Clinical Research Directory

Study of TRE Seals on Early Post-operative Subjects

This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.

Effect of Word Search and Case-Based Puzzle Use in Stoma Care Education of Nursing Students

Objective: This study aims to determine the effect of using word search and case-based puzzles in stoma care education on nursing students' knowledge levels. Given that traditional teaching methods may have limited effectiveness in helping students acquire knowledge and skills, the study aims to demonstrate the contribution of integrating active learning and gamification-based approaches into education. Design: The study is planned as a randomized controlled experimental design and will use a pre-test-post-test measurement approach. Method: The study will be conducted with second-year students from the Nursing Department at Gazi University. This research will be prepared under the guidance of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) protocol, and the reporting of the randomized controlled study will be carried out under the Consolidated Standards of Reporting Trials (CONSORT). In the study, students will be randomly assigned to the experimental and control groups. The experimental group will receive training that includes word search and case-based puzzles during the stoma care training process, while the control group will receive training using traditional teaching methods. Students' knowledge levels will be assessed with measurements applied before and after the training, and student opinions regarding the training method will also be analyzed. The "Stoma Care Knowledge Level Assessment Test" will be used to evaluate knowledge levels, and the "Student Opinions on the Use of Puzzles and Word Searches in Stoma Education" form will be used to determine student opinions. Hypothesis: The null hypothesis (H0) of the study states that the use of word search and case-based puzzles in stoma care education has no effect on students' knowledge level; the alternative hypothesis (H1) states that this educational method significantly affects students' knowledge level.

Observational Study of Ostomy Consumers

The purpose of this longitudinal prospective observational study is to collect electronic Patient Reported Outcome (ePRO) data over a 7-year period directly from people living with an ostomy and their caregivers (participants were re-consented with version 3 of the Protocol in 2020 which indicated a study duration of 5 years, and version 6 of the Protocol in 2025 extending for an additional 2 years). Research participants will be asked to self-report on the ostomy pouching systems they typically use and other various aspects of living with an ostomy and/or caring for an individual living with an ostomy.

MOBILE EDUCATION AND COMFORT IN OSTOMY PATIENTS

Purpose of the Study This study aims to understand whether a mobile education program can improve comfort levels in people living with a stoma. A stoma is a surgical opening created on the abdomen to allow stool or urine to leave the body. Living with a stoma can affect daily life in many ways, including physical comfort, emotional well-being, social life, and the home environment. The education program used in this study is based on Kolcaba's Comfort Theory. This theory focuses on comfort as a whole and includes physical, emotional, social, and environmental aspects of a person's life. The study will compare people who receive mobile education with those who receive standard hospital care only. Who Can Take Part Adults aged 18 years and older who are scheduled to have colostomy, ileostomy, or urostomy surgery may take part in this study. Participants must be able to communicate in Turkish, read and understand written information, and agree to join the study voluntarily. People with severe cognitive problems, serious communication difficulties, or major vision or hearing problems will not be included. What Will Happen in the Study Participants will be randomly assigned to one of two groups: Mobile Education Group Standard Care Group Both groups will receive routine care provided by the hospital. Participants in the mobile education group will also receive access to a mobile application designed specifically for people with a stoma. This application includes: Easy-to-understand information about stoma care Animated educational videos showing step-by-step stoma care practices Guidance on skin care, pouch changing, and hygiene Information on common problems and when to seek medical help Reminders to support daily stoma care routines The mobile application can be used on smartphones and does not include diagnosis or treatment. It is for education and support only. Participants in the standard care group will receive usual hospital education and care. After the study is completed, they will also be offered the mobile education program. What Participants Will Be Asked to Do All participants will be asked to answer questionnaires that measure comfort levels at several time points: Before surgery One day after surgery Fifteen days after discharge (by phone) One month after surgery (during a clinic visit) Participants in the mobile education group will be shown how to use the application and may use it as often as they wish. Researchers may contact participants to ask about their experience using the app and to identify any difficulties. Possible Benefits Participants may gain better understanding of stoma care and feel more confident managing daily life with a stoma. The mobile education program may help reduce discomfort, support emotional well-being, and improve overall quality of life. The results of this study may help healthcare professionals develop better education tools and support programs for people living with a stoma. Risks and Safety This study does not involve experimental medical treatments. The mobile application provides education only. Personal data will not be collected through the app, and all information will be kept confidential. Participants may leave the study at any time without affecting their medical care. Why This Study Is Important Access to stoma care education can be limited due to time constraints, staff availability, and hospital resources. Mobile education may provide an easy and accessible way for people to receive reliable information whenever they need it. This study will help determine whether a comfort-focused mobile education program can support people living with a stoma and improve their overall comfort and well-being.

