Clinical trials

Before kidney stone surgery with a flexible or semirigid ureteroscope, patients must read and sign a written consent form, but many patients find these forms long and hard to understand. This study tests whether listening to an audio recording of the same consent form, in addition to the usual written form and the surgeon's explanation, helps patients understand the operation better. It also asks whether it matters if the recording is read by a real urologist or produced by artificial intelligence (AI) from a clone of that same urologist's voice. Adults scheduled for their first ureteroscopy or retrograde intrarenal surgery at three hospitals in Turkey will be randomly assigned to one of three groups: (A) standard written consent only, (B) standard consent plus an audio recording read by a urologist, or (C) standard consent plus the same text produced by an AI-cloned version of the same urologist's voice. All three groups receive exactly the same information, word for word; only the way it is delivered differs. Patients in group C are told that the voice was produced by AI. The main outcome is a 10-question knowledge test on the content of the consent form, taken immediately after the consent process. Anxiety (State-Trait Anxiety Inventory) and satisfaction are also measured on the same day. No forms are completed on the day of surgery.

COMPARISON OF THE EFFECTS OF ERECTOR SPINAE PLANE (ESP) BLOCK AND QUADRO İLİAC PLANE (QIP) BLOCK ON POSTOPERATIVE OPIOID CONSUMPTION AND PAIN IN LUMBAR SPINAL SURGERY

Neonatal hyperbilirubinemia is a common condition in newborns and is frequently treated with phototherapy. In addition to standard treatment, non-pharmacological interventions such as massage and foot reflexology may help reduce bilirubin levels and improve physiological stability and stress in newborns. This randomized controlled trial aims to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature), and stress levels in neonates receiving phototherapy. A total of 105 newborns will be randomly assigned to three groups: foot reflexology, body massage, and control group. Interventions will be applied before phototherapy sessions, and outcomes will be measured before and after the intervention. The findings of this study are expected to provide evidence for the use of non-invasive complementary methods in reducing bilirubin levels and improving clinical outcomes in newborns.

The aim of this study is to evaluate whether the erector spinae plane (ESP) block reduces acute and chronic postoperative pain in patients undergoing spinal surgery. Participants will be assigned to study groups according to the study protocol. Postoperative pain will be evaluated using standardized pain assessment tools. Acute postoperative pain will be assessed using the Numeric Rating Scale (NRS), while chronic pain and its impact on daily life will be evaluated using the Brief Pain Inventory (BPI). Neuropathic pain symptoms will also be assessed using the Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS). The study aims to determine whether the use of ESP block as part of perioperative pain management can improve postoperative pain outcomes following spinal surgery.

Breastfeeding provides significant benefits for maternal and infant health; however, perceived insufficient milk supply is one of the most common factors associated with early breastfeeding discontinuation. Although the World Health Organization recommends exclusive breastfeeding for the first six months of life, breastfeeding continuation rates remain suboptimal in many countries, including Türkiye. This randomized controlled trial aims to evaluate the effect of breastfeeding education combined with a web portal and mobile application-supported breastfeeding counseling on perceived insufficient milk supply, breastfeeding intention, and breastfeeding adaptation among pregnant women. Women at 37-39 weeks of gestation will be randomly assigned to an intervention group or a control group. Participants in the intervention group will receive individualized breastfeeding education during pregnancy, educational materials, postpartum breastfeeding support, and web portal- and mobile application-supported breastfeeding counseling. Participants in the control group will receive routine hospital care. Data will be collected during pregnancy (baseline), immediately after birth, and at 1-, 3-, and 6-month postpartum follow-ups using validated scales assessing perceived insufficient milk supply, breastfeeding intention, and breastfeeding adaptation. Digital platform usage data, including the counseling topics accessed and the frequency of use, will also be evaluated in the intervention group. This study is supported as a research project and aims to develop an accessible digital breastfeeding support model that may improve breastfeeding confidence, reduce perceived insufficient milk supply, and promote breastfeeding adaptation and continuation.

