Clinical trials

Falls are a major health concern among older adults and can lead to injuries, reduced independence, and a lower quality of life. In addition to physical changes associated with aging, an individual's confidence in preventing falls, maintaining balance, and managing situations during and after a fall may influence daily activities and social participation. The Multidimensional Falls Efficacy Scale (MdFES) is a questionnaire designed to assess older adults' confidence in performing everyday activities without falling. It includes activities related to both daily living and participation in the community. A culturally adapted and reliable Turkish version of this questionnaire is needed to assess fall-related self-efficacy in Turkish-speaking older adults. The aim of this study is to adapt the MdFES into Turkish and evaluate its validity, reliability, and other measurement properties in older adults. The study will examine whether the Turkish version measures fall-related self-efficacy appropriately and provides consistent results. The findings may provide researchers and healthcare professionals with a useful assessment tool for evaluating fall-related self-efficacy in older adults. This may support the identification of individuals who lack confidence in performing daily activities and contribute to research and clinical approaches aimed at improving confidence, independence, and participation in everyday life.

This clinical study aims to compare the effects of time-restricted eating and a personalized energy-restricted diet on anthropometric measurements, body composition, biochemical parameters, blood pressure, handgrip strength, menopausal symptoms, and sleep quality in obese postmenopausal women. The study is a 12-week, open-label, controlled, parallel-group clinical trial with a quasi-randomized allocation design. The coordinating center is the Department of Internal Medicine, Faculty of Medicine, Gazi University, and the study will be conducted at the Internal Medicine Outpatient Clinic of Cihanbeyli State Hospital in Konya, Türkiye. A total of 40 postmenopausal women are planned to participate, with 20 participants in each group. Participants will undergo an initial medical examination and baseline assessments, including demographic and health information, dietary habits, menopausal symptoms, sleep quality, physical activity, and dietary intake. Anthropometric measurements, body composition, handgrip strength, blood pressure, and biochemical parameters will also be assessed. Participants in the intervention group will follow a time-restricted eating schedule in which they will consume food within an 8-hour daily eating window and fast for 16 hours. The eating window will begin between 8:00 AM and 12:00 PM and will be determined by the participant. During the fasting period, water, unsweetened tea, plain coffee, and plain mineral water will be permitted. Participants in the control group will follow a personalized energy-restricted diet providing approximately 25% less energy than their estimated energy requirements. The diet will be planned according to menopausal nutrition recommendations and individual preferences. Dietary intake will be monitored every 2 weeks. Anthropometric measurements, blood pressure, and handgrip strength will be assessed every 4 weeks. All baseline assessments will be repeated after the 12-week intervention period. The study hypothesis is that time-restricted eating will result in greater improvements than the personalized energy-restricted diet in anthropometric measurements and body composition, biochemical parameters, blood pressure, handgrip strength, menopausal symptoms, and sleep quality in obese postmenopausal women.

This prospective longitudinal observational cohort study will characterize recovery of donor-ankle sensorimotor function in adults who have undergone primary anterior cruciate ligament reconstruction using a peroneus longus tendon autograft. Twenty participants aged 18 to 55 years will be evaluated at postoperative 6-8 weeks, 3 months, and 6 months. The donor limb and the contralateral non-donor limb will be compared using surface electromyography of the peroneus longus, force-platform measures of postural control, inertial-sensor gait analysis, active ankle joint-position sense testing, and clinical and patient-reported foot and ankle function measures. The study does not assign the surgical procedure or rehabilitation treatment.

Patients scheduled to undergo suturing for minor trauma in the emergency department frequently experience anticipatory pain and anxiety before the procedure. These experiences may negatively affect perceived pain, cooperation with treatment, adherence, satisfaction, and the overall care experience. However, the realities of emergency department practice, including crowding, high patient volume, staff shortages, and increased workload, may limit effective nurse-patient communication and comprehensive patient education. Patients awaiting suturing for minor trauma often experience uncertainty, prolonged waiting, fear of the procedure, and concern about pain. These factors may increase anxiety, which can further intensify pain perception and negatively influence patients' cooperation with treatment and satisfaction with care. Previous reports indicate that many patients waiting in emergency departments seek information about waiting times, care processes, and their medical conditions, highlighting a substantial need for accessible and reliable information. During this waiting period, patients may increasingly use artificial intelligence-based digital resources to obtain information about their health condition and the procedure they are about to undergo. However, information generated by artificial intelligence may be inaccurate, incomplete, or insufficiently tailored to the clinical context. Therefore, such information should be reviewed and validated by healthcare professionals before being provided to patients. This study aims to evaluate the effect of an artificial intelligence-assisted patient education material delivered during the pre-suturing waiting period on pain and anxiety levels among patients with minor trauma in the emergency department. It is also expected that the educational material developed within the scope of this study may contribute to patient education and supportive care in emergency department settings.

