Clinical Research Directory

The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes

This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.

Adaptation and Evaluation of RESTORE

The purpose of this clinical trial is to test whether the RESTORE intervention works to reduce nurse burnout, by engaging nursing staff in system redesign to reduce job demands and increase job resources. Participants in the RESTORE intervention process will be interviewed about: * their experience with RESTORE * their experiences working on a unit where RESTORE was used Participants will also complete surveys of the impact of RESTORE on job demands, job resources, burnout, and work engagement.

Applying the ADDIE Model to Develop a Multimedia Program to Enhance Chemotherapy Knowledge and Self-Efficacy Among Intensive Care Unit Nurses

Research Methods, Procedures, and Participant Requirements: This study will test a multimedia interactive learning system designed to help nurses conveniently learn about chemotherapy drug administration. The study is scheduled to be conducted from November to December, 2025. Participants are expected to cooperate with the following procedures: Pre-test: Complete a questionnaire that includes basic demographic information and a self-efficacy scale. The estimated time for completion is about 10 minutes. System Experience: Use the multimedia learning system developed by the research team to study topics such as chemotherapy administration procedures, common error management, and side effect monitoring. The total learning time is approximately 30 minutes, and participants may use the system at their own pace-continuous use in one session is not required. Post-test: After completing the learning session, participants will fill out another questionnaire assessing learning outcomes, changes in self-efficacy, user experience, and system usability. This takes approximately 15-20 minutes. The total participation time is estimated to be 45-60 minutes. All responses will be collected anonymously. Participants may contact the research team at any time if they have questions or concerns, and assistance will be provided as needed.

Non-inferiority of Nurse-performed Versus Interventional Cardiologist-Performed Radial Catheterization in Elective Coronary Angiography: a Single-center, Open-label Randomized Trial.

Coronary angiography (or coronary arteriography) is a heart examination performed with contrast media to detect and treat coronary stenosis. The procedure involves the insertion of a catheter (a thin flexible tube) into a blood vessel in the groin (femoral) or arm (radial), which is then guided to the heart (cardiac catheterization). In some healthcare institutions, this medical procedure may be performed by a specially trained registered nurse (RN) under the supervision of an interventional cardiologist. Radial vascular access generally carries a low risk. However, complications such as hematoma, arterial dissection, or secondary occlusion may occur at the puncture site. Fluoroscopy is associated with a certain degree of radiation exposure. By acquiring skills traditionally within the scope of medical practice, Article 119 of Law No. 2016-41 of January 26, 2016, on the modernization of the healthcare system, created Article L. 4301-1 of the French Public Health Code, introducing the principle of advanced practice for allied health professionals. Since its implementation in July 2018, advanced practice has aimed to achieve two objectives: improving access to care and enhancing patient care pathways, while reducing physicians' workload in targeted conditions. A local cooperation protocol was submitted to the Regional Health Agency (ARS) on December 14, 2022. Since catheterization is considered a medical act, the submission of such a protocol is mandatory. This raises the question: Can radial catheterization, as a medical procedure, fall within the scope of advanced nursing practice under the supervision of an interventional cardiologist? A literature review on nurse-performed cardiac catheterization identified only one publication, in the journal HEART (1997). In this study, nurses from a cardiology department in Oxford, UK, performed the entire coronary angiography procedure. The study demonstrated that a specialized nurse with appropriate baseline experience could be trained to safely perform standard transfemoral cardiac catheterization procedures (including coronary angiography) in low-risk cases. There was no significant difference in performance (complication rates) between the nurse and cardiologists using the same angiographic facility. The risk of complication in catheterization and angioplasty is estimated at 1 in 1,000 in the literature. The above-mentioned study is the only one addressing our research question and showed no significant difference in complications between nurses and cardiologists. However, the benefit of radial access performed by nursing staff has not been established. Thus, the benefit-risk ratio for participants in our study remains unknown, though the risk is expected to be low, particularly as the procedure performed by the nurse is carried out under medical supervision. Furthermore, patients will be monitored for at least 8 hours post-procedure, with extended observation depending on clinical evaluation by the treating physician during hospitalization after randomization. Following discharge, patients will be reassessed at 3 months to collect outcome data and follow-up parameters. Nurses in the cardiology/ICU department are specially trained, with validation of several competencies. Only RNs who have acquired and validated the following eight competencies participate in the CATHE protocol: Competency 1: Knowledge of cardiology-specific diseases and care. Competency 2: Management of patients undergoing coronary angiography. Competency 3: Preparation of the coronary angiography suite. Competency 4 (part 1/2): Acquisition of knowledge and procedures specific to coronary angiography. Competency 4 (part 2/2): Acquisition of knowledge and procedures specific to cardiac catheterization activity. Competency 5: Assistance to the operator during the procedure. Competency 6: Management of adverse events occurring during the procedure. Competency 7: Development of professional behavior and skills related to coronary angiography. Competency 8: Performance of peripheral radial catheter insertion in the coronary angiography suite (within the framework of the local cooperation protocol and the CATHE study). Each competency is assessed and validated prior to participation. The primary objective of our study is to demonstrate that in France, an experienced and specially trained registered nurse can safely perform radial catheter insertion under the supervision of an interventional cardiologist. This does not involve femoral catheterization, nor nurse-performed coronary angiography as described in the earlier publication. The study is strictly limited to radial arterial catheterization.

