Clinical trials

Mechanical insufflation-exsufflation (MI-E) is an established airway clearance technique for patients with chronic conditions like neuromuscular diseases. However, its use in critically ill ICU patients remains inconsistent and lacks standardized guidelines. Despite growing research, current practices vary widely in patient selection, treatment protocols, and safety management, with limited high-quality evidence to support clear recommendations. To address this gap, an international, multidisciplinary Delphi consensus study is needed to establish expert-based best practices and feasible guidelines for the safe and effective implementation of MI-E in the intensive care setting.

In the context of this randomized controlled study, patients who are diagnosed with Rheumatoid arthritis in Cerrahpaşa Faculty of Medicine Hospital, will be taken into a rehabilitation program by a qualified physiotherapist to improve their pain, pain perception, inflammatory markers and quality of life, with one of the pain neuroscience education, vagal nerve stimulation and traditional exercise interventions. The results of each intervention method will be analyzed and compared at the end of the 8 weeks study protocol.

Pain after laparoscopic cholecystectomy remains clinically relevant, and current recommendations favour multimodal, opioid-sparing analgesia including regional techniques. The rectus intercostal fascial plane block (RIFPB) is a recently described technique in which local anesthetic is injected into the plane between the rectus abdominis muscle and the 6th and 7th costal cartilages, targeting the anterior and lateral cutaneous branches of the sixth to ninth thoracic (T6-T9) thoracoabdominal nerves. In the investigators' previous randomized controlled trial, bilateral RIFPB after laparoscopic cholecystectomy significantly reduced the need for rescue analgesia (17.9% versus 55.3%) and pain scores during the first 12 postoperative hours. That trial used 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total), a dose approaching the recommended upper limit, and whether lower doses provide comparable analgesia remains unknown. Because fascial plane blocks depend on local anesthetic spread, large volumes are preferred, increasing the total dose and the risk of local anesthetic systemic toxicity (LAST); lowering the concentration as volume increases has therefore been recommended. Equal-volume studies of transversus abdominis plane and erector spinae plane blocks suggest that lower concentrations provide comparable analgesia, but no study has compared concentrations for RIFPB. This trial will compare, at a fixed volume of 30 mL per side (60 mL in total), bilateral RIFPB with 0.25% bupivacaine, bilateral RIFPB with 0.125% bupivacaine, and routine port-site infiltration without a block (control) in adults undergoing elective laparoscopic cholecystectomy under general anesthesia. Ninety patients will be randomly allocated in a 1:1:1 ratio. The primary outcome is total rescue tramadol consumption during the first 24 postoperative hours. Secondary outcomes include numeric rating scale (NRS) pain scores at rest and on movement, the need for and time to first rescue analgesia, nausea, vomiting and pruritus, block-related complications and signs of LAST, patient satisfaction, and length of hospital stay. The investigators hypothesize that RIFPB at either concentration will reduce analgesic consumption and pain scores compared with control, and that the lower concentration will provide comparable analgesia while halving the total bupivacaine dose (75 mg instead of 150 mg), thereby reducing the risk of LAST.

This randomized controlled clinical study will evaluate the effects of intracanal cryotherapy during root canal treatment in patients with asymptomatic apical periodontitis. The study will investigate whether the temperature of the final irrigation solution influences the biological inflammatory response and postoperative pain. Participants will be randomly assigned to one of three groups according to the temperature of distilled water used for final root canal irrigation: 2-4°C, 8-10°C, or 22-24°C. Periapical tissue fluid samples will be collected before and after the intervention and analyzed for inflammatory and tissue-response biomarkers, including IL-1β, TNF-α, RANKL/OPG, PGE2, TGF-β, and MMP-9. Postoperative pain and analgesic use will also be recorded during the first 7 days after treatment. The study aims to determine whether intracanal cryotherapy can reduce the inflammatory response and postoperative pain associated with root canal treatment and whether these effects vary according to the temperature of the irrigation solution.