Pediatric patients, hospitalization in a pediatric intensive care unit (PICU) is not merely a situation requiring physical treatment, but also an experience that has significant psychosocial effects. This project was designed to evaluate the effect of a mood journal intervention on anxiety levels, mindfulness, and emotion regulation skills in conscious pediatric patients aged 9-14 years in a pediatric intensive care unit. An emotion journal is a supportive tool that allows children to express the experiences they have during the day, the emotions they feel, and their reactions to these emotions in a structured format. It is anticipated that this practice may help children develop their abilities to recognize, express, and regulate their emotions; it may also reduce their anxiety levels related to the intensive care process. Children admitted to the pediatric intensive care unit who are conscious, able to communicate, and meet the inclusion criteria will be assigned to the intervention and control groups using a randomization method. At the start of the study, both groups will be provided with the Child and Parent Information Form, the Child and Adolescent Mindfulness Scale, the Emotion Regulation Scale for Children and Adolescents, and the State Anxiety Scale for Children will be administered to both groups. The intervention group will participate in an emotion journaling program for 5 days, approximately 30 minutes per day, while the control group will receive routine clinical care. Data will be analyzed using the SPSS 30.0 statistical software; descriptive statistics, normality tests, parametric or non-parametric group comparison tests, and correlation analyses will be performed. As a result of the project, it is expected that the emotion journaling intervention will reduce children's anxiety levels, increase their mindfulness, and support their emotion regulation skills. It is anticipated that the findings will contribute to the development of implementable, low-cost, and child-centered psychosocial care interventions in pediatric intensive care units.

This randomized, double-blind, crossover clinical study aims to evaluate the acute effect of proso millet-based bread on postprandial glycemic response in adults with type 2 diabetes. A total of 52 participants are planned to be enrolled. Each participant will attend two test sessions and will consume proso millet-based bread in one session and white wheat bread in the other. The order of the test breads will be randomized, and the two sessions will be separated by a one-week washout period. Each bread portion will provide 50 g of available carbohydrate. During each test session, the bread will be consumed within 10 minutes with 250 mL of water. Capillary blood glucose concentrations will be measured at predefined time points from baseline to 180 minutes after the start of consumption. Postprandial glycemic response will primarily be evaluated using the incremental area under the glucose response curve (iAUC). The study will investigate whether the postprandial glycemic response following consumption of proso millet-based bread differs from that following consumption of white wheat bread in adults with type 2 diabetes.

hildren undergoing angiography frequently experience anxiety before the procedure, which may negatively affect physiological parameters and procedural cooperation. Although pharmacological approaches are commonly used to reduce anxiety, they may be associated with adverse effects and are not always necessary. Virtual reality (VR)-based guided breathing exercises offer a non-pharmacological approach that combines immersive distraction with breathing techniques to promote relaxation. This randomized controlled trial aims to evaluate the effect of a VR-based guided breathing exercise administered before angiography on anxiety and physiological parameters in children aged 9-18 years. A total of 60 participants will be randomly assigned to either a VR-based guided breathing exercise group or a standard care group. Anxiety and physiological parameters, including heart rate, blood pressure, respiratory rate, oxygen saturation, and body temperature, will be assessed before and after the intervention. The findings of this study may provide evidence for the use of VR-based guided breathing exercises as a safe and effective nursing intervention to reduce pre-procedural anxiety in pediatric patients.

This randomized controlled trial aims to evaluate the effects of drawing and writing activities on anxiety and positive and negative affect in adolescents with type 1 diabetes. A total of 50 adolescents aged 9 to 18 years will be randomly assigned to either the intervention or the control group. Participants in the intervention group will take part in a five-day online drawing and writing program, while the control group will receive standard care. Anxiety and positive and negative affect will be assessed before and after the intervention using validated questionnaires. The findings may provide evidence for the use of art-based interventions to support the psychological well-being of adolescents with type 1 diabetes.

