Clinical Research Directory

Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT

Lack of patient knowledge about ECT (electroconvulsive therapy) is a leading cause of treatment fear with 60% of ECT patients reporting high levels of anxiety. The purpose of this study is to determine if using Virtual Reality (VR) to allow patients' to experience a virtual ECT education session before treatment is useful in lowering treatment anxiety and increasing knowledge about ECT if compared to standard treatment. In addition, measuring heart rate and blood pressure levels before ECT treatment will allow us to assess changes in anxiety levels. Individuals who choose to participate will be placed (participant will have a 50% chance to be placed in either group) to view either a virtual reality video to experience a virtual ECT session, or to receive standard preparation, i.e. a discussion with a psychiatrist. Before and after this session participants will be asked to complete a measurement of their anxiety level and knowledge about ECT (ECT Attitude \& Knowledge Questionnaire). Just before ECT treatment, blood pressure, heart rate and anxiety level will be measured. Participants will also complete cognitive and depression assessments. This study will help to develop a relationship between healthcare providers and patients and their families to help with education before ECT treatment.

#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.

The #aware.hiv Europe study is a real-world, multicenter, stepped-wedge cluster randomized, effectiveness-implementation trial designed to evaluate whether the introduction of dedicated HIV teams in hospitals can improve HIV testing rates among patients presenting with HIV indicator conditions across ten European countries. Study Design: The study employs a stepped-wedge design, whereby clusters of hospitals transition sequentially from a control phase (routine care) to an intervention phase. All patient data are collected retrospectively from routine care, while prospective data are gathered at the healthcare professional level. The project spans four years and involves hospitals from the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. This design allows for comparison of HIV testing rates and related outcomes before and after the implementation across different settings and time points. Intervention: The core intervention involves the establishment of hospital-based HIV teams. Each team is led by an HIV specialist and supported by nurses and data collectors. Their responsibilities include: Identification and Surveillance: Screening routine electronic health records for HIV indicator conditions using predefined ICD-10 codes and verifying cases that warrant HIV testing. Audit \& Feedback: Providing targeted recommendations to treating physicians when an HIV test is indicated but has not been performed, thereby prompting action. Education \& Training: Delivering training sessions to healthcare professionals to improve their knowledge and attitudes towards HIV testing, prevention, and care. Enabling Environment: Implementing digital solutions and other support mechanisms to streamline testing processes, reduce stigma, and enhance overall guideline adherence. Linkage to prevention: Improving linkage to the locally available preventive services. The intervention is intended to integrate seamlessly into routine hospital care, thereby reinforcing existing guidelines while addressing the current diagnostic testing gap. Endpoints and Outcome Measures: Primary Endpoint: The change in HIV testing rate among patients diagnosed with HIV indicator conditions before and after the implementation of HIV teams. Key Secondary Endpoints: The change in the incidence of new HIV diagnoses among patients with HIV indicator conditions. Variations in HIV testing rates across different countries, medical specialties, and types of indicator conditions, as well as over time. Assessment of the cascade of HIV diagnosis, including the proportion of patients identified with an indicator condition, the offer and acceptance of HIV testing, and documented reasons for non-testing. Evaluation of the cascade of HIV care and prevention, including linkage to HIV care, achievement of viral suppression, and referral and uptake of preventive services. Changes in healthcare professionals' knowledge, attitudes, and levels of stigma towards HIV. Implementation outcomes such as fidelity of HIV team activities, resource utilization, cost-effectiveness, and sustainability of the intervention. Analysis of contextual factors, barriers, and facilitators impacting the implementation process, using established frameworks like CFIR and RE-AIM. Impact: By introducing HIV teams and systematically monitoring their effect on HIV testing practices, the study aims to enhance early HIV diagnosis and improve patient outcomes. The findings will contribute to evidence-based guidelines and may promote the adoption of similar interventions across European healthcare settings, ultimately reducing HIV-associated morbidity, mortality, and transmission rates. This project not only addresses a critical diagnostic gap in HIV care but also provides valuable insights into the effective implementation of complex interventions in routine clinical practice.

