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NCT07583082
Neurosurgery is a high-stakes surgical specialty where errors can result in significant patient mortality and morbidity. The amount of force applied on the brain simultaneously by the multiple different instruments during complex neurosurgical procedures is a critical safety metric that, to the investigators' knowledge, has not been previously measured in a realistic operative environment. The investigators have therefore developed a simulation platform integrating an ex vivo calf brain and a 3D-printed skull model attached to a force sensor capable of capturing real-time forces applied to the brain. A cross-sectional case series study will be conducted to evaluate the validity of the system. Medical students, neurosurgical residents, neurosurgical fellows, and staff neurosurgeons from four Quebec institutions will be recruited to perform three simulated subpial resections each using our ex vivo calf brain simulation platform. The forces applied by the microscissors, bipolar forceps, and ultrasonic aspirator onto the brain will be captured along with kinematic data. This study aims to establish the face, content, construct, and convergent validity of this ex vivo calf brain force detection system.
NCT07568574
Objectives: The primary objective is to assess the safety and tolerability of medical drugs with the potential to enhance performance (PES) in professional athletes over a 5.5 year period, encompassing a 25-week PES Exposure period and 5 year long term follow-up of period comprehensive health and safety monitoring. The secondary objective is to evaluate the impact of PES on athletic performance through validated sport specific and clinical assessments. Methods: This prospective hybrid design study will enrol 60 adult participants, divided into two groups. The first group will receive performance-enhancing substances (PES) directly through the study, administered as Investigational Medicinal Products (IMPs) under comprehensive medical supervision for up to 25 weeks. The second group will include natural athletes and those already using PES prescribed by their own doctors. All substances used in this study are medically approved by national regulatory agencies (e.g., FDA, MHRA, EMA, EDE, etc.), and market authorised. Participants undergo enrollment and baseline health and performance assessments, prior to a 25 weeks of PES exposure. During the period of PES exposure, participants undergo periodic monitoring of comprehensive physiological biomarkers alongside subjective assessments. Following the PES exposure phase, participants will complete repeat baseline health and performance assessments, followed by a titration phase and, where indicated, post-cycle therapy (PCT) to support the restoration of physiological function toward baseline. The study will conclude with a five-year longitudinal follow-up period to monitor long-term health outcomes. During this phase, participants will undergo annual assessments, including cardiac electrocardiography (ECG), echocardiography, magnetic resonance imaging (MRI), blood and urine biomarkers, routine vital signs, and quality-of-life measures. Additional imaging will include brain functional MRI (fMRI) and vital organ ultrasound at years 1, 3, and 5, with cardiac CT performed as clinically indicated. Athlete safety biomarker assessments, clinical evaluations, and adverse event reporting, will be continuously evaluated by study doctors and with additional safety oversight from a Data Safety Monitoring Board, Independent Medical Commission (a multidisciplinary panel of medical experts), and a Medical Monitor.
NCT07558070
This study aims to determine the effect of discharge education based on the Teach-Back method on patients' learning needs and readiness for hospital discharge following lower extremity surgery. Lower extremity surgeries are associated with pain, limited mobility, and decreased self-care ability, which may negatively affect recovery and quality of life. Effective discharge education is therefore essential to support postoperative recovery and continuity of care. This randomized controlled experimental study will be conducted with patients undergoing lower extremity surgery in an orthopedic clinic. Participants will be randomly assigned to an intervention group receiving Teach-Back-based discharge education and a control group receiving routine discharge education. Data will be collected at three time points (before the intervention, at discharge, and 15 days after discharge) using standardized instruments, including the Readiness for Hospital Discharge Scale-Short Form and the Patient Learning Needs Scale. The findings of this study are expected to contribute to improving discharge education practices, enhancing patient readiness for discharge, and reducing postoperative complications and unmet educational needs.
