Treatment Trials

42 Clinical Trials for Various Conditions

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RECRUITING
Wellness of Osteopathic Medical Students Throughout Their Training (Well-COM)
Description

The Well-COM Research Project addresses a critical gap in our understanding of the holistic health of medical students, over the entirety of the medical school experience. While the rigorous demands of medical education and its effects on the well-being of medical students are well-documented, there is a lack of long-term study assessing the mental, physical, and metabolic health of medical students from entry into medical school through their training and into residency. By collecting holistic health data from new first-year medical students, and over a minimum period of 10 years, the Well-COM project aims to provide invaluable insights into the changes in health and wellness experienced by medical students, thereby informing future interventions and support systems to promote overall health and resilience in medical school students.

RECRUITING
Surgical Operating Room Enhancement Curriculum for Medical Students
Description

The goal of this clinical trial is to assess whether integrating an enhanced Surgical Operating Room (OR) curriculum into the medical student program improves knowledge and proficiency in gynecologic surgical techniques and procedures among medical students at Wayne State University. The main questions it aims to answer are: Does the Surgical Operating Room Enrichment Course increase medical students' knowledge and comfort with gynecologic surgical procedures? Does participation in the course improve students' clinical perceptions and management of gynecologic emergencies? Researchers will compare students who participate in the Surgical Operating Room Enrichment Course (intervention group) to those who complete the standard rotation (control group) to see if the enhanced curriculum leads to greater improvements in knowledge and clinical skills. Participants will: Attend virtual didactic lectures covering gynecologic anatomy, perioperative care, surgical techniques, and management of gynecologic emergencies Complete pre- and post-training surveys assessing knowledge, skills, and perceptions related to gynecologic surgery This study involves approximately 60 medical students, with participation being voluntary and all responses de-identified.

RECRUITING
Examining Executive Functions in Medical Students Across Different Types of Study Breaks
Description

This study aims to expand on previous findings and compare the effects of an active break (ten minutes of walking or upper body movement), a digital break (ten minutes of phone use), and no break on memory and attention in medical students after a prolonged period of studying. The List Learning Task, Stroop Test, and Sustained Attention to Response Task will be administered to measure memory, executive function, and attention, respectively. Information on how different types of breaks affect memory and attention may prompt medical students to be more mindful and intentional of the way they spend their time in between studying.

RECRUITING
Medical Student Firearm Safety Counseling Follow-Up Study
Description

The preclinical curriculum related to firearm violence and safety counseling at the UCLA David Geffen School of Medicine (DGSOM) has been expanded for the Class of 2027, informed by the results and conclusions of an initial study of firearm safety counseling by medical students (ClinicalTrials.gov ID: NCT05242627), which was conducted by the present study team. The 1-hour firearm safety counseling training session used in that study will be taught again to first-year medical students in the Class of 2027, but training will be augmented with additional instruction; the Class will receive additional comprehensive instruction on suicide risk assessment and will participate in small group breakout sessions, to facilitate the opportunity for students to discuss issues related to firearm violence as a public health issue and to practice firearm safety counseling with standardized patient actors (SPs). Assessment of access to firearms and firearm safety counseling will be added as a standard component of the Social History that students are taught to obtain from patients during clinical examinations. The goal of the expanded training is to increase the prevalence of medical student counseling when they are conducting a history and physical examination in a simulated patient encounter with an SP 6 months after the initial training session, when compared to results from the initial study. The scenario provided to the SP will be identical to that used in the initial study and is a situation in which firearm safety counseling is warranted. Students will participate in a survey to ascertain their knowledge of firearm violence and their attitudes about physician counseling about firearm safety, prior to formal instruction. Informed consent will be obtained from students to use their responses in educational research. Following the didactic and small group sessions, students will be asked to complete a post-training survey that is similar to the original survey, as a means of assessing knowledge gained and any change in attitudes about physician counseling. The simulated patient encounter will occur approximately 6 months later, after which students will complete another survey to determine retention of knowledge and their experience during the simulated patient encounter. Students will not be told before the encounter that they will be evaluated regarding firearm safety counseling. The SP will identify which students did and did not raise the issue of firearm safety. Videos recorded of each students' sessions (routinely obtained for grading purposes) will be viewed by investigators for those students who provide informed consent, to determine the quality of counseling, if it was conducted. Results from this follow-up study will be compared to the results of the initial study as a historical control, to determine whether augmentation of firearm safety counseling training above a 1-hour didactic session increases firearm safety counseling by medical students in a clinical setting and whether it improves retention of knowledge about firearm violence.