Simulation-Based Team Training for Management of Local Anesthetic Systemic Toxicity (LAST) in Non-Anesthesiologist Surgical Residents

This randomized controlled trial evaluates the effectiveness of a simulation-based multidisciplinary team training program on the management of Local Anesthetic Systemic Toxicity (LAST) among non-anesthesiologist surgical residents. Guided by Kirkpatrick's evaluation model, the study investigates improvements in knowledge, technical and non-technical skills, and the retention of these competencies one month after training

Musicians' Health Education in D-A-CH

Professional musicians are often exposed to significant physical and psychological strain. Long hours of playing, high muscle tension in the head and neck area, and performance-related stress can lead to problems such as musculoskeletal pain, jaw joint disorders, facial pain, and reduced oral health. Although these health issues are common, preventive strategies and structured health education are often insufficiently integrated into music training programs. This study aims to assess how topics related to musicians' health and performing arts medicine are currently included in the curricula of music universities in Germany, Austria, and the German-speaking part of Switzerland (D-A-CH region). Professors and lecturers responsible for musicians' health or curriculum planning at 39 music universities will be invited to complete a short questionnaire (approximately 10 minutes). The survey collects information about whether and how health-related topics are taught, including whether they are mandatory or elective, their duration, and the specific subjects covered. This is a non-interventional survey study. No medical examinations or treatments will be performed. Participation consists solely of completing the questionnaire. The results will help identify gaps in health education for professional musicians and support the future development of preventive and educational programs.

Online Watch-Summarize-Question-Ask Method in Falls Education for Nursing Students

This randomized controlled study will evaluate the effectiveness of an online Watch-Summarize-Question-Ask (WSQA) learning method on nursing students' knowledge, skills, attitudes, and behaviors related to patient fall prevention and management. Sixty-six nursing students will be randomly assigned to intervention and control groups. Both groups will receive standard patient safety education, while the intervention group will additionally participate in an online, evidence-based fall prevention training program structured according to the WSQA method, including video-based learning, summarization, question generation, and interactive discussions. Outcomes will be assessed using validated instruments measuring fall management knowledge, self-efficacy, attitudes toward fall prevention, care planning performance, and student satisfaction. The study aims to determine the effectiveness of an innovative educational approach to improve fall prevention competencies and enhance the quality and safety of nursing care.

The Effects of Face-to-face and Tele-nursing Education on Fatigue, Pain, Sleep, and Urinary Tract Infections in Patients With Multiple Sclerosis.

The aim of this study is to evaluate the effects of face-to-face and distance nursing education, based on Pender's Health Promotion Model, on fatigue, pain, sleep, and urinary tract infections in MS patients who applied to the Multiple Sclerosis Outpatient Clinics of Sakarya Training and Research Hospital. With this research, the researcher aims to reduce MS symptoms and severity, prevent secondary problems, and improve quality of life.

AI-Generated Video Feedback to Improve Technical Skills in Coronary Artery Bypass Grafting

This study aims to evaluate whether targeted video feedback generated by an artificial intelligence (AI)-based surgical performance assessment model can support improvement in technical skills among cardiac surgeons performing coronary artery bypass grafting (CABG). This is a single-group, self-controlled, pre-post interventional study. Participating surgeons will submit a baseline CABG surgical video, which will be assessed by both an AI model and blinded human expert raters using standardized scoring criteria. Based on the AI assessment, surgeons will receive personalized video feedback highlighting operative steps associated with lower technical performance. After a one-month self-directed review period, a follow-up CABG surgical video will be submitted and evaluated using the same process. Changes in human-rated technical skill scores between baseline and follow-up will be used to assess the potential educational impact of AI-generated video feedback.

The Effectiveness of Gamified Scenario-based Teaching in Improving Nurses' Awareness and Confidence in Clinical Emergency Care

Research Objective: This study aims to explore the effectiveness of gamified situational teaching in improving nurses' awareness and confidence in clinical emergency response.

Flipped Learning in Nursing Education

This study aims to examine the effects of cancer screening training, conducted using a ChatGPT-based flipped learning model, on knowledge, learning motivation, and class participation.

Determining the Effect of Midwife-Led Safe Infant Care Training for Pregnant Women on Awareness of Sudden Infant Death Syndrome and Home Accidents

This project is a pioneering study in determining the impact of midwife-led safe infant care training for pregnant women on awareness of sudden infant death syndrome (SIDS) and home accidents. Raising awareness and improving women's knowledge about SIDS and home accidents is expected to help reduce preventable infant deaths. If the effectiveness of this training is proven, integrating it into prenatal care programs would be a significant step towards improving maternal and child health.