Peri-implant diseases are inflammatory conditions affecting the gums and bone around dental implants. Peri-implant mucositis causes inflammation in the gums, while peri-implantitis can also lead to bone loss and, in severe cases, implant failure. Smoking is an important risk factor for these conditions because it may change how the immune system responds to inflammation and infection. This study will compare smokers and non-smokers with healthy dental implants, peri-implant mucositis, or peri-implantitis. Fluid samples will be collected from around the implants to measure proteins involved in inflammation, healing, and immune responses. The aim is to better understand how smoking affects the body's response to peri-implant diseases and to identify biological markers that may help assess disease risk and severity in the future.

Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.

Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive procedure frequently accompanied by preprocedural anxiety, which has been associated with altered physiological parameters, reduced procedural tolerance, higher sedation requirements and lower patient satisfaction. Nurses are in a position to deliver structured preprocedural information and thereby strengthen patients' sense of control. This randomized controlled trial will evaluate whether a structured, nurse-led, one-to-one educational intervention delivered before ERCP reduces state anxiety and improves procedure-related knowledge compared with routine institutional information. Sixty adult patients scheduled for ERCP will be randomly allocated to the intervention or control group. State anxiety will be assessed with the Spielberger State-Trait Anxiety Inventory (state subscale) and procedure-related knowledge with a 17-item multiple-choice questionnaire, both at baseline and immediately before the procedure.

The anterior cruciate ligament (ACL) is the primary structure responsible for controlling anterior-posterior translation and rotational stability of the knee joint. Although ACL reconstruction has long been considered the gold standard among surgical interventions following ACL injury, arthroscopic primary repair techniques have recently regained interest. With advances in minimally invasive surgical procedures, refined patient selection criteria, and improved rehabilitation strategies, the clinical effectiveness of primary repair is once again being re-evaluated. However, there remains a limited body of literature directly comparing the medium- to long-term effects of these two surgical techniques on neuromuscular performance, fatigue tolerance, and functional outcomes. The aim of this study is to comparatively investigate postoperative muscle strength and endurance, isokinetic fatigue response, muscle oxygenation, proprioception, knee stability, postural control, and patient-reported outcome measures in individuals who have undergone ACL reconstruction or primary repair. Assessments will include low- and high-velocity tests performed on the Cybex Norm isokinetic dynamometer, a 33-repetition fatigue protocol at 300°/s, muscle oxygenation analysis using Train.Red NIRS, knee laxity measurement via the GNRB arthrometer, single-leg balance and landing evaluations using the KFORCE force platform, and subjective outcome measures (IKDC, ACL-RSI). The findings of this study are expected to provide a more comprehensive understanding of how surgical technique influences physiological, biomechanical, and functional outcomes. This knowledge may contribute to the development of individualized rehabilitation approaches and evidence-based return-to-sport criteria.

This randomized controlled trial evaluates the acute effects of a single session of functional inspiratory muscle training on muscle oxygenation, exercise capacity, dynamic balance, and agility in elite male volleyball players aged 18 to 25 years. Thirty participants will be randomly assigned in a 1:1 ratio to an intervention group or a no-intervention control group. The intervention group will perform 60 resisted breaths at 50% of maximal inspiratory pressure using a POWERbreathe device during a sport-specific fixed-ball throwing drill. Both groups will complete assessments before and immediately after the intervention period on the same day. Quadriceps muscle oxygen saturation and total hemoglobin will be measured using a Moxy near-infrared spectroscopy monitor during the Incremental Shuttle Walk Test. Exercise capacity, dynamic balance, and agility will be assessed using the Incremental Shuttle Walk Test, Star Excursion Balance Test, and T-Test, respectively.

The aim of this study is to evaluate the effect of Montessori-based interventions on cognitive function and activities of daily living in older adults.