Effects of Artificial Intelligence Nurse Orientation Program on Psychological Outcomes and Length of Hospital Stay in Intensive Care Unit

Artificial intelligence (AI), now an integral part of healthcare services and presents numerous opportunities. Customized treatment plans, clinical decision support systems, predictive analysis for disease prevention, patient engagement and education, quality improvement, and error reduction are some of these opportunities. In the context of delirium prevention, risk assessment, and treatment planning, the AI-supported system AI-AntiDelirium is designed to standardize the approach to delirium management in alignment with the PADIS guidelines. A randomized controlled trial evaluating the effectiveness of this system found that the workload of nurses decreased, facilitated early diagnosis and prevention of delirium, and recommended evidence-based and individualized delirium interventions. A systematic review concluded that AI applications did not significantly impact the length of hospital stay and emphasized the need for further research. Also, AI platforms contributed to positive results in reducing anxiety and depression in patients. Furthermore, systematic reviews have demonstrated that AI-based chatbots are effective in alleviating symptoms of depression and anxiety. However, the literature includes a limited number of patient education programs specifically designed to prevent or manage delirium through AI-based approaches. Notably, there is a lack of studies comparing the effectiveness of AI-supported educational interventions with those delivered directly by nurses. The goal of this clinical trial is to develop a structured AINurse and Human Nurse orientation training program for intensive care unit (ICU) patients and compare the effects of these training programs on ICU patients' delirium-free days, level of anxiety and depression, and length of stay in the ICU. Hypotheses of the study: H1: Patients who receive the structured AINurse patient orientation training program will have longer delirium-free days than patients who receive Human Nurse orientation training. H2: Patients who receive the structured AINurse patient orientation training program will have lower levels of anxiety and depression than patients who receive the Human Nurse orientation training. H3: Patients who receive the structured AINurse patient orientation training program will have shorter lengths of stay in the intensive care unit than patients who receive the Human Nurse orientation training. Researchers will compare the AINurse patient orientation training program and the orientation training program provided by human nurses in terms of patients' delirium-free days, level of anxiety and depression, and length of stay in the ICU. * Those in the intervention group will receive the AINurse orientation training program twice daily for 3 days. * Participants in the control group will receive face-to-face structured orientation training from researchers twice daily for 3 days. * Delirium-free day assessment, anxiety and depression will be evaluated for patients in both groups over 3 days. * The length of stay in the intensive care unit will be monitored for patients in both groups.

Interactive vs. Standard Video Education for Improving Outcomes in Hemodialysis Patients

The goal of this clinical trial is to find out if educational videos-especially interactive ones-can help people on dialysis better manage their treatment. Researchers want to answer the following main questions: Can interactive or conventional video-based education help patients better understand and follow their treatment plan? Does this type of education improve patients' ability to control their weight changes between dialysis sessions? Does this type of education improve patients' activation? Is interactive video education more effective than regular (non-interactive) video education? What Will Happen in the Study: Adults on hemodialysis will take part in the study. They will be randomly assigned to one of three groups: Group A: Will receive 10 interactive educational video sessions (30 minutes each). Group B: Will receive the same videos but in a non-interactive format. Group C (Control Group): Will receive routine education normally given at the dialysis center. Videos will be watched on a web platform. Interactive videos include pop-up questions and scenario-based feedback. All participants will be followed up immediately, 1 month, and 3 months after the program ends. What Participants Will Do: Watch educational videos over several days (totaling 5 hours). Answer questions and engage in follow-up group discussions. Complete surveys about their knowledge, treatment adherence, and health behaviors. Get weighed before and after dialysis sessions to monitor fluid retention. This study aims to improve how dialysis patients manage their condition and to help healthcare providers design better educational tools.

Theory of Kolcaba on the Quality of Life and Psychological Well-Being Levels of the Aged People

A randomised controlled study will be conducted to determine the effect of nursing care based on Kolcaba's comfort theory on the quality of life and psychological well-being levels of the elderly.

Effects of Wearable Devices Initiates Behavioral Change Intervention on Body Composition, Physical Activity, Sleep Quality and Stress of Nurses in Hospital Working Place

Background: Physically inactive and poor sleep quality are at increased risk for non-communicable diseases. Nurses were the most vulnerable inactive healthcare personnel who may not meet global physical activity recommendations because of complicated rotation shifts and heavy working loading. Wearable devices initiate behavior intervention combined with smartphone applications could offer new opportunities for social connection by a convenient way for nurses to improve physical activity and sleep quality. Objectives: To evaluate the effects of wearable devices initiate behavioral intervention on body composition, physical activity, sleep quality and stress of nurses in hospital working place. Method: This is a randomized controlled trial that will recruit 120 nurses and randomly assign them into two groups from a hospital working place. The nurses in the intervention group will receive 12-week wearable devices to initiate behavioral intervention. The nurses in the comparison group will only receive 12-week wearable devices monitoring. Data will be collected at baseline and 12-week and 24-week follow-up. The body composition will be measured by bioelectrical impedance analysis (BIA). The physical activity and sleep quality will be monitored by the Fitbit wearable device and application. The mediator parameter of the stress will be measured by salivary amylase activity (SAA). We will control the internal validity to assure the quality of training, treatment fidelity, identify barriers and facilitators of implementation, and assess participants' satisfaction. General estimating equations (GEE) will be applied to examine the effects of time and group interaction.