Polycystic ovary syndrome (PCOS), also known as polyendocrine metabolic ovarian syndrome (PMOS), is the most common endocrinologic disorder to affect women. Despite this, the disease's pathophysiology remains unclear. This has hindered the diagnosis of the disease and the appropriate treatment for millions of individuals. The long-term health sequelae associated with PCOS, future directions, and areas of needed research in this often-overlooked disease. Women with PCOS may experience menstrual symptoms, increased stress, and difficulties in managing the physical and emotional effects of the condition. Supportive approaches that improve symptom management and quality of life may be beneficial in addition to routine care. The aim of this randomized controlled study is to evaluate the effect of mindfulness-based PCOS education on menstrual symptoms, stress levels, and quality of life in women with PCOS. The study will examine whether a structured mindfulness-based education program can support women in managing PCOS-related symptoms and improving their overall well-being. Women diagnosed with PCOS who meet the study eligibility criteria will be invited to participate. Participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a mindfulness-based PCOS education program, while those in the control group will receive routine care without it. Researchers will assess participants' menstrual symptoms, stress levels, and quality of life using validated measurement tools before and after the intervention. The findings of this study will provide information about the potential role of mindfulness-based education as a supportive approach in the management of PCOS and may contribute to the development of patient-centered education programs for women with PCOS.

This study aims to determine whether exposure to the odor of a newborn's own amniotic fluid affects postnatal adaptation and stress in healthy newborns born by cesarean section. Newborns will be randomly assigned to either an intervention group or a control group. Newborns in the intervention group will be exposed to a sterile material moistened with their own amniotic fluid, while newborns in the control group will be exposed to a sterile material moistened with distilled water. Postnatal adaptation, physiological responses, and stress levels will be evaluated at predetermined time points.

This randomized comparative study aims to evaluate the effectiveness of two gamified reinforcement strategies, Gimkit and Escape Room, on human papillomavirus (HPV) literacy, short-term retention, and gameful learning experiences among undergraduate nursing students. Following standardized theoretical instruction on HPV infection, participants will be randomly assigned to either a digital quiz-based gamification intervention (Gimkit) or a collaborative Escape Room activity. Outcomes will be assessed using the Human Papillomavirus Literacy Scale (HPV-LS) and the Gameful Experience Scale (GAMEX) at multiple time points, including baseline, post-theoretical instruction, post-intervention, and one-month follow-up.

This randomized controlled trial will be conducted to examine the effect of a multidimensional training program, to be implemented by a public health nurse, on the care burden and quality of life of primary caregivers of patients aged 65 and older.

The aim of this study is to determine the effect of verbal soothing applied by the researcher during routine nursing care in the neonatal intensive care unit on neonatal stress and physiological parameters. Newborns will be divided into two groups, an intervention group and a control group, using simple randomization. Verbal soothing will be applied to the intervention group during routine nursing care (eye care, oral care, diaper changing, probe placement, weight measurement, body care), while no intervention will be performed on the infants in the control group; only routine care procedures will be applied.

This randomized controlled trial aims to examine the effects of an Acceptance and Commitment Therapy (ACT)-based psychoeducation program on expressed emotion, perceived family burden, and psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center. The main questions this study aims to answer are: * Does ACT-based psychoeducation reduce expressed emotion among caregivers of patients with schizophrenia? * Does ACT-based psychoeducation reduce perceived family burden among caregivers of patients with schizophrenia? * Does ACT-based psychoeducation improve psychological flexibility among caregivers of patients with schizophrenia? Researchers will randomly assign eligible caregivers to either an intervention group receiving an 8-session ACT-based psychoeducation program or a control group receiving routine care. Participants will: * Complete assessment measures before the intervention (pre-test). * Participate in 8 ACT-based psychoeducation sessions if assigned to the intervention group. * Continue receiving routine care if assigned to the control group. * Complete assessment measures immediately after the intervention (post-test). * Complete follow-up assessments at 1 month and 3 months after the intervention.