COMPLETED
Investigating the Effects of Osteopathic Manipulative Treatment on Stress Management in Medical Students
Description

The goal of this clinical trial is to evaluate stress biomarkers, subjective stress levels, and cognitive function in medical students. The main question\[s\] it aims to answer are: Does regular osteopathic manipulative treatment affect stress in medical students? Does regular osteopathic manipulative treatment affect cognitive function in medical students? Participants will be split into two groups, control and treatment, and undergo a designated protocol for six weeks. The treatment protocol will include weekly sessions of three OMT techniques: paraspinal inhibition, rib raising, and condylar decompression. Concurrently, participants' salivary cortisol levels will be collected weekly and analyzed using an Invitrogen ELISA Immunoassay Kit. Additionally, cognitive function will be assessed weekly via Lumosity, while stress levels are gauged using the College Student Stress Scale (CSSS) survey. Researchers will compare one cohort of medical students who receive weekly OMT and another cohort of medical students who have weekly check-ins without OMT to see if OMT can affect changes in stress biomarkers, subjective stress scales, and cognitive function.

RECRUITING
Resilience, Grit, and Stress in Medical Students
Description

The incidence of burnout and mental ill-health begins very early in medical school and continues to be high throughout training. Medical students are under high amounts of stress, which often becomes chronic, and can lead to both physical and psychological issues as a student, resident, and physician. Chronic stress and burnout in medical students are not a new phenomenon, but recent research has highlighted the worsening mental health of medical students, with as high as three-quarters of students reporting mental ill-health. It is vital that ways are found to reduce burnout and assist in improving the mental health of medical students. This quasi-experimental study is an ongoing study which is enrolling cohorts of students as they enter medical school.

COMPLETED
Effects of Family Status of Osteopathic Medical Students on Their Perceived Level of Stress.
Description

The investigators are interested in studying the effects of familial obligations, including marriage, parenthood, familial caregiving, on stress levels in Osteopathic Medical Students (OMS). The investigators expect to find that having a family may increase the stress level of OMS in comparison with OMS who don't have familial obligations.

COMPLETED
Outcomes of a Small Process Group on Medical Students' Grit, Resilience, and Stress
Description

The incidence of burnout and mental ill-health begins very early in medical school and continues to be high throughout training. Medical students are under high amounts of stress, which often becomes chronic, and can lead to both physical and psychological issues as a student, resident, and physician. Chronic stress and burnout in medical students are not a new phenomenon, but recent research has highlighted the worsening mental health of medical students, with as high as three-quarters of students reporting mental ill-health. It is vital that ways are found to reduce burnout and assist in improving the mental health of medical students. This quasi-experimental study aimed to assess the effect of a small process group vs. a control group of preclinical medical students on their stress, resilience, and grit.

Conditions
UNKNOWN
Characterization of Medical Student Burnout Using Remote Physiologic Monitoring
Description

A reliable method for monitoring stress and burnout among medical students is critically needed. To address this gap, our team aims to utilize the cost-effective WHOOP strap 4.0 wearable device to continuously capture stress-relevant physiologic data (i.e., sleep hours, heart rate variability, respiration rate, resting heart rate) among up to 50 third-year medical students at 24 Sidney Kimmel Medical College at Thomas Jefferson University for 6 months.

UNKNOWN
Intervention to Reduce Serious Mental Illness and Suicide Stigma Among Medical Students
Description

The team aims to develop and test the efficacy of a serious mental illness (SMI) and suicide ideation and attempt (SIA) stigma reduction intervention for medical students. The team expects that after intervention exposure, relative to control group, participants in the experimental condition will manifest more favorable change in knowledge, attitudes, and behaviors.

ACTIVE_NOT_RECRUITING
Firearm-Safety Counseling: Medical Student Training
Description