Reduction of Complications Associated With PICC Management

The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care frequency, due to the reduction of device manipulation. A high level of patient satisfaction is detected due to the controlled follow-up of the device care, as well as a decrease in the need for transfer to a center for follow-up. Objective: Identify the type of care frequency for PIVCs most beneficial for the reduction of complications associated with extraluminal device care (thrombosis, phlebitis, accidental removal, obstruction).

Novel Medical Device for Pharmacological Therapy

Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Objectives: To validate a newly created device for the reduction of complications related to the use of intravenous therapy Methods: A multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.

The Effect of a Peer Mentoring Program on Nursing Students

This project is designed as a quasi-experimental study to evaluate the effect of the Peer Leadership Program, established in the Nursing Department, on nursing peer mentor students' empathic self-efficacy, social self-efficacy, and youth leadership characteristics.

Using Cognitive-Behavioral Change and Mobile Technology to Improve RN Sleep and Fatigue

The U.S. registered nurse (RN) workforce is the largest in the Healthcare and Social Assistance Sector and is at high risk for injuries and errors due to poor sleep and fatigue. Shift work (i.e., nights, evenings, rotating shifts) can contribute to RNs not obtaining adequate, restful sleep. Work intensity, including heavy physical and emotional workloads of caring for critically ill patients, can contribute to job stress, resulting in spill-over effects at home when RNs experience difficulties falling and staying asleep. To address work and home sleep barriers, this project proposes the development and pilot testing of RN-SLEEP, a skill-building mobile application designed to improve sleep. RN-SLEEP will provide a convenient, flexible space to learn sleep-enhancing evidence-based shift work-specific strategies, and cognitive-behavioral methods, (e.g., goal setting, relaxation training). Using NIOSH's Research 2 Practice (R2P) approach, the study team will collaborate with participants (N=18-24) from an RN union to refine RN-SLEEP content, integrating current sleep literature (including National Institute for Occupational Safety and Health \[NIOSH\] material) with cognitive-behavioral based training. RN-SLEEP will be pilot-tested using a two-group pretest-posttest study design, comparing sleep outcome measures (duration, quality) of RN-SLEEP participant users (n=38) with participants from an education control group (n=38). Data trends on fatigue, what drives behavior change (beliefs and self-efficacy), and other sleep outcome measures (timing, regularity, efficiency, daytime sleepiness) will be explored. RN-SLEEP goals align with Healthy People 2030, NIOSH's strategic goal to promote safe and healthy work design and well-being through two NIOSH Healthcare and Social Assistance Sector/Healthy Work Design Cross-Sector (HCSA/HWD) intermediate goals. HWD goal 7.2A is to conduct intervention research addressing fatigue (poor sleep sequela) due to suboptimal work designs (shift work) in the healthcare industry. HCSA/HWD goal 7.12A prioritizes interventions designed to impact work and non-work contributors to safety and health. This RN-SLEEP intervention aims to improve sleep by building skills that help RNs overcome obstacles to sleep from work and home, thus improving health and safety. Immediate outputs include a mobile app, designed and tested in collaboration with RNs, to improve sleep. Study results will be disseminated through our union collaborators, nursing conferences and journal publications, and our University's NIOSH-sponsored Education and Research Center social media outlets. Intermediate outcomes include enhancing RN sleep through training rarely available in nursing schools and traditional hospital health and safety training programs. Improving sleep can reduce fatigue and may decrease occupational injuries and errors. RN-SLEEP is adaptable, where future versions could be modified to meet the needs of other HCSA workers (i.e., nursing aides) and workers in other industries (e.g., oil and gas) scheduled to work non-standard work hours. End outcomes include integrating RN-SLEEP into a broader hospital organization intervention to mitigate fatigue risks.

Evaluation of Nursing Students' Crisis Management Skills in Medication Safety Simulation

This study aims to objectively evaluate student nurses' crisis management skills in drug safety simulation and examine an effective intervention to improve these skills through a randomized controlled study. The research aims to provide important findings that will contribute to the determination of strategies to increase the competencies of student nurses in the fields of drug safety and crisis management. Research Hypotheses: H1: The application of drug safety simulation has an effect on the crisis management skill level of nursing students. The aim of the intervention is to develop a simulation program to enhance nursing students' crisis management skills in drug safety. This simulation program will provide students with the opportunity to recognize, assess, and effectively intervene in medication errors in real-world scenarios. The simulation program will include interactive case scenarios, virtual patients, and simulation sessions led by an instructor providing feedback to students. Additionally, learning materials covering topics such as prevention, recognition, and correction of medication errors will be provided