Effect of E-learning Training on National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) Assessment

The goal of this web-based randomized clinical trial is to evaluate whether an e-learning training program improves the accuracy of National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) assessments among practicing paramedics in French-speaking Switzerland who have not previously received formal training in these scales. The main questions it aims to answer are: * Does e-learning training improve performance on a standardized NIHSS assessment quiz compared with no prior training? * Does e-learning training improve the accuracy of mRS assessment using case-based clinical vignettes compared with no prior training? Researchers will compare paramedics who complete the NIHSS and mRS e-learning modules before assessment (intervention group) with paramedics who complete the assessments without prior training (control group) to determine whether e-learning training leads to higher assessment performance scores. Participants will: * Provide electronic informed consent via a secure web-based platform * Be randomly assigned to either the intervention group or the control group * Complete either the e-learning modules before assessment or the assessments before training, depending on group allocation * Complete an online NIHSS quiz and mRS case-based vignettes * Receive access to the NIHSS and mRS e-learning modules by the end of the study

Jigsaw Technique and Stroke Patient Care

In the literature, problem-based learning, case discussions and case scenarios, and simulation applications are used in stroke patient care nursing education. However, the use of the jigsaw technique is quite limited. Based on this information, it is anticipated that stroke patient care education provided with the Jigsaw technique can increase nursing students' cooperation and communication skills, allowing them to acquire more effective and comprehensive knowledge in clinical care.

The Effect of Mobile Devices on the Development and Health of Young Children

Interactive electronic devices (IEDs) have become a common part of young children's lives, yet research on this topic remains limited. Most studies utilise cross-sectional designs and present inconsistent evidence regarding the benefits and harms of IED use. Some findings suggest that IEDs may negatively impact sleep quality, be linked to visual impairment, and lead to reduced and more negative interactions between parents and children. However, it might also have a positive effect in helping language learning in young children when IEDs are co-viewed with parents and improving literacy, mathematics and science skills. Due to this conflicting evidence, health guidelines for young children do not provide specific recommendations on using these devices, leading policymakers to request more information in this area. In conversation with parents and nursery practitioners, they told us they were confused about the benefits and hams of using these devices and wanted further guidance. The primary aim of this study is to investigate the long-term association between IED use (duration and mode) and development outcomes in 3-to-5-year-old children. The researchers will also explore the longitudinal association between IED use (duration) and other outcomes, including BMI z-score, movement behaviour, motor skills, parent-child interaction and school readiness. Children and their parents or caregivers from both low, mid and high-income areas in England will be invited to take part. Children can participate if they are between 3 and 4 years old when they join the study, have received consent from their parent or caregiver, and have provided verbal agreement to participate. However, children will not be eligible if their parents or caregivers do not speak or understand English or if the child has been diagnosed with a developmental disorder by a medical professional before the baseline or follow-up measurements. Data collection will occur at the start of the study and one year later when children are 4 to 5 years old. Parents will be asked to download an app called EARS on the smartphone and/or tablet that the child uses. The app will measure how long they use the device (IED duration) and the specific apps accessed during device usage (IED mode). Child development will be assessed through the following measures: 1) working memory, including visual-spatial and phonological aspects; 2) ability to control, referred to as inhibition; 3) the ability to control and redirect attention, defined as shifting; 4) self-regulation; 5) social development; 6) numeracy skills; and 7) expressive vocabulary. Child development will be measured using the Early Years Toolbox app and recorded on an iPad. The researchers will also measure a set of secondary outcomes, including 1) BMI z-score; 2) 24-hour movement behaviour (i.e. physical activity, sedentary behaviour and sleep); 3) motor development (i.e., gross motor skills and fine motor skills); 4) parent-child interaction; 5) school readiness. The researchers will also measure other things that might influence IED use or emerging abilities, such as participants' demographics (i.e., sex, age, ethnicity and caregiver education), parenting styles, parents' smartphone addiction, the presence of screen viewing policy at the early year's settings. To thank the early years settings for participating, each will receive £100 for every data collection session. Parents will receive a £30 high street e-voucher for each data collection session in which they participate. There are no risks of physical injury or harm involved in this study. All researchers entering the nursery will have been subject to an enhanced Disclosure and Barring Service (DBS) check and are permitted to engage in controlled activity. If the research team observes a significant developmental delay in the child while conducting the health and development measures, they will notify the nursery staff, who will then communicate this information to the parents. Parents may feel uncomfortable downloading the app (EARS) onto their electronic devices to track how long the device is being used and the type of apps in use. The app has been designed for research purposes and approved by Sheffield Hallam University Digital Technology Services. Participants will download the app through the official Apple or Google Stores, which offers additional security and convenience. Participants will be advised to delete the app after each data collection point. The investigators will have regular group meetings throughout the project with parents, carers, nursery teachers and policymakers to gather ideas and opinions and share our findings. These discussions will help researchers improve the project. The findings will help inform public health guidance on children's device usage. The researchers will share the knowledge gained from this study with all participants, write policy briefs and scientific papers, and present the findings at conferences.

