Clinical trials

This randomized controlled study aims to evaluate the effect of mandala art therapy applied before cesarean section on surgical fear and cortisol levels in high-risk pregnant women. Participants will be randomly assigned to intervention and control groups. The intervention group will receive mandala art therapy prior to surgery, while the control group will receive standard care. Surgical fear levels and salivary cortisol levels will be measured to assess the outcomes.

Aim: This study was conducted to examine the effects of breathing exercises on maternal anxiety, well-being, and infant stress. Materials and Methods: The research was initiated in a hospital in eastern Turkey between November 2024 and November 2026, after obtaining ethical committee and institutional approvals. The study population consisted of mothers whose babies were hospitalized in the neonatal intensive care unit (NICU) of that hospital.The generally available G\*Power 3.1.9.7 for Windows software was used to calculate the sample size. Similar literature studies were referenced when determining the sample size of the research (Shamsdanesh et al., 2023). Furthermore, after the research is completed, a post-hoc power analysis will be performed on the main dependent variable, maternal anxiety level (MAL), to determine the power of the study (approximately 35 experimental, 35 control). The aim of the research is to ensure that the resulting sample size has sufficient statistical power to reveal the effect being examined. The research data is collected using a Demographic Information Form, prepared by the researcher through a literature review, the State and Trait Anxiety Inventory, the Psychological Well-being Scale, and the Neonatal Stress Scale. Mothers perform this exercise three times a day for two days (days 1 and 2), under the supervision of a researcher. The four-square breathing exercise is a non-pharmacological pain reliever that has been shown to be beneficial in conditions other than pain. Each breathing exercise lasts 5-10 minutes. Mothers in the experimental group are given a questionnaire before the start of the study and after the exercise on days 1 and 2. Mothers in the control group are given only a questionnaire before the start of the study, at the end of day 1, and at the end of day 2. Mothers in the control group do not perform the four-square breathing exercise and receive routine hospital care. At the end of both days, mothers in the control group who wish to practice the breathing exercise are given the opportunity to do so.

Anxiety is a state of worry and apprehension caused by internal and external threats. High preoperative anxiety levels have been associated with increased anesthetic requirements, higher morbidity, and mortality rates. In adult patients undergoing various surgical procedures, preoperative anxiety rates have been reported to range from 11% to 80%. Most studies show that postoperative anxiety levels are related to preoperative anxiety levels. In patients undergoing general anesthesia, anxiety levels increase a few days after surgery as issues related to recovery and pain become apparent. Patients with high postoperative anxiety levels have also been reported to have a higher rate of medical complications.

This study aims to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in achieving adequate anesthesia in pediatric patients presenting with acute dental pain and requiring emergency endodontic treatment of mandibular permanent molars. Achieving profound anesthesia in such cases can be challenging due to acute inflammation. Participants will be randomly assigned to receive either conventional IANB or digital anesthesia. Pain perception during the procedure will be assessed using validated pain scales. In addition, physiological parameters including heart rate and blood pressure will be recorded to evaluate the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia. The findings of this study are expected to provide evidence-based guidance for selecting the most effective and comfortable anesthesia technique in pediatric dental patients.

This study aims to investigate the relationship between motor imagery skills and neglect level, upper extremity motor function, activities of daily living, quality of life, lateralization performance, and mental timer performance in individuals with stroke. Individuals with stroke who meet the inclusion criteria and voluntarily agree to participate will be evaluated. Demographic and clinical information of the participants will be recorded on an assessment form prepared by the researcher. Upper extremity motor functions will be assessed using the Fugl-Meyer Upper Extremity Motor Assessment Scale and the Wolf Motor Function Test; activities of daily living will be assessed using the Modified Barthel Index; and quality of life will be assessed using the Stroke-Specific Quality of Life Scale. Motor imagery skills will be measured using the Kinesthetic and Visual Imagery Questionnaire and a mental timer task; upper extremity lateralization performance will be assessed using the Recognise™ application. Neglect level will be assessed using the Catherine Bergego Scale, the Line Splitting Test, and the Star Erase Test. The data obtained will be statistically analyzed to examine the relationships between motor imagery skills and other clinical variables.

This randomized controlled study aims to evaluate the effect of motivational interviewing on menopause myths and posttraumatic growth in postmenopausal women. Participants will be randomly assigned to an intervention group receiving four weekly motivational interviewing sessions or a control group receiving usual care. Outcomes will be assessed before and after the intervention using validated scales.

This prospective cross-sectional clinical study aims to investigate the relationship between circadian rhythm disruption and periodontal inflammation by evaluating circadian clock protein levels, inflammatory (IL-1beta) and anti-inflammatory (IL-10) cytokine levels in gingival crevicular fluid (GCF) of individuals with and without circadian rhythm disruption. Participants aged 20-50 years will be classified into four groups based on their circadian rhythm status (disrupted/normal) and gingival health status (gingivitis/healthy). Clinical periodontal parameters including plaque index, gingival index, bleeding on probing, and probing depth will be assessed. Circadian rhythm status will be determined using validated questionnaires (Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire). Night-shift workers will represent the circadian rhythm disruption group. GCF samples will be analyzed for circadian clock proteins (BMAL-1, CLOCK, PER-1, PER-2, PER-3, CRY-1, CRY-2, REV-ERB-beta, MTNR1B) and cytokines (IL-1beta, IL-10) using ELISA. Serum cortisol and melatonin levels will be measured for biochemical verification of circadian rhythm status. Gingivitis groups will receive standard periodontal treatment and be re-evaluated at 2 weeks post-treatment. A total of 116 participants (29 per group) are planned for enrollment.

