Clinical trials

This randomized controlled trial aims to compare the incidence of hemidiaphragmatic paralysis (HDP) following ultrasound-guided interscalene block (ISB) versus shoulder pericapsular nerve group (PENG) block in patients undergoing elective shoulder surgery under general anesthesia. The primary objective is to determine whether the shoulder PENG block reduces the incidence of HDP compared with conventional intrafascial ISB. HDP will be assessed using ultrasound measurement of diaphragmatic excursion 30 minutes after block performance

This study aims to investigate how food cravings change when visual food cues are enriched with sound, smell, and interactive experiences in a virtual reality (VR) environment. A total of 34 healthy Marmara University students aged 18 and older will participate in the study between November 2025 and March 2026, with a possible extension until September 2026. Participants will be exposed to real, virtual, and multisensory food cues, and their food craving levels, saliva composition, blood glucose, EEG activity, and body temperature will be measured. Salivary alpha-amylase will be analysed as a biomarker of physiological arousal during food cue exposure. The study aims to compare how virtual food cues affect food craving and physiological responses compared to real food cues. Findings are expected to contribute to understanding eating behaviour, developing VR-based interventions for healthy nutrition, and encouraging interdisciplinary collaboration between nutrition and engineering fields.

Parkinson's disease (PD) is a long-term condition that affects movement, balance, and thinking abilities. It can cause tremor, stiffness, slow movements, and difficulty maintaining balance. In addition to these physical problems, many people with PD also experience difficulties with memory, attention, and other cognitive functions. The balance system in the inner ear (vestibular system) helps maintain posture and orientation, but this system may not work properly in people with PD. This study aims to compare two different types of exercise programs to improve movement, balance, and cognitive abilities in individuals with PD. One program focuses on exercises that stimulate the balance system (vestibular rehabilitation), while the other combines thinking and movement activities at the same time (dual-task training). Thirty-six people with PD will take part in the study. Participants will be randomly assigned to one of three groups: vestibular exercise group, dual-task exercise group, or control group. Exercises will be done under the supervision of a physiotherapist twice a week for eight weeks. Each session will last about 40 minutes and include activities that are safe, structured, and personalized. Before and after the 8-week program, participants will complete simple tests that measure their memory, attention, walking ability, balance, and daily activity level. The results will show whether these exercise approaches can help improve both body and brain functions. The findings of this study are expected to help physiotherapists design more effective and personalized rehabilitation programs for people with Parkinson's disease, leading to better balance, safer movement, and improved quality of life.

Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G\*Power based on the pilot data. Data will be collected using the "Descriptive Information Form for Children with Diabetes" and the "Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms." The "Find-Solve-Learn Insulin Self-Management Activity Book" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.

This cross-sectional observational study aims to evaluate neuropathic pain severity in patients with lumbar spinal stenosis (LSS) and to investigate its association with radiological findings. Neuropathic pain will be evaluated using the Neuropathic Pain Symptom Inventory (NPSI). Pain intensity, neuropathic pain characteristics, functional status, walking capacity, and psychological symptoms will also be assessed. The relationships between NPSI scores and clinical, functional, psychological, and radiological parameters will be investigated.

This prospective observational study aims to investigate the association between sarcopenia and clinical outcomes following interlaminar epidural steroid injection in patients with lumbar spinal stenosis. Patients who are scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care will be enrolled. Before the procedure, sarcopenia-related assessments, including the SARC-F questionnaire, handgrip strength, and the five-times sit-to-stand test, will be performed. Lumbar magnetic resonance imaging (MRI) will also be evaluated for paraspinal muscle characteristics and the severity of lumbar spinal stenosis. Pain intensity, functional status, walking capacity, and health-related quality of life will be assessed at baseline. Pain intensity, functional status, and health-related quality of life will be reassessed at 3 weeks and 3 months after the procedure. The study will evaluate whether sarcopenia and MRI-based paraspinal muscle characteristics are associated with clinical outcomes following interlaminar epidural steroid injection.

This prospective observational study aims to investigate the association between subcutaneous fat index, paraspinal muscle characteristics, facet morphology, and lumbar facet joint degeneration in adults with chronic low back pain. The study will use lumbar magnetic resonance imaging (MRI) obtained as part of routine clinical care. The study will evaluate whether subcutaneous fat index is associated with moderate-to-severe lumbar facet joint degeneration and will also examine the relationships of disc degeneration, facet morphology, paraspinal muscle characteristics, and pain severity with facet joint degeneration.