Effect of Preoperative Individualized Education on Anxiety and Recovery.

Researchers aim to investigate whether individualized preoperative education for patients is beneficial in reducing perioperative anxiety, promoting postoperative recovery, and enhancing postoperative quality of life. The educational content will cover aspects such as the surgery procedure, anesthesia, postoperative pain and anxiety management, recovery time, and any potential required treatments. All participants will be administered a questionnaire before the surgery to evaluate their specific concerns and fears. The intervention group will receive preoperative education through audio-visual materials followed by targeted preoperative counseling, while the control group will receive routine preoperative education.

Effectiveness of an Early Reading Intervention for Young Children With Intellectual Disabilities Who Need or Use Augmentative and Alternative Communication

The goal of this 2x2 factorial randomized controlled trial is to evaluate the effectiveness of two literacy interventions delivered at different time points, in kindergarten and in first grade, on the development of literacy skills in children with intellectual disabilities who require augmentative and alternative communication. The main questions it aims to answer are: * Does early intervention in kindergarten lead to greater improvements in phonological and phonemic awareness, vocabulary, and articulation compared to training as usual? * Does a follow-up intervention in first grade enhance decoding skills and sight word recognition beyond the gains achieved through the kindergarten intervention alone? * Does phonological awareness at the end of kindergarten mediate the relationship between early intervention and later outcomes in vocabulary, articulation, and decoding? * Do children who receive both interventions perform better than those who receive only one or none (training as usual), suggesting a cumulative or higher-dose effect? Researchers will compare four arms formed through a 2x2 factorial design after randomization to see if whether timing, combination, and sequencing of interventions produce differential effects on literacy outcomes. Participants will: * In kindergarten receive either an early literacy intervention or training as usual. * In first grade receive either a follow-up literacy intervention or training as usual, depending on group allocation. * Be assessed at key time points in both years, measuring phonological awareness, phonemic awareness, vocabulary, and articulation in kindergarten, and expanding to include decoding and sight word recognition in first grade.

The Effect of a Gender Education Program Based on the Com-B Model Developed for Newlywed Couples and Home Monitoring on Individuals and Families

Introduction and Aims: The family, recognized as the smallest and most powerful social unit that forms society, is an arena where gender roles, gender identities, and inequalities are reproduced and developed. The establishment, maintenance, and continuation of a healthy marriage is the source of healthy families and, naturally, healthy individuals. Therefore, research on newly married individuals is valuable as it sheds light on future generations. This research began with the question, "How should effective gender education be designed to minimize gender inequality and the problems arising from it?" This research presents a study protocol to evaluate the effectiveness of a gender education program based on the Capacity, Opportunity, and Motivation to Behave (COM-B) model. Furthermore, this study aims to take solid steps in the first stage of family formation through a one-year follow-up of newly married couples and thus create healthy and strong families. Method: This study will be conducted as a two-phase, prospective, single-center, two-group (1:1) parallel design, pre-test-post-test randomized controlled trial. The Capacity, Opportunity, and Motivation Behavior (COM-B) model is a theoretical framework consisting of six components to understand and support behavior change. In the first phase, a gender education program based on the COM-B model (COMBTC) will be developed, and in the second phase, the effectiveness of COMBTC will be evaluated with 100 newly married couples. The sample will consist of 100 couples who have been married for no more than one month and live in central Şanlıurfa, divided into intervention and control groups at a 1:1 ratio. Participants in the intervention group will undergo a 3-week, multi-component education program based on the COM-B model, while participants in the control group will receive routine general advice. Assessments will be conducted at baseline, after the education, and at 6-11 months. Research data will be collected using a personal information form, a healthy family scale, a marital role expectations scale, a marital problem-solving scale, and a family harmony scale. The data will be evaluated using descriptive statistical analyses and relevant tests.

The Effect of Wound Care Education Given to Patients on Wound Care Knowledge, Self-Care Self-Efficacy, and Quality of Recovery

This study will be conducted as a randomized controlled trial to determine the impact of artificial intelligence-assisted wound care training provided to patients undergoing prosthetic surgery on their wound care knowledge, quality of healing, and self-care self-efficacy. It was planned to include 22 individuals in the experimental group and 22 in the control group. However, considering the potential for data loss, the study was planned to be completed with a total of 50 individuals: 25 in the experimental group and 25 in the control group. Patient Identification Form, Patient Follow-up Form, Knowledge Level Questionnaire, Self-Care Self-Efficacy Scale and Quality of Recovery (QoR-15) Scale were used to collect data.