In the United States, nearly one in every three households contains at least one firearm, and roughly 20-25% of American adults personally own a firearm. Such easy access to firearms is a major contributor to the uniquely high levels of firearm-related violent death in the United States compared with other high-income nations. American physicians are intimately aware of this burden and are positioned to help modify the risks that firearms pose to the health and safety of their patients. Accordingly, it is imperative that physicians learn both how to screen their patients for exposure to firearms and how they can effectively counsel those who are at an increased risk for firearm-related injury on how they might reduce that risk. Until the 2021-2022 academic year, the David Geffen School of Medicine (DGSOM) at the University of California, Los Angeles (UCLA) did not include in its medical school curriculum a firearm-safety counseling module; the only information pertaining to firearms had been a narrow-in-scope "Clinical Pearl," which gave statistics on the increased risk for fatal injury that firearms pose in the setting of domestic violence. Beginning with the incoming Class of 2025, DGSOM will implement a new curriculum, and the Curriculum Re-design Committee has incorporated a module offering instruction on how to screen for exposure to firearms and counsel patients on firearm-safety. This inclusion follows a pilot module on firearm safety counseling that was presented to the Class of 2023. The current trial will take advantage of these unique circumstances to evaluate the effects of introducing such a module on medical students' attitudes, beliefs, and behaviors related to firearm-safety counseling in the clinical setting. The performance of students in the Class of 2023, who did not receive training, will be compared to that of students in the Class of 2024, who did receive training, during a standardized patient encounter. The high prevalence of firearms in the US demands that physicians have a working knowledge of how to screen patients for exposure to firearms, and an ability to counsel those who have such exposure on firearm-safety. While physicians believe they should have an active role in screening for risk factors of firearm violence and counsel on firearm safety, experience indicates that they fail to do either routinely. Importantly, physicians cite a lack of training and self-confidence as the major factors preventing them from screening for, and counseling on, firearm safety. A recent study of third-year medical students showed that those who completed a brief (20 minute) module on firearm injury prevention (compared with those who did not) were more likely to report increased self-perceived ability to counsel patients on firearm injury prevention, both immediately and 6 months post intervention; however, the study failed to demonstrate a difference in long-term clinical behavior, suggesting more rigorous training methods are warranted. The investigators hope that educational modules supplemented with simulated patient interactions designed to allow students the opportunity to practice firearm-safety counseling will increase their propensity for engaging in these conversations in the future. The first innovative aspect of our proposal is that it is introducing an educational module which combines didactic lectures, interactive case-based discussions, and interviews with standardized patients. On a computerized literature search, the investigators found no evidence that such a comprehensive module has been studied. Furthermore, unlike previous studies which have either focused on immediate self-reported confidence or self-reported clinical encounters, the investigators' proposal intends to assess long-term retention of the module content by observing students' clinical practices in an OSCE 6 months after the module is taught. The investigators hypothesize that an educational module will significantly increase both the proportion of second-year medical year students who screen for firearms and the quality of firearm safety counseling.

COMPLETED
The Effect of Counterstrain Technique on Muscle Stiffness and Pain on Trapezius Tender Points in Medical Students
Description

Medical students are prone to developing neck pain due to prolonged studying and poor posture. This can manifest as tender points in the upper trapezius region. Counterstrain (CS) is an osteopathic manipulative technique that has shown efficacy in previous studies in treating tender points. The MyotonPRO is a myotonometric device that can be used to measure various muscle parameters such as muscle stiffness. There is limited research regarding the use of osteopathic manipulative medicine to produce measurable changes in muscle stiffness by the MyotonPRO. This educational study aims to establish the efficacy of CS technique in decreasing the pain level of upper trapezius tender points in medical students as well as determining if CS causes a significant decrease in muscle stiffness in treated tender points as measured by the MyotonPRO. The investigators hope this educational study will encourage further studies on how osteopathic manipulative techniques affects the physiologic parameters of muscles.

COMPLETED
Summative Assessment of the BurntOut 3D Simulation With Medical Students
Description

Burnout is a common problem for medical students and is associated with stress-related health problems and also potentially affects the quality of care delivered to their patients. Among the health problems commonly associated with burnout are substance use problems, and alcohol is the substance most often misused. The purpose of the evaluation is to document whether an educational intervention incorporating aspects of virtual reality (VR) via a 3D online simulation experience prevents or improves the primary endpoint of burnout and the secondary endpoints of burnout-related factors in medical students. The investigators will also will evaluate student satisfaction with the intervention to determine if it meets our standard of success. The hypothesis is that the intervention will improve the primary clinical endpoint of burnout from pre-intervention to post-intervention as measured by the Maslach Burnout Inventory, a validated inventory that is widely used to measure burnout. The related factors that will be measured as secondary clinical endpoints include quality of life, substance use (alcohol and drugs), depression, and resilience. Due to evidence that these endpoints are linked to burnout, the investigators also hypothesize that the measures will improve pre- to post-intervention. Satisfaction of the target audience after completing the simulation intervention will also be evaluated. The evaluation will be prior to and after use of the simulation by medical student participants, using a pre-/post intervention, wait-list control, parallel design.