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that can affect posture, trunk movement, and respiratory function. Changes in the shape of the rib cage may influence diaphragm function and breathing mechanics in individuals with scoliosis. The Schroth Best Practice (SBP) exercise program is commonly used in the conservative treatment of scoliosis and focuses on posture correction and scoliosis-specific exercises. However, the additional benefits of manual diaphragm mobilization combined with this exercise program are not well known. The aim of this randomized controlled trial is to investigate the effect of diaphragm mobilization added to the Schroth Best Practice program in adolescents with idiopathic scoliosis. Participants will be randomly assigned to two groups: one group will perform the SBP exercise program alone, and the other group will receive SBP exercises combined with diaphragm mobilization. The intervention will be performed three times per week for six weeks. Assessments will be conducted at baseline, at the end of the 6-week intervention, and at a 12-week follow-up. Outcomes will include respiratory function measured by spirometry, trunk rotation, thoracic mobility, trunk flexibility, quality of life, and body image. The results of this study may help determine whether adding diaphragm mobilization to scoliosis-specific exercise programs improves clinical outcomes in adolescents with idiopathic scoliosis.

This prospective observational study aims to evaluate changes in chewing patterns and chewing performance in children before and after placement of a unilateral fixed band-and-loop space maintainer. Children aged 6-10 years who require a space maintainer as part of routine clinical care will be evaluated before appliance placement and again four weeks after placement. Chewing pattern will be assessed by observing the preferred chewing side during standardized chewing trials, and chewing performance will be evaluated using a two-color chewing gum test scored with the Orophys Subjective Assessment Scale. No additional invasive procedure will be performed for research purposes; the space maintainer treatment will be provided as part of routine clinical care.

Chronic coccydynia is characterized by pain localized to the coccygeal region that typically worsens with sitting, leading to notable impairments in functional performance and health-related quality of life. In clinical practice, fluoroscopy-guided Ganglion Impar Block (GIB) is commonly performed as an interventional treatment in patients unresponsive to conservative medical therapies. Alexithymia, defined as a multidimensional personality construct involving difficulty identifying and describing feelings alongside an externally oriented thinking style, has been shown to be prevalent in chronic pain conditions and associated with pain intensity, mood symptoms, and functional disability. The primary objective of this prospective analytical cross-sectional study is to examine the relationship between alexithymia levels (evaluated via the 20-item Toronto Alexithymia Scale \[TAS-20\]) and pain intensity, health-related quality of life, anxiety, depression, and childhood trauma in patients with chronic coccydynia who are scheduled to undergo Ganglion Impar Block based on routine clinical indications.

Low back pain and lumbosakral radiculopathy represent common clinical challenges substantially diminishing health-related quality of life and work productivity. Transforaminal Epidural Steroid Injection (TFESI) is widely performed in routine practice to reduce radicular pain, enhance functional capacity, and mitigate the need for surgery. However, clinical response to TFESI remains notably heterogeneous, indicating that biomedical parameters alone may not fully account for treatment efficacy and that psychosocial variables play a critical role. Alexithymia, defined as difficulty in identifying and describing emotions coupled with an externally oriented cognitive style, is prevalent among individuals with chronic spinal pain and linked to heightened pain perception and affective distress. This prospective observational cohort study aims to investigate the influence of baseline alexithymia levels (measured by the 20-item Toronto Alexithymia Scale \[TAS-20\]) on treatment response (defined as pain relief and functional improvement) following routine clinically indicated TFESI in patients with chronic low back pain and radiculopathy.

This prospective observational study aims to evaluate the sensitivity of the femoral stretch test in patients with unilateral, single-root L2, L3, or L4 nerve root compression and to determine whether test positivity differs according to the affected nerve root. Patients with unilateral radicular symptoms and magnetic resonance imaging-confirmed single-root compression involving the L2, L3, or L4 nerve root who are scheduled to undergo transforaminal epidural steroid injection as part of routine clinical care will be included. The decision to perform transforaminal epidural steroid injection will be made independently of participation in the study. Before the procedure, the femoral stretch test, pain intensity, neuropathic pain characteristics, dermatomal concordance of symptoms, and relevant magnetic resonance imaging findings will be recorded. The femoral stretch test and pain intensity will be reassessed 1 hour after the procedure. The study will primarily evaluate the sensitivity of the femoral stretch test for L2, L3, and L4 nerve root involvement and will also assess changes in test findings following transforaminal epidural steroid injection.