Acute gastroenteritis (AGE) is among the most common reasons for paediatric emergency visits. Children with significant dehydration often require intravenous (IV) fluid therapy. Two main types of IV crystalloid solutions are currently used in clinical practice: 0.9% sodium chloride (normal saline, NS) and balanced crystalloids such as Isolyte-S, which contain acetate and gluconate as bicarbonate precursors. Normal saline has a high chloride content (154 mEq/L), which may worsen the metabolic acidosis already present in many children with acute gastroenteritis. Balanced crystalloids have a chloride content closer to that of plasma (98 mEq/L) and additionally contain acetate and gluconate, which are metabolised in peripheral tissues to consume hydrogen ions and thereby raise serum bicarbonate - a mechanism distinct from simply avoiding chloride overload. This study prospectively observes and compares early biochemical and clinical outcomes in children with acute gastroenteritis who receive one of these two fluid types as part of their routine clinical care. The treating physician independently decides which fluid to use; the research team does not influence this decision and does not order any additional tests or procedures. Laboratory values used as outcomes are drawn solely from blood tests obtained as part of standard care. The primary aim is to determine whether, at approximately 4 hours after IV fluid start, serum bicarbonate has changed more in children who received a balanced crystalloid compared with those who received normal saline. Secondary aims include comparing blood pH, chloride levels, need for additional IV boluses, time to first oral fluid intake, hospitalisation rate, and 72-hour return visits.

Introduction: Türkiye is far from the World Health Organization (WHO)'s target of reducing tobacco use prevalence by 30% by 2025. Most tobacco users consider quitting, and most have attempted to quit at least once. However, the success rate of quitting on one's own is quite low. Studies demonstrating that very brief tobacco cessation interventions delivered by healthcare professionals increase cessation rates have almost entirely been conducted in hospital settings. The aim of this trial is to investigate the effectiveness of implementing the 3A-OR (Ask - Assess - Advise - Offer Assistance - Record) very brief tobacco cessation intervention in routine primary care family medicine practice on the success of tobacco cessation. Methods/design: This protocol describes a two-arm, multicenter pragmatic trial for adolescent and adult tobacco users. The project will be carried out in family health centers in 21 study sites across the 12 statistical regions of Türkiye. In the intervention arm, volunteer family physicians will implement the 3A-OR very brief tobacco cessation intervention to their patients as part of their routine clinical practice. The intervention consists of the following steps: 'asking patients about their tobacco use status', 'assessing users' motivation to quit', 'advising quitting based on their motivation status', 'offering cessation assistance', and 'recording information regarding patients' tobacco use status and repeating the intervention at each patient contact'. Routine practice in family health centers will constitute the control group. Data will be collected using standard questionnaire forms at baseline and during follow-up interviews at 3, 6, and 12 months. Tobacco cessation rate and increase in smokers' motivation were the primary outcomes of the trial. Discussion: If the 3A-OR very brief tobacco cessation intervention is found to be effective, the results of this trial will provide evidence that will encourage the widespread use of the intervention in primary care family health centers. The study results are intended to be disseminated through the Family Medicine Academy Association website, conference presentations, and scientific publications.

This study will be conducted between May and August 2026 at Aydın Adnan Menderes University, Faculty of Health Sciences, with male individuals aged 18-35. For the study, cases will first be divided into 3 groups by computer-assisted randomization.The first group will be the Flex-i bar group, the second group will be the Theraband Flex bar group, and the third group will be the Sham bar group. Group 1 will perform the exercises with the Flex-i bar, while Group 2 will perform them with the Theraband Flex bar. The control group will perform the exercises with a rolling pin.After group assignment of cases is completed, demographic information such as age, height and weight of the participants will be recorded. Then, pre-exercise assessments of the participants will be conducted. The assessment will include proprioception, reaction time, power and upper extremity performance. Following the initial assessment, each group will perform their exercises with their own exercise material. Measurements will be repeated after the exercises. Measurements will be taken three times during the assessments and the best result will be recorded.