COMPLETED
Don't Throw Your Heart Away: Medical Student Study 2
Description

Publicly available outcome assessments for transplant programs do not make salient that some programs tend to reject many of the hearts they are offered, whereas other programs accept a broader range of donor offers. The investigators use empirical studies to test whether transplant center performance data (i.e. transplant and waitlist outcome statistics) that reflect center donor acceptance rates influence laypersons to evaluate centers with high organ decline rates less favorably than centers with low organ decline rates. 125 medical student participants will be recruited from University of Pittsburgh Medical School and randomized to one of two different information presentation conditions. Participants will be given an introduction to the donor organ match process, then asked to view the table of transplant outcomes corresponding to the condition they were randomized to. Each participant is asked to choose the hospital that they would consider to be "higher performing" between two hospitals: one hospital with a non-selective, "accepting" strategy (takes all donor heart offers), and one hospital with a more selective, "cherrypicking" strategy (tends to reject donor offers that are less than "excellent" quality).

COMPLETED
Preclinical Medical Student Echocardiography Training American Society of Echocardiography Curriculum
Description

The investigators would like to evaluate how well pre-clinical medical students are able to perform a basic transthoracic echocardiography examination on a healthy volunteer using a hand-held ultrasound (HHU) after completing a flipped classroom echocardiography training methods which consist of pre-training e-learning, hands-on training, and competency assessment after the hands-on training.

COMPLETED
Lifestyle Intervention Program in Overweight Medical Students
Description

This study will be a randomized cross-over design over the course of 2 academic years. 40 subjects -20 overweight women and 20 over weight men will be recruited. Each subject will have body composition tested, blood lipid profile, and resting metabolic rate done in the beginning of the first academic year and at the end of the first academic year. The intervention group will receive activity trackers, diet counseling, and fitness counseling for one academic year. The second year, all outcome measures (a body scan, blood lipid profile, and resting metabolic rate) will be performed again at the start of the academic year 2, except the intervention group will now be the control group and the control group will now receive the same intervention. All final outcome measures will be performed at the end of the second year.

Conditions
COMPLETED
Text4Peds: Short Message Service Evaluating Medical Student Education
Description

In this study, third year medical students on the pediatric clerkship will be randomized to receive either only written educational material (review journal articles) or written educational material plus daily text messages consisting of board style questions with online answers. The students' performance on the National Board of Medical Examiners (NBME) Pediatric Subject Evaluation will be compared between the two groups.

ACTIVE_NOT_RECRUITING
Pomegranate Supplementation and Well-Being Among Medical Students and Residents
Description

Medical students and residents have high rates of mental distress and burnout related to the intellectual and time demands of their training. Research shows that physiological stress on the body can be a result of fatigue and high stress work, and is associated with experiences related to mental distress. Pomegranate is a fruit that is known to contain a variety of antioxidant substances that can reduce physiological stress. This study will look at the potential for pomegranate supplementation to reduce physiological stress and improve well-being in medical students and residents.

COMPLETED
Simulation and Cadaver Workshop for Medical Students
Description

Background: The use of simulation and cadaveric laboratory training are highly beneficial for faculty and advanced trainees, but its usefulness for third-year medical students rotating through OB-GYN or general surgery is unknown. Objective: To determine if a two-day intensive, cost-effective review of procedural skills and anatomy using the simulation laboratory and cadaver-based dissection improves performance of third-year medical students on the National Board of Medical Examiners (NBME) Shelf and USMLE Step 2 board examination and during pre- and post-test demonstrations. Significance: If proven effective, implementation of a short, inexpensive, and comprehensive course highlighting anatomical and procedural skills during the third year of medical school could be implemented. Design Methods: The investigators will conduct a 1:1 randomization of third-year medical students rotating at all Mayo sites (Jacksonville, Rochester, and Scottsdale). The students will either participate in traditional education (N=20) as is currently taking place or traditional education plus cadaver-based/simulation-based learning (N=20). Third-year medical students rotating in OB-GYN or surgery will be eligible to enroll. Anticipated Outcomes: Knowledge-based examination results as well as performance outcomes will be improved and procedural skills and overall satisfaction will be increased.

WITHDRAWN
Impact of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes of Medical Students
Description

A qualitative study assessing the impact of early narrative medicine practice on Medical Honors Program (MHP) students' attitudes regarding patient-centered interactions, through interviewing patients with chronic or life-limiting illnesses to obtain their illness stories. MHP students will develop a patient narrative for the patients interviewed. These narratives will be edited by the patient, and, with the permission of the patients, may be published as a collection of stories.

COMPLETED
Feasibility and Efficacy Study of Student Wellness Online Course for Medical Students
Description

This study aims to investigate the feasibility and efficacy of online student wellness courses for improving medical student mental health and well-being.

COMPLETED
Fit Physicians: Use of Activity Monitors and Activity Integration Program in First Year Medical Students
Description

Using FitBit activity monitors, physical activity levels will be monitored in first year medical students. Body Composition will be measured as well.