The aim of this study is to evaluate the effect of a digitally based hand hygiene education program developed for primary school students on their proper handwashing skills. School-age children are a vulnerable group with regard to infectious diseases, and hygiene behaviors acquired during this period have long-term significance for both individual and public health. Research has shown that primary school students often lack sufficient knowledge and skills regarding personal hygiene and handwashing, highlighting the need for the planning and implementation of hygiene education programs for children. Although hand hygiene is one of the simplest and most effective methods for preventing the transmission of infections, children frequently do not perform it using the correct technique. The literature indicates that educational interventions significantly improve primary school students' knowledge and skills related to hand hygiene. However, studies examining the effectiveness of digitally designed educational interventions remain limited, which constitutes the primary motivation for this research. The visual, interactive, gamified, and repeatable features of digital content support students' active engagement in the learning process and enhance learning effectiveness. This study designs a digital-method-based educational intervention aimed at improving students' proper handwashing skills. Initially, the hand hygiene skills of students in both groups will be assessed using the Semmelweis Hand Hygiene Scanner, an objective measurement device that analyzes hand-rubbing techniques during handwashing and provides visual and percentage-based feedback. Subsequently, students' knowledge levels will be assessed through an interactive game. While offering an enjoyable experience for children, the game will simultaneously enable the evaluation of their hand hygiene knowledge. At this stage, no educational intervention will be provided to the control group, whereas students in the intervention group will watch an animated film designed to teach proper handwashing techniques. Following the implementation of the educational intervention exclusively in the intervention group, measurements will be repeated in both the intervention and control groups on Day 15, at Month 1, and at Month 3. The effects of the digital education program on hand hygiene knowledge and skill levels will then be compared between the groups over time. The originality of this study lies in its examination of the effects of digital hand hygiene education for primary school students through the use of an objective assessment tool. The study will provide scientific evidence regarding the effectiveness of digital educational methods utilized by school health nurses. From a cultural perspective, it is expected to contribute to the development of proper handwashing habits and the adoption of healthy lifestyle behaviors among children. From an economic perspective, it may indirectly contribute to reducing infection-related hospitalizations and healthcare costs. Furthermore, the animated film and interactive game used during the educational process are expected to increase students' learning motivation, encourage active participation, and provide sustainable learning opportunities. In this way, the study aims to make an original and comprehensive contribution to both the academic literature and school health practice.

Patients with lumbosacral radiculopathy frequently experience neuropathic pain due to nerve root compression. Transforaminal epidural steroid injection (TFESI) is commonly used for pain relief in these patients. This study aims to evaluate the effect of TFESI on neuropathic pain severity using the Neuropathic Pain Scale (NPS) in patients with lumbosacral radiculopathy. Clinical outcomes before and after the procedure will be compared.

Overactive bladder (OAB) is a common condition characterized by urinary urgency, usually accompanied by increased urinary frequency and nocturia, with or without urgency urinary incontinence. Several non-invasive treatment options are available, including pelvic floor exercises and neuromodulation. This prospective, randomized study aims to compare the effectiveness and safety of transcutaneous peroneal electrical neuromodulation and pelvic floor exercises in adults with idiopathic OAB. Participants will be randomly assigned in a 1:1 ratio to receive either transcutaneous peroneal neuromodulation or pelvic floor exercise therapy for 3 months. Treatment outcomes will be assessed using bladder diary parameters and OAB symptom scores at baseline and at 1 and 3 months after treatment initiation. Treatment adherence and treatment-related adverse events will also be evaluated. The study aims to determine whether transcutaneous peroneal neuromodulation provides comparable or improved clinical outcomes compared with pelvic floor exercises in patients with idiopathic OAB.