The HEMOVAR Study is a prospective observational study designed to evaluate the association between hemorrhoidal disease and lower extremity varicose veins. A total of 400 adult patients presenting to the general surgery proctology outpatient clinic of Aydın Adnan Menderes University Hospital will be included. The study will consist of two groups: 200 patients diagnosed with hemorrhoids and 200 patients with other non-hemorrhoidal benign proctologic conditions serving as controls. All participants will undergo routine clinical evaluation and demographic data collection. Cardiovascular surgeons will voluntarily perform physical examination and Doppler ultrasonography of the lower extremities to assess venous insufficiency and varicose veins. No experimental intervention or treatment will be applied. The study will not require any consumable materials and will not impose any additional financial burden on the hospital, patients, or the national health insurance system. The primary outcome is the prevalence of lower extremity venous insufficiency in patients with hemorrhoids compared with controls.

Vaccination is one of the most common invasive procedures performed on healthy infants and children. These procedures can cause pain and fear in children and anxiety in parents. This study will be conducted to determine the effect of using animal-shaped magic mirrors during vaccination on pain in children aged 1-4 years and anxiety in mothers.

The goal of this clinical trial is to learn about the effects of three different interventions-breastfeeding, using a stress ball, or wearing virtual reality (VR) goggles-on pain, anxiety, and stress during episiotomy repair (stitching) after childbirth. It also aims to examine how these methods affect a mother's comfort after the procedure. The main questions it aims to answer are: Does breastfeeding, using a stress ball, or using VR goggles lower the mother's pain and anxiety during the repair? Do these interventions reduce the mother's biological stress levels, measured by saliva cortisol tests? Do these methods lead to higher postpartum comfort levels for the mother in the first 24 hours after birth? Researcher will compare these three intervention groups to a "control group" (mothers receiving standard hospital care) to see which approach is most effective. Participants will: Be randomly assigned to one of four groups: Breastfeeding, VR Goggles, Stress Ball, or Standard Care. Use their assigned intervention throughout the entire episiotomy repair process. Provide saliva samples before and after the procedure to measure stress hormones (cortisol). Rate their pain and anxiety levels using clinical scales twice: once before the procedure begins and once immediately after it is finished. Complete a survey about their comfort levels between 6 and 24 hours after the delivery.

Febrile seizures are the most common seizure type in early childhood and usually occur during febrile illnesses. Although most febrile seizures are benign, the biological stress response during seizures is not fully understood. In particular, changes in thyroid hormones and stress-related hormones released by the sympathetic nervous system may play a role in seizure characteristics and clinical outcomes. This prospective observational study aims to evaluate the neuroendocrine response in children presenting with febrile seizures by measuring serum thyroxine (T4), epinephrine, and norepinephrine levels. These measurements will be obtained during the acute phase after seizure cessation and compared with levels measured at recovery and with febrile children without seizures. The study will examine the relationship between neuroendocrine marker levels and seizure characteristics such as seizure duration and recurrence, as well as clinical outcomes including length of hospital stay and need for pediatric intensive care unit admission. By improving understanding of the hormonal stress response associated with febrile seizures, this study aims to contribute to the knowledge of seizure pathophysiology in childhood and may help identify biological factors associated with more severe clinical courses.

This prospective, randomized, single-center, study aims to evaluate the postoperative analgesic effectiveness of bilateral Rhomboid Intercostal Block (RIB) in patients undergoing elective bilateral breast prosthesis surgery. Effective postoperative pain management is essential to improve patient comfort and reduce opioid consumption. Eligible patients aged 18-65 years with ASA physical status I-II will be randomly assigned to either receive ultrasound-guided bilateral RIB block in addition to standard general anesthesia or undergo surgery without any regional block (control group). All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia (PCA) with intravenous tramadol. The primary outcome of the study is total tramadol consumption within the first 24 postoperative hours. Secondary outcomes include postoperative pain scores at predefined time points, time to first analgesic requirement, need for rescue analgesia, incidence of nausea and vomiting, and block-related complications. The results of this study will help determine whether bilateral RIB block provides superior postoperative pain control compared to standard analgesic management alone in bilateral breast prosthesis surgery.