Obstructive Sleep Apnea Syndrome (OSAS) is commonly treated with CPAP devices, but adherence rates are low. Exercise has been shown to strengthen respiratory muscles, improve upper airway function, and enhance sleep quality. However, most studies have examined only single or dual exercise protocols, and there is little evidence regarding integrated programs with four exercise types or their effects when performed directly before sleep. This project aims to develop and evaluate ApneaTheraPlay (ATP), a digital gamified video-based exercise platform combining respiratory, aerobic, strengthening, and oropharyngeal exercises. The randomized controlled, double-blind study will allocate participants into three groups: ATP, a structured pre-sleep exercise group (SPEG), and a control group (CG). Intervention groups will exercise three times per week for 12 weeks, while the control group will only keep a physical activity diary.

The goal of this clinical trial is to evaluate the effect of a mobile game-based cognitive intervention on brain fog and psychological well-being in menopausal women aged 45-55 years. The main questions it aims to answer are: Are Brain Fog Scale scores lower among women in the mobile game intervention group compared with women in the control group? Are Warwick-Edinburgh Mental Well-Being Scale scores higher among women in the mobile game intervention group compared with women in the control group? Do women participating in the mobile game intervention demonstrate greater reductions in Brain Fog Scale scores and greater improvements in Warwick-Edinburgh Mental Well-Being Scale scores after the intervention compared with their baseline measurements? Researchers will compare participants receiving the mobile game-based cognitive intervention with participants receiving routine follow-up only to determine the effectiveness of the intervention on brain fog and psychological well-being. Participants will: Complete baseline assessments using the Brain Fog Scale and the Warwick-Edinburgh Mental Well-Being Scale. Be randomly assigned to either the intervention group or the control group. Use the cognitive training mobile game for 15 minutes per day, 5 days per week, for 6 weeks if assigned to the intervention group. Receive routine follow-up only if assigned to the control group. Complete post-intervention assessments at the end of the 6-week study period.

The HERMES Phase III study is an international, multicenter, prospective observational investigation designed to characterize the quality and safety of patient transport during advanced respiratory support. The study will enroll patients undergoing prehospital, interhospital, or intrahospital transport while receiving advanced respiratory support, including high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or invasive mechanical ventilation, as determined by routine clinical practice. The study protocol will not assign respiratory-support modalities, transport strategies, or therapeutic interventions. The primary objective is to prospectively evaluate clinical, technical, organizational, and transport-related factors associated with the safe continuation of respiratory support throughout patient transport. Data collection will include patient characteristics, respiratory-support modality and settings, transport characteristics, physiologic monitoring, transport-team composition, oxygen and electrical power resources, equipment-related events, interruptions or modifications of respiratory support, clinical deterioration, rescue interventions, escalation of respiratory support, and other transport-associated adverse events. HERMES Phase III constitutes the prospective multicenter component of a broader research program that previously included an international survey of respiratory-support transport practices and an exploratory prospective feasibility evaluation of portable external power during ambulance transport.

This randomized, sham-controlled clinical trial aims to evaluate the effect of acupressure on postoperative pain following laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. A total of 90 participants will be randomly assigned to one of three groups: standard postoperative care alone (control group), true acupressure plus standard care, or sham acupressure plus standard care. Acupressure will be applied at postoperative hours 1, 4, and 8 using the bilateral P6 (Neiguan), LI4 (Hegu), ST36 (Zusanli), and SP6 (Sanyinjiao) acupoints. The sham group will receive pressure at non-acupuncture points. The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes include analgesic consumption, postoperative nausea and vomiting, time to mobilization, patient satisfaction, and postoperative complications.