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity occurring in growing individuals. In cases with progressive curvature, posterior spinal fusion and instrumentation (PSF) is considered the gold-standard surgical treatment for correcting the deformity and stabilizing the spine. Although surgery provides correction of the deformity, the loss of motion in the fused spinal segments may alter trunk biomechanics, potentially affecting postural control, balance mechanisms, and plantar pressure distribution. Although several studies have investigated balance and postural control parameters in individuals with AIS, no study has been identified that objectively examines the effects of postoperative rehabilitation programs on stabilometric balance, postural control, and plantar pressure distribution following PSF surgery. This study aims to investigate the effects of an exercise-based rehabilitation program on stabilometric balance, postural control, and plantar pressure distribution in individuals with AIS who have undergone PSF surgery. This randomized controlled trial is planned to include at least 42 individuals with AIS who have undergone PSF surgery and are being followed by the Department of Neurosurgery at Marmara University. Participants will be randomly assigned to an intervention group or a control group. The intervention group will participate in an exercise-based rehabilitation program consisting of two sessions per week for eight weeks. Consistent with routine practice, the control group will not participate in a structured rehabilitation program. Postural control, stabilometric balance, and plantar pressure distribution will be assessed using a stabilometric and baropodometric platform system. Assessments will be conducted before and after the rehabilitation period. The findings are expected to contribute to the scientific evidence regarding postoperative rehabilitation approaches. The results may also guide clinicians in planning exercise-based rehabilitation programs following scoliosis surgery and provide patients and their families with useful information regarding the postoperative recovery process.

Psoriatic arthritis (PsA) is a chronic inflammatory disease that frequently involves the entheses, where tendons, ligaments, and fascia insert into bone. Early detection of enthesitis is important for disease assessment and management. Conventional musculoskeletal ultrasonography, including grayscale and Power Doppler ultrasonography, can identify structural and inflammatory changes, while shear wave elastography (SWE) provides quantitative information about tissue stiffness. This observational cross-sectional study aims to evaluate bilateral enthesis sites using grayscale ultrasonography, Power Doppler ultrasonography, and SWE in patients with PsA and age- and sex-matched healthy controls. The study will investigate the relationship between imaging findings and clinical disease characteristics, disease activity, functional status, and laboratory parameters. The findings may improve understanding of enthesis involvement in PsA and clarify the potential role of multimodal ultrasound assessment, including SWE, in disease evaluation.

This cross-sectional observational study aims to evaluate the relationship between boron levels and oxidative stress, antioxidant defense, and inflammatory markers in individuals with periodontitis. The study will include systemically healthy, non-smoking individuals divided into two groups: periodontally healthy controls and patients with Stage III-IV periodontitis. Boron levels and selected oxidative stress, antioxidant, and inflammatory biomarkers will be evaluated in saliva and gingival tissue samples. The findings will be compared between the groups to investigate the potential relationship between boron levels and periodontal inflammation and oxidative stress.

This study evaluates whether the outcome of root coverage surgery can be predicted from a preoperative intraoral photograph. Adults with Cairo RT1,RT2 or RT3 gingival recessions treated with a coronally advanced flap and a connective tissue graft are followed for six months. Standardised photographs and clinical measurements are obtained before surgery and at each follow-up visit. A deep learning model is developed to predict the surgical outcome from the preoperative photograph and baseline clinical variables, and its performance is compared with the outcome measured clinically at six months. The model does not influence treatment decisions.

The goal of this clinical trial is to evaluate whether hyaluronic acid (HA) improves periodontal healing in people with periodontal disease who smoke. Moreover, the effects of HA on biomolecules and bacteria levels will be assessed during the follow up period. The main questions it will answer are: Will periodontal sites treated with HA gel after non-surgical periodontal treatment (NSPT) lead to better outcomes in clinical parameters compared to the sites treated with NSPT only in smokers? Will adjunctive use of HA gel reduce oxidative stress markers and bacteria levels during follow-up? Researchers will compare periodontal sites receiving NSPT with adjunctive HA gel application to sites receiving NSPT alone to determine whether HA provides additional clinical, biochemical and microbiological benefits. Participants will: * first receive full-mouth NSPT then, randomization will be performed in selected jaw to determine the test sites. These two interproximal test sites will additionally receive HA gel application. * attend follow-up visits at 1, 3 and 6 months for clinical periodontal measurements and to provide gingival crevicular fluid samples (GCF) and subgingival samples. The GCF samples will be evaluated for Metallothionein (MT) and 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels and subgingival samples for periodontal pathogens.