The aim of this study is to develop and evaluate the effectiveness of the Online Suicide Prevention and Intervention Training Program (Çevrimiçi İntihar Önleme ve Müdahale Eğitim Programı - ÇİÖMEP) for school counselors working in secondary education. Suicide is a major public health concern among adolescents, and school counselors play a vital role in early identification and intervention. This research uses a randomized controlled trial (RCT) design to determine if the training improves counselors' knowledge, perceived competence, and attitudes toward suicide prevention while reducing the stigma associated with suicidal behavior.

The goal of this clinical trial is to learn if a "blended" therapy format (combining face-to-face therapy sessions with a smartphone app) works to treat emotional disorders, such as depression and anxiety, in adults. It will also see if this blended format is feasible and acceptable for patients in primary care settings. The main questions it aims to answer are: Does the blended therapy format reduce symptoms of depression and anxiety? Is the blended format as effective as standard face-to-face therapy? Do participants find the smartphone app easy and helpful to use? Researchers will compare the blended therapy group to a standard face-to-face therapy group and a wait-list control group to see if the blended approach works well. Participants will: Attend therapy sessions based on the Unified Protocol (a type of cognitive-behavioral therapy) for about 10 weeks. Use a smartphone app to complete exercises and track their emotions (if assigned to the blended group). Answer questionnaires about their symptoms and quality of life at the beginning, at the end of treatment, and 3 months later.

The aim of this randomized controlled trial is to test the null hypothesis that parent education using an intraoral camera has no effect on children's oral hygiene levels, parental oral health literacy, or plaque accumulation on first permanent molars compared with standard verbal education. 40 children aged 5-7 and their parents will be randomly assigned to two groups. The intervention group will receive real-time visualization of dental conditions and brushing techniques using an intraoral camera, while the control group will receive standard verbal education using a brushing model. Outcomes include children's plaque and gum health and ICDAS caries scores. Secondary outcomes include Occlusal Plaque Index (OPI) on first molars. Assessments will be conducted at baseline and 1-month follow-up. This study tests whether intraoral camera-assisted education leads to better oral hygiene outcomes in children, improves parents' oral health literacy, and reduces plaque accumulation on the first permanent molars compared to standard verbal education.

Awake bruxism (daytime teeth clenching or jaw tension) is a common condition that can cause jaw pain, facial pain, muscle fatigue, and reduced quality of life. Although current treatments often focus on the jaw muscles and posture, recent research suggests that changes in the brain's sensory processing may also play an important role in bruxism-related pain. This randomized controlled trial aims to compare two physiotherapy-based treatment approaches with a wait-list control group in adults with awake bruxism. Participants will be randomly assigned to one of three groups: (1) somatosensory awareness-based training, (2) jaw and posture exercise therapy, or (3) a wait-list control group. The somatosensory training program focuses on improving body awareness and sensory perception of the face and jaw, while the exercise program includes jaw mobility, postural alignment, and cervical exercises. Both active interventions will be delivered over a 4-week period. Participants will be assessed at baseline, immediately after treatment, and during follow-up to evaluate changes over time. The main outcome of this study is orofacial pain intensity. Secondary outcomes include jaw function, sensory processing, muscle structure, oral parafunctional behaviors, and oral health-related quality of life. The results of this study may help improve physiotherapy-based treatment strategies for people with awake bruxism by addressing both physical and sensory aspects of the condition.

This is a randomized controlled experimental study evaluating the effects of oral motor intervention and chronobiological approach to feeding model applied to preterm infants on feeding readiness, transition to total oral feeding and body weight.

This observational, cross-sectional study aims to evaluate the current caries risk profiles of children who underwent dental treatment under general anesthesia (GA) for early childhood caries (ECC) between 2015 and 2020 at Aydın Adnan Menderes University, Faculty of Dentistry. A minimum of 44 systemically healthy children will be included. Caries risk will be assessed using the Cariogram model, incorporating clinical parameters (DMFT/dmft, Plaque Index, Gingival Index, probing depth), salivary factors (stimulated flow rate, buffer capacity), and standardized questionnaires covering diet, fluoride exposure, socioeconomic status, and dental visit history. Data will be collected in a single visit, analyzed using SPSS. The study aims to provide scientific evidence for long-term preventive strategies and oral health policies targeting high-risk pediatric populations treated under GA for ECC.