This randomized, double-blind, placebo-controlled clinical trial investigates the effects of oral Royal Jelly supplementation on sperm DNA fragmentation and pregnancy rates in couples with unexplained infertility. While routine semen analysis appears normal (normozoospermia) in these patients, underlying Sperm DNA Fragmentation (SDF) and oxidative stress are believed to contribute to reproductive failure. Participants will be randomized to receive either 750 mg of lyophilized Royal Jelly or a placebo daily for a period of 3 months (90 days). The study aims to evaluate whether the antioxidant properties of Royal Jelly can improve sperm chromatin integrity, reduce oxidative stress markers, and increase spontaneous pregnancy rates compared to the control group

This randomized, prospective study aims to compare the clinical efficacy of ultrasound-guided Deep Subgluteal Block (DSGB) versus Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve (LFCN) block for postoperative analgesia management in patients undergoing hip arthroplasty. A total of 60 patients scheduled for hip arthroplasty under general anesthesia will be randomly allocated into two equal groups of 30: Group DSG and Group PENG+LFCN. Total local anesthetic volume (30 mL) and active drug dose (75 mg bupivacaine) will be standardized across both groups to ensure rigorous blinding and high methodological quality. The primary outcome of the study is to compare total postoperative opioid (fentanyl) consumption within the first 24 hours. Secondary outcomes include postoperative pain scores evaluated via the Numerical Rating Scale (NRS) at rest and during movement, the presence and degree of quadriceps motor block, and opioid-related adverse effects (e.g., nausea, vomiting, pruritus).

This randomized controlled trial investigates the acute effects of three electrotherapy modalities (therapeutic ultrasound, interferential current, and TENS) on the mechanical and viscoelastic properties of neck muscles in young adults with forward head posture. Seventy-five participants will be randomly allocated to one of three groups. Muscle stiffness, oscillation frequency, and craniovertebral angle will be assessed before and immediately after a single treatment session.

This randomized controlled study will examine the acute effects of a medial arch support and a prefabricated insole on lower-limb muscle mechanical properties and pain in young adults with pes planus. Ninety participants will be allocated in a 1:1:1 ratio to a medial arch support group, an insole group, or a control group. Muscle mechanical and viscoelastic properties will be assessed with MyotonPRO, and pain will be assessed with a visual analog scale.

In the treatment of spondylolisthesis, conservative methods are initially preferred unless severe neurological symptoms are present; surgical treatment is only performed in refractory cases lasting at least 3-6 months. Conservative treatment consists of orthotic use, activity restriction, pain control, physiotherapy and exercise. Orthotics may promote healing by restricting movement; however, there are not enough studies on this subject. Exercise is the intervention with the highest level of evidence in chronic low back pain. The efficacy of stabilisation exercises in providing positive and long-lasting effects on pain and functional disability in patients with spondylolisthesis has been demonstrated. However, studies evaluating the effect of exercise on spinal stability and radiological findings are limited. Therefore, this study aims to compare the effects of stabilization and conventional exercises with orthosis on radiographic findings, pain, physical function and quality of life.

This study aims to evaluate the efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block for postoperative analgesia management in patients undergoing pilonidal sinus surgery under general anesthesia

This prospective, open-label clinical trial aims to compare a novel "Venous Tourniquet with Regional Low-Dose Sugammadex" method against the gold standard "Arterial Tourniquet" (Isolated Forearm Technique - IFT) for monitoring motor seizure activity during Electroconvulsive Therapy (ECT). Using a within-subject (intra-individual) design, each of the 40 enrolled patients will receive an arterial tourniquet on one arm and a venous tourniquet on the other arm simultaneously. The study will evaluate clinical efficacy in observing motor seizures, comparing the duration and visibility between the two limbs of the same patient, as well as assessing overall patient comfort and hemodynamics.

Lumbar microdiscectomy is a commonly used surgical procedure for treating herniated discs. Effective postoperative analgesia is crucial for early mobilization and functional recovery. Uncontrolled postoperative pain can delay recovery, increase the risk of opioid dependence, and lead to respiratory complications. Although opioid analgesics effectively reduce pain, they can cause side effects such as nausea, vomiting, respiratory depression, and dependency. Therefore, non-opioid analgesic methods are preferred for patient safety and comfort. Recently, regional anesthesia techniques such as the Thoracolumbar Interfascial Plane (TLIP) block and the Quadro Iliac Plane Block have been introduced for postoperative pain management in lumbar surgeries. However, there are not enough studies comparing the superiority of these two methods. Study Objective: The primary aim of this study is to evaluate the effects of ultrasound-guided TLIP and Quadro Iliac Plane Blocks on postoperative opioid consumption after lumbar microsurgery. The secondary aim is to compare opioid-related side effects (such as nausea, vomiting, respiratory depression, etc.) and postoperative NRS pain scores between the groups.

