CHD, exercise habits, chronic illness resource utilization, illness perception and sense of personal mastery are the related factors of kinesiophobia of patients after PCI. By reducing the level of exercise fear of patients after PCI, patients are more likely to accept and adhere to the cardiac rehabilitation plan, thus improving their prognosis and improving their quality of life. The patient underwent PCI in the research hospital. Researchers screen them according to the inclusion criteria and invite them to participate in this study. If they meet the requirements, participants will answer the research questionnaire face to face after signing the informed consent form.

Nursing students' attitude toward euthanasia following its legalization in Spain.

Euthanasia is a controversial practice in many countries. Since Spain's Euthanasia Law came into effect on March 24, 2021, healthcare providers have faced a new challenge since they must inform patients, provide care, accompany them, and implement the law. It also represents a new stumbling block at universities, which must adapt to regulatory changes and educate future professionals accordingly. Little is known about the attitude of nursing students in Spain toward euthanasia since this law was implemented. This study aims to answer the following research questions: What is the attitude of nursing students toward euthanasia? What factors influence this attitude? A cross-sectional study was conducted using an online questionnaire. The study population comprised all nursing students at a public university in Barcelona (n = 444), Spain, during the 2022-2023 academic year. The validated Spanish version of the Euthanasia Attitude Scale was employed. A bivariate analysis was performed. The university Ethics Committee (CEEAH 6247) approved this study. All participating students signed an informed consent form. Participation was voluntary, and data anonymity and confidentiality were guaranteed. Two hundred and forty-four nursing students responded to the questionnaire. The mean total score was 79.64. Participants with religious beliefs presented lower scores, indicating a more negative attitude toward euthanasia. Participants in their second, third, or fourth year of the nursing degree scored higher, demonstrating a more positive attitude. The attitude of nursing students toward euthanasia was remarkably positive. Working on ethical content during the degree course and clinical practice are factors that help to develop a more positive attitude. In addition, nursing education should encourage professional aspects to prevail over religious beliefs in euthanasia situations.

Assessment of Knowledge and Attitude Regarding Teledentistry Among Dental Professionals: A Cross-Sectional Study.

Modern technologies have led to the development of new tools, practices, and digital techniques. However, their use in public health to provide adequate oral health facilities to the community is limited. One of the facilities that can help provide better oral health with minimal cost is teledentistry. The application of this approach will reduce inequalities in accessing oral healthcare. Knowledge of the use of teledentistry is of the utmost importance to its practice. Hence, the objective of this cross-sectional study is to assess the knowledge of and attitude regarding teledentistry among dental professionals in the Sangli district of Maharashtra. A 24-unit structured online validated questionnaire with six questions regarding participants' sociodemographic information and 18 questions related to their knowledge and attitude toward teledentistry and informed consent forms were circulated via email among 100 dentists, and the responses obtained were analyzed. Out of 100 responses, 61 showed basic knowledge and a typical attitude toward teledentistry. Urban practitioners were more familiar with teledentistry than rural ones. This survey concludes that the branch of teledentistry still needs to be studied and publicized at a greater level to accelerate its widespread implementation in dentistry and especially to increase the outreach and time efficiency of dentistry.

Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension

Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension

Universal screening for early detection of chronic autoimmune, metabolic and cardiovascular diseases in the general population using capillary blood (UNISCREEN): low-risk interventional, single-centre, pilot study protocol

IntroductionChronic autoimmune (type 1 diabetes and coeliac disease) and metabolic/cardiovascular (type 2 diabetes, dyslipidaemia, hypertension) diseases are highly prevalent across all age ranges representing a major public health burden. Universal...

Sociological determinants of adherence to continuous positive airway pressure in the management of sleep apnoea syndrome: protocol for a transdisciplinary, prospective observational study

IntroductionObstructive sleep apnoea syndrome (OSAS) is a chronic multiorgan pathology that has a negative impact on quality of life. Continuous positive airway pressure (CPAP) is the first-line treatment for OSAS....