COMPLETED
Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following a Dietary Supplement-based Intervention
Description

Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study extends an earlier study in which an increase in skin carotenoid scores (SCS) was observed in subjects who increased their intake of fruits and vegetables. The scores were determined using the Raman Spectroscopy. In that study subjects were assigned to one of four groups based on their baseline SCS. For unknown reasons, the groups with the highest and lowest baseline SCS failed to show an increase whereas the two intermediate groups did. One possible explanation might be that intakes varied more than expected and was not obvious due to self-reporting of intake of fruits and vegetables with different contents.

Conditions
COMPLETED
Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following Dietary Interventions
Description

Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study will use Raman Spectroscopy to examine the ability of increased dietary intake of fruits and vegetables to increase SCS in medical students. This will be an observational, non-invasive study examining skin carotenoid levels over time in individuals who have increased their intake by dietary adjustments. Thirty medical students meeting study inclusion criteria will be asked to increase their intake of high antioxidant fruits and vegetables to 4-6 cups per day over an eight week period of time. Students will self-select their fruits and vegetables from a given list and will receive supermarket gift cards to offset the cost of the increased food. Students will be asked to follow their usual diet for one week. Then increase their intake of high antioxidant fruit and vegetable to 4-6 cups per day for eight weeks. Then return to their usual diet for 2 weeks. SCS scores will be taken at baseline and week 1. At the beginning of week 2, students will be asked to increase fruit and vegetable intake to 4-6 cups per day. SCS will be measured every two weeks during the 8-week intervention phase. Students will return to their usual diet for 2 weeks and SCS will be measured at the end of that 2-week period.

Conditions
COMPLETED
Use of Theater to Invoke Empathy and Reduce Bias in Medical Students
Description

The effect of medical humanities on medical student bias and clinical management is unclear. This study characterized medical student attitudes toward obese individuals and whether reading a play employing empathic characters can modulate negative reactions.

COMPLETED
Use of a Training Video to Teach Medical Students About Health Literacy
Description

1. Briefly describe the purpose of this protocol: This study is designed to evaluate the effectiveness of an educational training video on the topic of health literacy for medical students. 2. Briefly summarize how participants are recruited: OHSU medical students attending mandatory trainings on the topic of health literacy during the 1st and 2nd years of medical school will be invited to participate in the study. 3. Briefly describe the procedures subjects will undergo: Completion of a short self-administered anonymous survey before and after viewing a 23-minute video about health literacy. 4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test questionnaire and 13-item post-test questionnaire designed to assess individuals' knowledge about health literacy, and intended clinical practices with respect to health literacy. 5. If this is a clinical trial using an experimental drug and/or device, or an approved drug and/or device used for an unapproved purpose, briefly describe the drug and/or device: n/a 6. Briefly describe how the data will be analyzed to address the purpose of the protocol: Demographics and responses to individual items will be reported as frequencies and percentages within the sample. The investigators will use a chi-square analysis to stratify responses by demographic groups and t-tests to measure possible changes over time.

Conditions
COMPLETED
Comparing the Effect of Video-cases and Text-cases on Medical Students' Learning in Tutorial
Description

This study is designed to examine how the type of learning case affects the thinking of medical students in tutorial

COMPLETED
Measuring Quality of Medical Student Performance at Contextualizing Care
Description

During the project, fourth-year medical students participating in a Medicine sub-internship will be randomized to an intervention group or a control group; the intervention group will receive additional training in the application of qualitative methodology to elicit and incorporate contextual factors in the clinical encounter. All students will participate in an SP assessment consisting of four standardized patients (SPs), blinded to trial arm, presenting cases with and without important biomedical and contextual factors in a counterbalanced factorial design. Performance will be compared between trial arms; the investigators hypothesize better performance in the intervention arm. In addition, performance will be compared with United States Medical Licensing Exam (USMLE) Step 2 clinical knowledge scores to determine whether contextualizing ability is independent of clinical knowledge, and consistency of performance across individual SP cases will be studied to determine the number of cases necessary to achieve sufficient reliability for the assessment to be used.

COMPLETED
The Psychosocial Effect of Thoughts of Personal Mortality on Cardiac Risk Assessment by Medical Students
Description

This study was designed to examine if provoking thoughts of mortality among medical students can influence cardiac risk assessments depending on the religion of the target patient.

Conditions
COMPLETED
Proficiency Based Robotics Training Curriculum: Skill Acquisition & Transferability of Skills to Live Porcine Models
Description

The goal of the project is to define the optimal learning environment and protocol for dvSS® simulation activities using medical students as robotic-naïve research participants.