Aortic Stenosis (AS) is the most common valvular pathology, particularly prevalent in advanced age, and Transcatheter Aortic Valve Implantation (TAVI) has become a crucial treatment option for high-risk patients who are not suitable for surgery. This minimally invasive approach has demonstrated successful clinical outcomes in patients deemed ineligible for surgical procedures. Patient selection criteria and advancements in operative techniques are critical for achieving successful TAVI outcomes. While the transfemoral approach is the most commonly used method, alternative techniques such as transapical, transaxillary, transcarotid, and transaortic approaches are also available. The Pericapsular Nerve Group Block (PENG) targets the femoral and accessory obturator nerves, providing analgesia to the anterior hip without causing motor block. The Fascia Iliaca Block (FIB), on the other hand, provides broader analgesic coverage by affecting the lateral femoral cutaneous, obturator, and femoral nerves. This study aims to compare PENG block, FIB, and local infiltration anesthesia in TAVI patients regarding sedation requirements during the procedure and postoperative analgesia management. Additionally, pain scores, motor block presence, opioid consumption, and side effects will be assessed. The study seeks to identify optimal strategies to enhance patient comfort and safety during TAVI procedures.

This randomized controlled trial will evaluate the effects of a structured, task-focused occupational therapy program delivered in the school environment on handwriting performance, fine motor skills, visual-motor integration, and academic performance in primary school children. Second- and third-grade students identified as being at risk for handwriting and manual dexterity difficulties will be randomly assigned to an intervention group or a control group. The intervention group will receive a 10-week school-based occupational therapy program consisting of two 30-minute sessions per week, for a total of 20 sessions. The control group will continue routine classroom activities without therapist-led occupational therapy. Handwriting, manual dexterity, visual-motor integration, visual perception, and motor coordination will be assessed at baseline and after the intervention. Academic grades will also be recorded, and individualized goal attainment will be evaluated in the intervention group.

Breast milk is of great importance for preterm infants in terms of optimal growth, immune system development, and neurodevelopment. However, mothers who give birth prematurely may face various challenges during the breastfeeding process due to their infants' need for monitoring in the neonatal intensive care unit, mother-infant separation, and the need to pump breast milk. This situation can negatively affect the experience of expressing breast milk and the mother's perception of her competence in caring for her baby. The aim of this randomized controlled trial is to evaluate the effect of web-based breastfeeding counseling on the breast milk expression experience and the competence in caring for a preterm infant among mothers of preterm infants. A total of 56 mothers who gave birth preterm at 30 weeks of gestation or later and whose infants are being monitored in the neonatal intensive care unit will be included in the study. Participants will be randomly assigned to the intervention and control groups. Mothers in the intervention group will have access to a Moodle-based training program that includes video training on breastfeeding counseling and care for premature infants, as well as the opportunity to ask the researcher questions online. Mothers in the control group, on the other hand, will continue to receive the hospital's routine education and care services. The primary outcome measures of the study will be assessed using the Breastfeeding Experience Scale and the Premature Infant Care Competence Assessment Tool. Measurements will be taken at the start of the study, following the training, and at the end of the one-month follow-up period to examine the effect of web-based counseling on mothers' breastfeeding experience and care competence.

This prospective, randomized, controlled trial aims to evaluate and compare the therapeutic efficacy of intracavernosal urine-derived exosomes and systemic rectal ozone therapy in patients experiencing erectile dysfunction (ED) post-robotic-assisted radical prostatectomy (RARP). Patients will be randomized into two distinct intervention arms. The primary objective is to assess the functional recovery of the erectile tissue via the International Index of Erectile Function (IIEF-5) over a 6-month follow-up period. Secondary endpoints include penile hemodynamic alterations and overall health-related quality of life.