Improving the Quality of Life and Self-sufficiency of Individuals With Stoma: Pecha Kucha Training Via Smartphone

This study was planned as a randomized controlled trial to determine the effect of stoma care training given by the Pecha Kucha method to improve the quality of life and self-sufficiency of individuals with stoma.

Novel Post-Surgical Incision Management to Prevent Ostomy Complications

The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet, as compared to standard of care ostomy pouches, in reducing complications for ostomy and fistula patients. Secondary objectives include evaluating dressing leak rates and causes of complications (e.g., edema, tissue oxygen saturation, and poor stoma eversion). The main questions it aims to answer are: Primary Hypothesis 1: Peristomal Skin Complications will decrease Primary Hypothesis 2: Dressing Leak Rates will decrease Participants will: * Receive either the Limpet device or standard of care adhesive ostomy pouch dressing * Return every 7 days for study visits for 30 days to receive device replacement, wound imaging, blood tests, and quality of life surveys.

Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

The purpose of this study is to evaluate the feasibility of using a realistic and anatomically accurate 3D printed simulation model for urologic bowel diversion patient education. Using a randomized two group design, we aim to determine whether the use of this model enhances patient knowledge, self-care skills, and confidence in ostomy care. We will also evaluate changes in quality of life (QOL) and patient satisfaction comparing patients exposed to the 3D model to those receiving standard of care. The secondary aim of the study is to examine the differences between groups on patient outcomes including hospital duration, mortality, emergency/urgent health care visits, readmissions, and infections. Participants will be educated using 3D model simulation as part of their preoperative education (experimental group) or have standard education without using the simulation model (comparator group). Both groups will complete quality of life (QOL), ostomy adjustment, and satisfaction with education surveys during their preoperative education visit and again during their routine follow-up visits (a) within 3 weeks after surgery, (b) between 5- 8 weeks after surgery, and (c) at approximately 3 months after surgery.

Ostomy Rural Telehealth Training Cancer Survivors

Over one million individuals in the U.S. have ostomies. The American Cancer Society estimates 43,030 rectal cancer cases and 81,190 bladder cancer cases will be diagnosed in 2018.Of these, at least 30,000 will receive ostomies, and an additional unknown number due to gynecologic, other gastrointestinal, or other gastro-urinary tumors. The health-related quality of life impact is tremendous and greater than with many other cancer treatments. An ostomy is often a prolonged or lifelong disabling problem for cancer survivors. The adaptation period is quite variable. In our R01 study, 18% of participants took at least one year to be comfortable, or never felt comfortable, in managing their ostomy care. Importantly, many patients cannot attend in-person self-management programs or patient groups for a myriad of reasons, including distance to travel, lack of access to transportation, monetary outlays, competing demands (such as work), or comorbidities making travel difficult. In addition, a national shortage of OCNs means patients with an ostomy, whether newly placed or a long-term issue, receive little help. It is imperative to study interventions for rural survivors aimed to limit family financial burdens, improve ostomy outcomes, and improve survivors' well-being.

High-fidelity Simulators and Standardized Patients on the Stoma Care

This is a randomized controlled study to investigate the effects of skill training on a low-fidelity simulator with a standardized patient using a wearable ostomy model on the stoma care skills and satisfaction levels of nursing students.

3D Printed Personalized Ostomy Appliance

The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is: • Whether or not a 3D scan of a stoma reduces leakages and improves patient quality of life in regard to using a personalized ostomy appliance. Participants will * Spend 2 weeks with their standard of care ostomy appliance * Spend 2 weeks with their personalized ostomy appliance made from a 3D scan * Participate in daily surveys and weekly quality of life surveys conducted over the phone