(053) Efficacy of Mindfulness Based Cognitive Therapy in Management of Provoked Vulvodynia: A Feasibility Pilot Study

Abstract Introduction Provoked Vulvodynia (PVD) is an evolving and chronic pain disorder frequently reported by women of reproductive age. Provoked Vulvodynia is a debilitating disorder and causes significant impairment in daily functioning. Objective The present study was designed with an aim to compare the efficacy of mindfulness based cognitive therapy (MBCT) with pharmacotherapy in the management of PVD in Pakistani women. Methods The present study was approved by the Ethics Review Board (ERB) of Institute of Psychological Research, Pakistan vide No. IPR/ERB/PVD/2023/006. A randomized trial design was used in this study. The women suffering from vulvodynia were included in the study. On the other hand, the women suffering from any gynecological disease, psychiatric disease, or any other medical disease or using any substance were excluded from the study. A total of 43 women suffering from PVD were referred for the treatment. 14 women were excluded as they did not meet the inclusion criteria. All women signed the compulsory informed consent form before enrolling for the study. 29 women were randomized in two treatment groups namely Group A which received 1 hour weekly session of mindfulness based cognitive therapy and Group B which received pharmacotherapy for a period of 3 months. Pharmacotherapy included Amitriptyline 25–50mg daily, Gabapentin 100–300 mg daily, and Lidocaine ointment 5% applied locally to the vestibule. There were 14 women in Group A and 15 women in Group B. A total of 6 women were dropped from the Group A and Group B because they did not want to complete the treatment protocol. 11 women in Group A and 12 women in Group B completed the treatment protocol and their data were added to the statistical analyses. The Vulvar Pain Functional Questionnaire (V-Q) was used as the main outcome measure for pretest and posttest assessments. The data was analyzed by using the Statistical Package for the Social Sciences (SPSS) version 27. Results The mean age of the women was (M=34, SD=3.13) for Group A and (M=34.41, SD=3.26) for Group B. The data was analyzed by using the Wilcoxon Signed Rank Test as the data was non parametric. There was statistical significant Z= -2.94, p<.05 for Group A and Z= -3.07, p<.05 for Group B. The results established that both mindfulness based cognitive therapy and pharmacotherapy were effective in relieving symptoms of PVD. Conclusions The present study concluded that mindfulness based cognitive therapy was as effective in relieving symptoms of PVD as pharmacotherapy. The lack of control group was a major limitation of the study. However, the future studies may be conducted with other treatment arms such as pelvic floor therapy and by adding more women in treatment and control groups. The present study may be considered as a feasibility/pilot study for the efficacy of MBCT for treatment of PVD in Pakistani women. Disclosure No.

(129) Penile Girth Enhancement Using UroFill™: The Brazilian Experience

Abstract Introduction Demands for penile girth enhancement are increasing. UroFill™ is the innovative approach that offers non-surgical and reproducible penile girth enhancement. Objective To demonstrate the penile girth before and after the application of hyaluronic acid with the UroFill™ technique Methods A retrospective, single-center study included men who sought private care to realize penile girth enhancement using UroFill™ technique from April to June 2023. All patients signed an informed consent form. Excluded men with dysmorphophobia, active inflammatory-infectious genital lesion, and prior application of another filler. Penile girth was measured with a tape measure at baseline and after 21 days. Results 21 patients were included in this analysis. Mean injected volume was 5.81ml. Compared a mean with a basal girth of 9.11±1.1cm and after 1 application 10.85±0.9cm and the Test t result was significant p < 0.001. There were no inflammatory signs or serious adverse reactions in all cases, and no patient requested a reversal of the procedure. Conclusions This study demonstrates the increase in penile girth after just one application of hyaluronic acid using the Urofill technique. In addition, we did not find any cases of complications in the evaluated patients, which suggests a safe procedure. Disclosure No.

Effect of combined physical exercise on inflammatory markers and the relationship with body composition in young women

ObjectivesTo evaluate the effect of eight weeks of combined physical exercise of moderate intensity on inflammatory markers, as well as its relationship with body composition in young women recently admitted to a Public Institution of Higher Education. MethodsLongitudinal, intervention study, in which 59 female participants aged 18–25 years were evaluated before and after a combined physical exercise program for eight weeks. Blood samples were collected before and after the intervention for analysis of C-reactive protein and inflammatory cytokines. Weight and height were measured to calculate body mass index and body composition was evaluated by Dual Energy X-Ray Absorptiometry before and after the intervention. Statistical analyzes performed were t-test, Willcoxon test and Spearman's correlation. This study was approved by the Human Research Ethics Committee and the Free and Informed Consent Form was signed by all participants. ResultsAfter the intervention, there was a reduction in the pro-inflammatory cytokines (IL-1β, IL-6, TNF and IL-12), while the anti-inflammatory (IL-10) and CRP did not change; reduction in the total body gynoid fat mass and in the percentage of body fat; increased trunk and total muscle mass. Body composition was negatively correlated with the pro-inflammatory interleukins IL-1β and IL-6 and positively correlated with CRP. ConclusionsCombined physical exercise for eight weeks acted to reduce pro-inflammatory cytokines, fat mass and increase in muscle mass. Inflammatory markers correlated with body fat before the intervention, suggesting the participation of visceral adipose tissue in the release of these markers in female university students.