This prospective observational study aims to evaluate early subclinical acute kidney injury associated with pneumoperitoneum and Trendelenburg positioning during gynecological laparoscopic surgery. Urinary neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) levels will be measured and normalized to urinary creatinine. Biomarker changes will be compared between patients undergoing surgery in 30° and 45° Trendelenburg positions. The study seeks to determine whether these biomarkers can detect early renal injury before clinically significant changes in serum creatinine occur.

Parkinson's disease is a progressive neurological disorder associated with severe dopaminergic neuron loss in the substantia nigra pars compacta. The decrease in dopamine cells in the gut in Parkinson's disease negatively affects bowel movements, and constipation is a common condition. Impairment of the intestinal barrier increases inflammation. Reactive oxygen species increase, and intestinal homeostasis changes. Alpha-synuclein levels increase in the gut. L-theanine is the most abundant amino acid in green tea leaves. Parkinson's patients exhibit increased oxidative stress along with decreased activity of glutathione peroxidase, superoxide dismutase, and catalase. L-theanine is believed to increase the activity of these enzymes and reduce oxidative stress. L-theanine administration has been found to increase total short-chain fatty acids in stool. Furthermore, it is suggested that L-theanine inhibits imbalances in oxidative stress and inflammatory responses by reducing inflammatory factors such as TNF-α, IL-6, and IL-1β. REM sleep disturbance is also a common problem in Parkinson's disease. Studies have shown that following L-theanine treatment, participants' Pittsburgh Sleep Quality Index (PSQI) scale scores improved. The gut microbiota regulates sleep and neurological states via the microbiota-gut-brain axis. L-theanine supplementation appears to be able to regulate gut bacterial composition to suppress neurotransmitters, cytokines, and other metabolites to regulate sleep. The protective effects of L-theanine administration on increased dopamine and other neurotransmitters, microbiota, sleep, and antioxidant enzymes may offer a glimmer of hope regarding its beneficial role in Parkinson's disease.

This study aims to compare the effects of time-restricted eating (TRE, 16/8) in adults with obesity who have and have not undergone bariatric surgery (BS). The study will include adults aged 18-65 years: those with obesity who have not undergone BS, and those who have experienced insufficient weight loss (IWL) or weight regain (WR) following BS. Both groups will follow a 16:8 time-restricted eating protocol for 6 weeks, with an 8-hour eating window recommended between 10:00 AM and 6:00 PM, though participants may adjust to other 16-hour fasting windows. Participants will be evaluated before and after the intervention in terms of anthropometric measurements, biochemical parameters, and dietary habits. The study is being conducted at a private hospital in Bursa, Turkey, and is planned to be completed with a total of 40 participants (20 per group).

This study evaluates the antibacterial effectiveness of two different intracanal medicaments, Bio-C Temp and UltraCal XS , in mandibular molar teeth with chronic apical periodontitis. Intracanal bacterial load is assessed before and after root canal preparation, after intracanal medicament removal, and after final irrigation using droplet digital PCR.

This prospective observational study aims to investigate the effect of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Central sensitization, characterized by an increased responsiveness of the central nervous system to pain stimuli, has been associated with persistent pain and poor functional recovery in various musculoskeletal disorders. However, its impact on outcomes following arthroscopic rotator cuff repair has not been fully elucidated. Adult patients diagnosed with a rotator cuff tear by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic repair will be enrolled. Preoperative central sensitization will be assessed using the Central Sensitization Inventory (CSI), while pain intensity and shoulder function will be evaluated using the Visual Analog Scale (VAS) and the Shoulder Pain and Disability Index (SPADI), respectively. Clinical assessments will be performed preoperatively and at postoperative 3 months. The study aims to determine whether preoperative central sensitization is associated with postoperative pain and functional recovery after arthroscopic rotator cuff repair.