Clinical trials

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.

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.

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.

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.

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.

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.

This study aims to compare the effects of medium cut-off (MCO) and high-flux hemodialysis membranes on mineral and bone metabolism biomarkers in patients receiving maintenance hemodialysis. Chronic kidney disease-mineral and bone disorder (CKD-MBD) is characterized by disturbances in biomarkers such as fibroblast growth factor-23 (FGF-23) and sclerostin, which are associated with bone turnover, vascular calcification, and adverse clinical outcomes. This is a single-center, prospective, randomized, open-label, two-sequence, two-period crossover clinical study. Thirty adult patients receiving maintenance hemodialysis will be randomized to receive either MCO membrane treatment followed by high-flux membrane treatment or the reverse sequence, with each treatment period lasting three months. Serum FGF-23 and sclerostin levels will be measured at baseline, Month 3, and Month 6. Additional assessments will include pulse wave velocity (PWV), body composition monitoring (BCM), handgrip strength, health-related quality of life (KDQOL-36), pruritus severity (UP-Dial), and pain assessment (SF-MPQ). The study will evaluate whether MCO membranes provide additional benefits compared with conventional high-flux membranes regarding CKD-MBD-related biomarkers and patient-centered outcomes.

This observational study will compare cardiovascular status, bone mineral metabolism, systemic inflammation, body composition, functional status, quality of life, pruritus, and pain among patients receiving different renal replacement therapy modalities and healthy controls. Adult participants will be included in four groups: maintenance hemodialysis, continuous ambulatory peritoneal dialysis, automated peritoneal dialysis, and healthy controls. No new treatment, drug, dialysis modality, or experimental device will be assigned as part of the study. Participants will continue their routine clinical care. Serum interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), fibroblast growth factor-23 (FGF-23), and sclerostin levels will be measured. Arterial stiffness will be assessed using pulse wave velocity (PWV), and body composition will be assessed using the Body Composition Monitor (BCM). Handgrip strength, quality of life, pruritus, and pain scores will also be evaluated. The study will also explore correlations between biochemical biomarkers, arterial stiffness, body composition, and patient-reported outcomes. In the automated peritoneal dialysis group, objective treatment adherence will additionally be assessed using the Sharesource (Baxter/Vantive) cloud-based remote patient monitoring platform.

Patients receiving maintenance hemodialysis are at increased risk of cardiovascular disease, chronic inflammation, endothelial dysfunction, and impaired quality of life. Medium cut-Off (MCO) hemodialysis membranes have been developed to enhance the removal of middle-molecular-weight uremic toxins compared with conventional high-flux membranes, which may improve inflammatory status and cardiovascular health. The aim of this study is to compare the effects of MCO and high-flux hemodialysis membranes on inflammatory biomarkers and cardiovascular function in adult patients receiving maintenance hemodialysis. The primary outcomes are changes in serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) levels. Secondary outcomes include arterial stiffness assessed by pulse wave velocity (PWV), body composition assessed by Body Composition Monitor (BCM), handgrip strength, and patient-reported outcomes including quality of life, pruritus, and pain scores. This is a prospective, randomized, open-label, two-sequence, two-period crossover study conducted at Gazi University Faculty of Medicine. Thirty adult hemodialysis patients will be randomized to one of two treatment sequences. Participants in Sequence A will receive MCO dialysis membranes for the first 3 months followed by high-flux membranes for the next 3 months. Participants in Sequence B will receive high-flux membranes for the first 3 months followed by MCO membranes for the next 3 months. Blood samples and clinical assessments will be performed at baseline, month 3, and month 6. The study is expected to provide evidence regarding the effects of different dialysis membrane technologies on inflammation and cardiovascular health and may contribute to optimizing membrane selection in routine hemodialysis practice.

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.

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.

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).

Childhood is a critical period for the development of lifelong health behaviors, and early interventions play an essential role in promoting long-term health and preventing future health problems. This study is planned to evaluate the effect of health education on children's healthy lifestyle skills.

The aim of this study is to evaluate gait in individuals diagnosed with PD under tasks involving different cognitive domains, to compare the results with those of age and sex-matched healthy individuals, and to determine which cognitive function has the greatest impact on gait in PD.

This randomized, controlled, parallel-group, interventional study aims to evaluate the effects of Crossword-Based Learning for Parenteral Drug Administration on the knowledge level, self-efficacy perception, and learning motivation of Nursing Department students. It is considered original because it examines the effects of crossword-based learning on cognitive and psychosocial outcomes in parenteral drug administration, a skill with a high risk of error in the clinical field. The study will be conducted with 80 (40 Experimental, 40 Control) nursing students selected through a power analysis. Participants will be assigned to groups by random assignment, and the study will be conducted in accordance with the triple-blind principle (participant, data collector, statistician). The experimental group will receive Crossword Activities in four different phases (Initial, Theoretical, Laboratory, and Post-Clinical Practice) in addition to the standard educational content. The control group will only complete the standard education. The primary outcomes of the study are; At the end of the 4th stage, the Parenteral Drug Administration Knowledge Test will be evaluated based on the Safe Parenteral Drug Administration Self-Efficacy Scale (SES-SES) and the Higher Education Learning Motivation Scale (SLS-SES) scores.

This study aims to evaluate the effect of artificial intelligence (AI)-supported virtual reality (VR) simulation on nursing students' holistic care skills. The study is a randomised controlled trial involving fourth-year nursing students, divided into an experimental and a control group. Whilst the experimental group will receive AI-supported VR simulation training, the control group will receive traditional case-based training. Outcomes to be assessed include decision-making, symptom identification, nursing diagnosis, simulation design and satisfaction with the training methods.

his study aims to determine the effect of a gamification-based educational method on nursing students' learning of stoma care. The research will be conducted as a pretest-posttest, parallel-group randomized controlled experimental study. 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). Participants will consist of fourth-year nursing students who voluntarily agree to participate in the study. After obtaining informed consent, participants will complete a descriptive characteristics form and the Stoma Care Knowledge Test. Randomization will be performed based on baseline knowledge levels, and participants will be assigned to experimental and control groups. Students' knowledge levels will be assessed using the "Stoma Care Knowledge Test," and their skills will be evaluated using a "Skills Checklist." Following baseline knowledge and skill assessment, the experimental group will receive gamified stoma care education, while the control group will receive standard education. The gamification intervention is designed based on the Werbach D6 Model and aims to enhance students' knowledge and skills in stoma care. Post-intervention knowledge and skill assessments will be conducted one week after the training. In addition, follow-up measurements will be performed four weeks later to evaluate the retention of knowledge and skills.