NCT07367906
This randomized controlled study aims to evaluate the effect of a patient safety-focused digital microlearning program on nursing students before they begin surgical clinical practice. Nursing students often face challenges related to patient safety and clinical decision-making during the transition from classroom learning to clinical settings. This study will examine whether short, structured digital learning modules can improve patient safety awareness, recognition of clinical errors, and decision-making skills. Second-year undergraduate nursing students will be randomly assigned to either a digital microlearning intervention group or a control group receiving standard education. Outcomes will be measured before the intervention, immediately after the intervention, and during the first week of clinical practice.
NCT07559422
This longitudinal, single-cohort, within-subjects study evaluates whether sequential exposure to Ventriloscope simulation stethoscope training, delivered after traditional auscultation instruction, enhances auscultation knowledge, clinical sound recognition skill, and self-reported confidence in Physical Therapy (PT) and Athletic Training (AT) students, and whether any enhancement is retained two months after training. All participating students receive both training modalities in sequence. Knowledge, skill, and confidence are measured at five timepoints (T1-T5) across approximately five months. A qualitative component examines student perceptions of the two training modalities.
NCT07545135
This is a pragmatic, cross-over randomized, two-group pre \& post-test experimental design aims to connect health discipline students from local and overseas countries to go through adventure-based escape rooms embedded with home setting scenarios.
NCT07543133
This randomized controlled study aims to evaluate the effect of simulation-based childbirth management training on safe motherhood practices and intrinsic motivation among midwives. Participants will be randomly assigned to either an intervention group receiving simulation-based training or a control group receiving no additional training. Outcomes will be assessed using validated scales before and after the intervention.
NCT07497971
This study looks at whether an interactive online education module can improve knowledge, comfort, and communication about sexual health during pregnancy. Many pregnant individuals experience changes in sexual function and intimacy but may feel uncomfortable discussing these topics or may have misconceptions about what is safe during pregnancy. Participants who are pregnant and receiving routine prenatal care will be randomly assigned to one of two groups. One group will complete an interactive, evidence-based educational module focused on sexual health and intimacy during pregnancy. The other group will review a standard educational article from the American College of Obstetricians and Gynecologists (ACOG) about sexual activity during pregnancy. Participants will complete surveys before and after reviewing the educational material, as well as a follow-up survey two weeks later. These surveys will measure knowledge about sexual health during pregnancy, comfort discussing sexual concerns with healthcare providers, and sexual function. The goal of this study is to determine whether an interactive educational approach can better support pregnant individuals' understanding of sexual health and encourage open communication with healthcare providers during pregnancy.
NCT07534982
This prospective randomized controlled trial evaluates the success of medical versus expectant management for retained products of conception (RPOC) following medical abortion with mifepristone and misoprostol for delayed miscarriage in the first trimester. Women aged 18-45 with sonographic evidence of RPOC (endometrial thickness \>10 mm with Doppler flow) will be randomized into two groups: medical management with misoprostol or expectant management (observation only). Follow-up will include ultrasound evaluations over six weeks to monitor uterine clearance and determine further interventions. Population: 150 participants, with 75 in each group. Inclusion Criteria: Stable women with RPOC after medical abortion, bleeding comparable to menstrual flow, and no fever. Exclusion Criteria: Hemodynamic instability, excessive bleeding, fever, or specific endometrial thickness criteria. Outcome Measures: RPOC resolution, need for surgical intervention, complications, and sonographic changes. Study Duration: Five years. Data on demographics, medical history, and ultrasound findings will be analyzed using SPSS, with results informing optimal management strategies for RPOC after first-trimester medical abortion.
NCT07528170
At St. Olavs Hospital, a prospective collection of data on complications related to CT-guided lung biopsies has been conducted over several years as part of quality control study. The primary aim of this quality control study is to map complications in all patients who have undergone percutaneous CT-guided lung biopsy at St. Olavs Hospital from May 2012 to December 2023.
NCT07522658
This prospective observational study aims to evaluate the effectiveness and educational value of artificial intelligence (AI)-generated multiple true/false questions compared to those developed by experienced academicians in anesthesiology training. A total of 27 anesthesiology residents will be included in the study. Question sets consisting of 200 multiple true/false items will be created, with half generated by academicians and the other half generated using an artificial intelligence model (ChatGPT-based system). The questions will be based on standardized educational materials from the anesthesiology training curriculum. Participants will complete the test in a single session. Each correct answer will be scored as one point, and total scores will be calculated. In addition to test performance, item difficulty, discrimination indices, and test reliability will be analyzed. Furthermore, participants' perceptions regarding question quality will be evaluated. The study aims to determine whether AI-generated questions can provide a reliable and effective alternative to traditional question development methods in medical education and contribute to more objective and standardized assessment processes.