Nursing education aims to equip students with the knowledge, skills, attitudes, and behaviors required for safe and effective professional practice. However, traditional teacher-centered approaches are often insufficient for developing competencies such as critical thinking, problem-solving, decision-making, communication, and teamwork.Consequently, innovative student-centered teaching strategies are increasingly being integrated into nursing education.Game-based learning is one such strategy that enhances engagement, motivation, active participation, and collaborative learning. Among GBL approaches, the educational escape room combines gamification with problem-solving by requiring students to work collaboratively under time constraints to solve realistic clinical scenarios. This method promotes active learning while strengthening communication, teamwork, leadership, and clinical reasoning skills. Educational escape rooms have been successfully implemented in several areas of nursing education, including women's health, pediatric care, geriatric nursing, cardiovascular diseases, clinical skills, teamwork, and leadership. Despite these developments, evidence regarding their use in pediatric nursing education remains limited.Dehydration is one of the most common pediatric health problems and requires nurses to accurately assess hydration status, recognize clinical findings, and implement appropriate nursing interventions. Competence in dehydration management is therefore essential for pediatric nursing students. To date, no published study has evaluated an educational escape room designed specifically to teach pediatric dehydration management. This study aims to examine the effectiveness of an educational escape room implemented during a pediatric nursing laboratory simulation on nursing students' hydration knowledge, teamwork, and anxiety levels. It is expected that this innovative educational approach will enhance students' knowledge acquisition and teamwork skills while reducing anxiety during learning.

Heart valve diseases are the most common cause of mortality and morbidity after coronary artery disease, hypertension, and heart failure. In patients with mitral stenosis, the narrowed valve restricts blood flow, causing symptoms such as shortness of breath, fatigue, exertional dyspnea, orthopnea, and paroxysmal nocturnal dyspnea. These patients may experience decreased exercise capacity and physical activity levels, deterioration in quality of life, and deterioration in respiratory function. When reviewing the literature, we see that the study groups evaluating these factors are generally not homogeneous, and most studies conducted in patients with mitral stenosis evaluate patients who have undergone percutaneous mitral balloon valvuloplasty.

This study investigates whether tightness of a small chest muscle called the pectoralis minor is associated with the development of partial rotator cuff tears in the shoulder. Using a propensity score matched case-control design, the study compares patients with rotator cuff tears (case group, n=45) to patients with intact rotator cuffs (control group, n=45). Adults aged 18-55 who are evaluated by MRI and/or shoulder arthroscopy at Gazi University Hospital may be invited. The case group includes patients found to have partial rotator cuff tears during arthroscopy. The control group includes patients whose rotator cuff was documented as intact by MRI. Groups are matched 1:1 on age, sex, BMI, and dominant side. Before surgery, two trained clinician measures shoulder posture and pectoralis minor length using simple external tools (a digital caliper and ruler-like square). For arthroscopy patients, the surgeon records general arthroscopic findings. No extra procedures are added for research. We expect to include 90 participants total. The primary hypothesis is that pectoralis minor tightness is more prevalent in patients with rotator cuff tears compared to controls. A secondary hypothesis is that tears in patients with pectoralis minor tightness more often partial-thickness bursal side rotator cuff tear. Results may help clinicians understand shoulder mechanics and improve prevention or rehabilitation strategies.

Ultrasonographic evaluation of the inferior vena cava (IVC) is widely used in emergency and critical care settings for noninvasive assessment of intravascular volume status. The subcostal (SC) window is the standard approach; however, it is frequently limited by obesity, bowel distension, or postoperative anatomical changes. In such cases, the right coronal (RC) and anterior transhepatic (aTH) windows have been proposed as alternatives.

Benign perianal diseases such as chronic anal fissure, hemorrhoidal disease, and cryptoglandular anal fistula may negatively affect female sexual function through pain, bleeding, discharge, discomfort, and impairment in quality of life. Although improvement in male sexual function after surgery for benign anorectal disorders has been reported, data regarding female sexual function remain limited. This prospective observational cohort study aims to evaluate changes in Female Sexual Function Index (FSFI) scores following surgical treatment of benign perianal diseases. Female patients undergoing surgery for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula will be assessed preoperatively and at postoperative 3 and 6 months using the FSFI, Cleveland Clinic Incontinence Score (CCIS/Wexner), and Visual Analog Scale (VAS). The primary objective is to determine whether female sexual function improves following surgical treatment. Secondary objectives include evaluating the relationship between symptom improvement, continence status, pain reduction, and changes in female sexual function.

Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants will undergo baseline and 3-month anorectal symptom assessment and proctologic examination to evaluate newly developed proctologic diseases and changes in pre-existing symptoms.

To our knowledge, no studies have been conducted in the literature investigating the relationship between the success of physical therapy programs applied in knee osteoarthritis and patients' pre-treatment expectations. The rationale for this study is to demonstrate the possible relationship between treatment expectations and the benefits seen from conventional physical therapy programs in patients with knee osteoarthritis, and to provide clinicians with a different perspective in knee osteoarthritis treatment planning.

Patients with metastatic non-small cell lung cancer (NSCLC) and programmed death-ligand 1 (PD-L1) expression below 50% are commonly treated with different chemo-immunotherapy regimens in routine clinical practice. Although these regimens are widely used, comparative real-world data on survival outcomes and patient-reported quality of life are limited. This prospective observational study aims to compare two commonly used treatment approaches in patients with metastatic NSCLC and PD-L1 expression \<50%: chemotherapy plus pembrolizumab versus nivolumab plus ipilimumab combined with chemotherapy. Patients will receive treatment according to routine clinical decisions made by their treating physicians; no treatment assignment or intervention will be performed as part of the study. The primary outcomes of the study are progression-free survival and overall survival. In addition, health-related quality of life will be assessed using validated patient-reported outcome questionnaires during routine follow-up. Exploratory analyses will examine treatment outcomes in relation to selected clinical and patient-related factors, such as biological age, antibiotic exposure, and dietary patterns, in subsets of patients with available data. The results of this study are expected to provide real-world evidence on survival and quality of life outcomes associated with commonly used chemo-immunotherapy strategies in metastatic NSCLC.

This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months. Thirty high-risk infants admitted to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences will be randomly assigned to either the SAFE early intervention group or the Neurodevelopmental Treatment (NDT) group. Infants in the intervention group will receive the SAFE early intervention program for 8 weeks under the supervision of an experienced pediatric physiotherapist. The SAFE approach includes age-appropriate activities focusing on environmental enrichment, promotion of voluntary and goal-directed movements, sensory stimulation, fine motor skill development, postural control, transitional movements, and enhancement of infant-parent interaction through daily routines and home-based activities. Infants in the control group will receive conventional Neurodevelopmental Treatment (NDT) for 8 weeks. The NDT program includes age-specific activities targeting postural control, muscle tone regulation, facilitation of motor development, hand function, balance, weight transfer, and fine motor skills. Families will receive education regarding home-based activities and facilitation techniques specific to their infant's developmental needs. Follow-up will include home visits and weekly telephone monitoring to ensure adherence to the intervention program. Assessments will be performed before the intervention and after the 8-week intervention period by a physiotherapist blinded to group allocation.

This randomized controlled trial aims to evaluate the effectiveness of the mind mapping method in enhancing critical thinking and problem-solving skills among nursing students. The study will be conducted with 65 nursing students enrolled in a "Critical Thinking in Nursing" course at Gazi University during the 2025-2026 academic year. Participants will be assigned to experimental and control groups using stratified randomization based on pre-test scores from the "Marmara Critical Thinking Tendencies Scale" and the "Problem-Solving Inventory." The five-week intervention focuses on five clinical case studies: infection control, medication administration, patient safety, ethical issues, and systematic approaches. While both groups receive the same theoretical content, they follow different practical methodologies: The Control Group will engage in standard case analysis methods. The Experimental Group will work in small teams (4-5 students) to create and present visual mind maps for each case study, using either traditional or digital tools. Following the intervention, both groups will complete post-tests to assess changes in their critical thinking and problem-solving competencies.

This study will be conducted in a randomized controlled experimental design to examine The effect of art-based intervention on fatigue, anxiety, perception of nurse presence, and quality of life in patients with hematological cancer. The study will be conducted with 52 patients (26 intervention, 26 control groups) treated in the Hematology department of a training and research hospital between May 2025 and October 2026. Art-based intervention will be applied to the intervention group for 2 week (3 sessions per week), No application will be made to the control group. The data collection tools in the study are the Patient Identifier Information Form, Cancer Fatigue Scale, Functional Assessment of Cancer Therapy-General Scale (FACT-G), Hospital Anxiety and Depression Scale (HADS), and Nurse Presence Scale (PONS).