The aim of this research is to evaluate the effect of animation-supported sleep safety training on the knowledge and attitudes of pediatric nurses. Sleep is one of the primary factors affecting an individual's cognitive development, learning capacity, and memory from the neonatal period through adulthood. Regulating the sleep environment plays a critical role in establishing sleep architecture; for efficient and safe sleep, the environment must be free from external stimuli such as temperature extremes and light . Ensuring standardization in infant sleep safety will both improve sleep quality and reduce the risk of sleep-related deaths, such as Sudden Infant Death Syndrome (SIDS). Since prone sleeping positions and bed-sharing are the primary factors increasing the risk of sleep-related deaths, the American Academy of Pediatrics (AAP) recommends creating a separate sleep area and supine positioning as safe sleep practices However, various studies have demonstrated that families' and pediatric nurses' knowledge levels regarding SIDS vary based on cultural practices, that common practices in sleep safety need to be disseminated, and that current training is insufficient . Nurses are the health professionals from whom families receive the most support during hospitalization and discharge processes. Technological advancements bring rapid changes in healthcare practices, necessitating the integration of technology into education to train qualified health professionals. Therefore, it is of great importance to train nurses with the most up-to-date and effective methods and to improve their knowledge and attitudes using digitally supported materials enriched with visual and auditory elements.

This study aims to evaluate the diagnostic accuracy of the straight leg raise test in patients with suspected lumbosacral radicular pain. Lumbosacral radicular pain is often caused by lumbar disc herniation and may radiate from the lower back or buttock to the leg. Although the straight leg raise test is commonly used in clinical practice, its diagnostic performance has been reported to vary. In this study, diagnostic transforaminal epidural steroid injection or selective nerve root block will be used as the reference standard. The sensitivity, specificity, likelihood ratios, and area under the curve of the straight leg raise test will be calculated. The findings may help guide clinicians in determining when the straight leg raise test is sufficient and when further diagnostic confirmation may be needed.

This study aims to investigate the prevalence and levels of alexithymia in patients diagnosed with chronic coccydynia (tailbone pain lasting for 3 months or longer) and to explore its relationship with various clinical and psychological parameters. Chronic coccydynia can significantly impair daily activities, functionality, and reduce quality of life. Participants in this prospective, observational study will be evaluated during their routine visits to the pain management clinic. Evaluation of the participants will be performed using validated self-report questionnaires, including the Toronto Alexithymia Scale (TAS-20) for alexithymia, the Hospital Anxiety and Depression Scale (HADS) for mood symptoms, the Childhood Trauma Questionnaire (CTQ-33) for early life adverse experiences, the Visual Analog Scale (VAS) for pain intensity, and the 12-Item Short Form Health Survey (SF-12) for quality of life. The primary objective of the study is to determine how alexithymia relates to pain severity, duration, emotional symptoms, childhood trauma history, and overall quality of life in this specific population. The results of this pilot study may help strengthen the biopsychosocial approach in the evaluation of chronic coccydynia and optimize future multidisciplinary treatment strategies.

The purpose of this study is to investigate the relationship between alexithymia levels and clinical parameters, including pain intensity and quality of life, in chronic pain patients treated with spinal cord stimulation (SCS). Chronic neuropathic pain can lead to psychological distress and decreased quality of life. While SCS is an effective neuromodulation therapy for managing refractory pain, patient outcomes vary significantly, suggesting that biomedically similar patients experience different levels of relief due to psychosocial factors. Alexithymia, characterized by difficulties in identifying and describing emotions, may significantly influence the individual pain experience and treatment outcomes. In this cross-sectional observational study, patients who underwent SCS implantation for clinical indications will be evaluated. Clinical data regarding pain history will be collected retrospectively from patient files, while psychosocial profiles will be assessed at a single time point using validated psychometric questionnaires. The study aims to contribute to a better understanding of psychosocial variables in neuromodulation outcomes, potentially aiding in improved patient selection and expectation management.

This study aims to evaluate and compare the effects of two different kangaroo care (KC) models on pain management in neonates undergoing phototherapy. Specifically, the research investigates the impact of mother-administered versus nurse-administered kangaroo care on pain levels during mandatory heel-stick blood sampling. The study seeks to determine which provider model is more effective in reducing procedural pain for these vulnerable newborns, thereby optimizing comfort and care protocols during phototherapy treatment.