NCT07524192
The goal of this clinical trial is to evaluate the preliminary effectiveness and acceptability of a self-instructional, web-based teacher training program designed to support the development of autistic children and children with developmental delays. This study aims to examine whether participation in the program can improve teachers' knowledge, attitudes, and teaching self-efficacy related to inclusive education and support for autistic children and children with developmental delays. The main questions it aims to answer are: 1. Does participation in the self-instructional program improve teachers' knowledge about autism and developmental delays? 2. Does the program improve teachers' attitudes toward inclusive education and their teaching self-efficacy? Researchers will compare teachers who participate in the self-instructional online intervention program (SEED program) with teachers who receive comparison educational materials (Kit for Kids from Organization for Autism Research) to determine whether the intervention leads to greater improvements in knowledge, attitudes, and teaching self-efficacy. Participants will: 1. Complete an online pre-intervention survey assessing background information, knowledge, attitudes toward inclusion and neurodiversity, and teaching self-efficacy. 2. Participate in a two-week self-instructional online program or receive comparison materials, depending on group assignment 3. Complete an online post-intervention survey evaluating the same outcomes, as well as program satisfaction and acceptability.
NCT06523907
Expected Significance of the Study: Improved Patient Outcomes: Paramedics often serve as the first point of contact for patients in primary healthcare settings. Ensuring that they possess adequate knowledge and skills in basic nursing care can lead to improved patient outcomes, including better management of chronic conditions, reduced incidence of complications, and enhanced overall quality of care. Enhanced Healthcare Delivery: By equipping paramedics with basic nursing care education, healthcare systems can optimize resource utilization and improve the efficiency of care delivery. Paramedics may be better equipped to handle a wider range of patient needs, reducing the burden on other healthcare professionals and streamlining the referral process. Addressing Skills Gaps: Many paramedics receive training primarily focused on emergency medical care rather than comprehensive nursing skills. This research addresses an important gap in paramedic education by evaluating the effectiveness of additional training in basic nursing care, potentially filling a critical need in the healthcare workforce. Professional Development: Providing paramedics with opportunities for ongoing education and professional development can enhance job satisfaction, increase retention rates, and contribute to a more skilled and competent workforce. This research could inform the development of training programs tailored to the specific needs of paramedics in primary healthcare settings. Cost-Effectiveness: Investing in education and training programs for paramedics may yield long-term cost savings for healthcare systems by reducing hospital admissions, emergency department visits, and unnecessary medical interventions. Assessing the effectiveness of such programs is crucial for allocating resources effectively and maximizing their impact. Evidence-Based Practice: By conducting a quasi-experimental study to evaluate the effectiveness of basic nursing care education among paramedics, this research contributes valuable evidence to the field of healthcare education and practice. Evidence-based findings can inform policy decisions, curriculum development, and clinical guidelines, ultimately benefiting both patients and healthcare providers.
NCT05701085
This study focuses on psychosocial barriers at the patient level with the goal of promoting high quality decision making around clinical trials participation. The proposed study adapts the PRE-ACT model to racial and ethnic minority patients who were underrepresented in the original PRE-ACT study and will be combined with a patient navigator model.
NCT07513636
This study aims to evaluate whether educating mothers can reduce screen time in infants aged 6-18 months. Early exposure to screens has been associated with potential negative effects on child development, including language delay, attention problems, and cognitive difficulties. Therefore, reducing screen exposure during infancy is considered important. The study is designed as an open-label, parallel-group randomized controlled trial. A total of 92 mother-infant pairs are planned to be included and randomly assigned to either an intervention group or a control group. Mothers in the intervention group will receive structured education based on recommendations from the American Academy of Pediatrics, including practical strategies to manage situations where screen use is commonly introduced (such as feeding or soothing the infant). Educational materials and follow-up guidance will also be provided. The control group will not receive any specific intervention. Data on infants' screen exposure will be collected at baseline and at follow-up visits at 3 and 6 months using structured questionnaires. Sociodemographic characteristics will also be recorded. The primary outcome of the study is the change in infants' screen time over the follow-up period. The findings are expected to provide evidence on whether parental education can be an effective strategy to reduce screen exposure in early childhood and support its integration into primary care practices.