Clean Beauty in Newark, NJ

Every day, consumers use personal care products containing thousands of manmade chemicals. Growing evidence suggests that personal care products specifically marketed to Black women (e.g., hair straighteners and oils, skin lighteners) often contain potentially hazardous chemicals that can interfere with hormones or increase cancer risks. This research focuses on how the investigators can educate and activate community members in Newark, NJ to reduce disparities in exposures occurring through hair products. Leveraging educational clean beauty events hosted by collaborators at Clean Water Action, the investigators will administer surveys on hair product use and attitudes immediately before and after a clean beauty educational intervention. Participants will also complete surveys 3 months post-event to examine any changes in attitudes or behaviors around hair products and their use and safety.

Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients (Cardio2U Study)

This trial has to aim to evaluate an innovative, in-house developed mobile application supporting patients in their home environment by actively involving them in different aspects of their condition and treatment. The usability, long-term adherence and patient satisfaction will be studied in patients with atrial fibrillation (AF) and/or heart failure (HF).

The Impact of Elderly Simulation Experience on Aging Knowledge, Attitudes, Empathy, Communication Skills and Learning Satisfaction for Facility Care- Workers in Long-term Care Institutions : An Action Research and Effectiveness Evaluation

This study aims to evaluate the effectiveness of an aging simulation experience course in enhancing the aging knowledge, care attitudes, empathy, communication skills, and learning satisfaction of care service personnel working in residential long-term care institutions.

The Role of Simulation-based Training in Resident Curriculum in Anaesthesia and Intensive Care

This observational study aims to describe the situation in Europe regarding simulation training during residency in Anaesthesia and Intensive Care. The main questions it aims to answer are: How many countries in Europe have obligatory simulation training during residency? How frequent is this training? What and how is trained during simulations? How is the situation regarding funding and participation in working hours in simulation training? What are the obstacles for the countries that do not have obligatory training? Participants will fill out an electronic survey.

Ahi-Based Education on the Professional Values of Nursing Students

In current nursing education programs, professional values education mostly remains at a theoretical level; students' internalization of these values and reflection of them in their behavior is limited. Ahilik is a historical system based on ethical principles, professional responsibility, and a sense of service to society. The aim of this study is to experimentally evaluate the effect of Ahilik-based education on the professional values of nursing students. Hypotheses H0: There is no significant difference between the professional values of nursing students who receive Ahilik education and those who do not. H1: The professional values of nursing students who receive Ahilik education are significantly different from those who do not.

How Digital Media Affects Kids' Healthcare Experiences and Outcomes

The goal of this clinical trial is to learn whether different forms of media (2D, 360, or 360 in virtual reality) have different impacts on pre-procedural anxiety and post-procedural pain in children. The main questions it aims to answer are: Does one type (and richness) of media reduce pre-procedural anxiety and post-procedural pain more than another type of media? For example, will learning about an upcoming procedure by watching a 360 video in virtual reality reduce pre-procedural anxiety more than learning about the same upcoming procedure by watching it in a 2D video or 360 video? The second question is whether watching a 360 video in VR about an upcoming procedure more effective in reducing pre-procedural anxiety and post-procedural pain compared to the 2D video or the 360 video without VR groups for specific procedures? For example, is watching an explanation of a procedure in VR always more effective in reducing pre-procedural anxiety and post-procedural pain, or is it procedure specific (i.e., watching a video about surgery preparation is more effective in VR, but for cast removal it doesn't matter whether participants learn about their procedure viewed through VR, 360 video, or 2D)?

Childbirth Education Classes, Spousal Support, Birth Memory, Choice of the Birth Method, and Birth Satisfaction

The research questions of this study are listed below. 1. Is the mean spouse support score of pregnant women who attend childbirth preparation education with their spouses higher than that of women in the group with unique participation in childbirth preparation education and the control group who were left to usual care? 2. Is the mean birth satisfaction scale score of pregnant women who attend childbirth preparation education with their spouses higher than that of women in the group with unique participation in childbirth preparation education and the control group who were left to usual care? 3. Is the mean birth memory and recall scale score of pregnant women who attend childbirth preparation education with their spouses higher than that of women in the group with unique participation in childbirth preparation education and the control group who were left to usual care? 4. Are the birth preferences of pregnant women who attend childbirth preparation education with their spouses significantly different from those of women in the group with unique participation in childbirth prep