NCT07500584
This study is a randomized controlled trial designed to evaluate the effectiveness of a structured psychodrama-based intervention on psychological well-being, empathy, self-compassion, and personality-related characteristics among undergraduate nursing students. The study will be conducted at the Faculty of Nursing, University of Foggia, Italy, with students enrolled in the Department of Medical and Surgical Sciences. Participants will be randomly assigned to either an intervention group or a control group using a computer-generated randomization procedure. The intervention group will participate in a structured psychodrama program consisting of ten weekly sessions, each lasting approximately two hours. The sessions will be conducted by a certified psychodrama therapist, following a structured framework aimed at enhancing emotional awareness, interpersonal skills, role-taking capacity, and psychological well-being. The control group will not receive any intervention during the study period and will continue with their routine academic activities. Data will be collected at three time points: baseline (pre-test), post-intervention, and a 2-month follow-up. In the pre-, post-, and follow-up assessments, the Positive and Negative Affect Schedule (PANAS), PERMA Profiler, Basic Empathy Scale (BES), Self-Compassion Scale (SCS), Emotional Contagion Scale (ECS), Rosenberg Self-Esteem Scale, and the HEXACO Personality Inventory will be administered. The primary aim of the study is to determine whether psychodrama intervention leads to significant improvements in psychological well-being and interpersonal functioning compared to the control group. Secondary outcomes include changes in empathy, self-compassion, emotional contagion, self-esteem, affective states, and personality traits. This study adopts a mixed factorial design (intervention vs. control × time), allowing for the evaluation of both short-term and sustained effects of the intervention. The findings are expected to contribute to the development of evidence-based educational and psychosocial interventions aimed at supporting the mental health and professional development of nursing students.
NCT07507123
This randomized controlled trial aimed to evaluate the effect of virtual reality-based discharge education on patients' readiness for hospital discharge after prostatectomy. Patients were randomly assigned to either a virtual reality-based education group or a control group receiving standard discharge education. The intervention provided immersive and interactive learning experiences to enhance patients' understanding of post-discharge care. Readiness for hospital discharge was assessed using a validated scale. It is anticipated that patients receiving virtual reality-based education will demonstrate higher levels of readiness compared to those receiving standard education. The findings may support the integration of innovative educational technologies into postoperative patient education to improve discharge outcomes.
NCT07036081
The goal of this observational study is to learn if tube-fed children and young people (age 3-15 years) find Wilbo's Blends+ (a new nutritionally complete enteral formula containing real food ingredients) acceptable, tolerable and easy to use. The main question it aims to answer is: Is Wilbo's Blends+ acceptable when included in the feeding plan of tube-fed children and young people (age 3-15 years) Participants will: Take Wilbo's Blend+ for a 7 day period as part of their feeding plan Complete questionnaires about their gastrointestinal symptoms
NCT06114433
This study aims to develop an upper body manikin with a high-fidelity upper gastrointestinal tract and apply into the nasogastric tube training program for nursing students.
NCT07417839
Goal To compare the effectiveness of a toy nebulizer versus distraction cards in reducing fear among children during nebulization therapy while improving parental satisfaction. Aim To evaluate and measure children's fear levels and parents' satisfaction when using toy nebulizers compared to distraction cards in nebulization sessions. Null hypothesis: (Hᴏ) There is no statistically significant difference in fear levels among children, and parental satisfaction scores in in the toy nebulizer, distraction cards, and control groups. Alternative hypothesis: (H₁) There is a statistically significant difference in fear levels among children, and parental satisfaction scores in the toy nebulizer, distraction cards, and control groups.