Patients in intensive care units experience significant physiological and psychological stress due to life-threatening conditions and invasive treatments. This randomized controlled study aims to examine the effects of virtual art therapy on physiological parameters, delirium risk, anger, anxiety, and mental-spiritual recovery in 62 patients in the coronary ICU of Malatya Training and Research Hospital. Data will be collected using validated scales and analyzed with appropriate parametric or non-parametric tests. The study seeks to evaluate the effectiveness and applicability of virtual art therapy as a technology-based complementary intervention in intensive care settings.

The purpose of this study was to determine the effects of mindfulness-based self-compassion training provided to primiparous women on fear of childbirth, pregnancy stress, and comfort. Research Hypotheses H1a: Mindfulness-based self-compassion training provided to primiparous women reduces fear of childbirth. H1b: Mindfulness-based self-compassion training provided to primiparous women reduces pregnancy stress. H1c: Mindfulness-based self-compassion training provided to primiparous women increases comfort.

This randomized controlled study aims to evaluate the effect of Mindfulness-Based Stress Reduction (MBSR) training given to adolescent pregnant women and their partners on fear of childbirth, maternal and paternal bonding, and breastfeeding success. Adolescent pregnancy is associated with increased stress, fear of childbirth and parenting anxiety, which negatively affect mother-infant and father-infant bonding and breastfeeding outcomes. MBSR training is expected to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success in adolescent pregnant women and their partners compared to the control group receiving routine care.

This randomized controlled trial aims to evaluate the effect of a midwife-led digital follow-up program on postpartum depression, perceived social support, and breastfeeding self-efficacy in women who will undergo cesarean section. Participants will be randomly assigned to either an intervention group that will receive structured face-to-face education followed by a 4-week digital follow-up program, or a control group that will receive routine postpartum care. Data will be collected at baseline (postpartum day 1), at 1 week, and at 4 weeks postpartum using validated measurement tools. The study will provide evidence on the effectiveness of continuous, midwife-led digital support in improving maternal psychological well-being and breastfeeding outcomes in the early postpartum period.

Participants will complete five sessions, including one familiarization and baseline session and four experimental conditions (placebo, L-tyrosine, caffeine, and combined supplementation). The baseline session will include resting measurements. The experimental conditions will be performed in a randomized, counterbalanced crossover design with a washout period of at least 72 hours between sessions.

The aim of this study is to evaluate the clinical, microbiological, and biochemical effects of Morus nigra (black mulberry) mouthwash when used as an adjunct to non-surgical periodontal treatment (scaling and root planing - SRP) in patients with generalized gingivitis. Participants will be randomly assigned to two groups: one receiving SRP only, and the other receiving SRP plus Morus nigra mouthwash twice daily for 14 days. Clinical parameters, cytokine levels in gingival crevicular fluid (TNF-alpha, IL-1beta, IL-10), and subgingival bacterial load will be assessed at baseline, 1 month, and 3 months.

This study investigated the effects of a virtual reality-based motor imagery intervention integrated into a conventional exercise programme on pain outcomes (pain intensity, central sensitisation, pressure pain threshold, galvanic skin response, pain catastrophising), quality of life, sleep quality, fatigue, psychological outcomes (Hospital Anxiety and Depression Scale), imagery ability and patient satisfaction.

Colorectal cancer is one of the most commonly diagnosed malignancies worldwide and a leading cause of cancer-related morbidity and mortality. Its global incidence continues to increase, with a substantial proportion of cases diagnosed at advanced stages, which adversely affects prognosis. Patients diagnosed at an early stage and treated with surgery have significantly better long-term survival outcomes. Five-year survival rates are approximately 90% for stage I disease, decreasing to around 70% in stage II and 60% in stage III, and dropping to as low as 8% in stage IV disease. Advanced age, family history, and environmental exposures are well-established risk factors for colorectal cancer. In addition, modifiable lifestyle factors-including smoking, physical inactivity, unhealthy dietary patterns, and obesity-have been shown to significantly increase the risk of disease. Although surgical resection remains the cornerstone of curative treatment in colorectal cancer, long-term outcomes are influenced not only by tumor stage but also by various patient-related factors, including comorbidities, functional capacity, and respiratory reserve. Functional status, which reflects a patient's ability to perform activities of daily living, is a key determinant of postoperative recovery and long-term outcomes. Reduced functional capacity has been associated with poorer long-term survival, diminished quality of life, and increased late morbidity. Therefore, objective preoperative assessment of functional status is considered essential for predicting long-term prognosis. Respiratory function also plays a critical role, particularly in patients undergoing abdominal surgery. Impaired pulmonary capacity increases the risk of postoperative pulmonary complications, prolongs hospital stay, and may indirectly affect long-term survival. However, studies evaluating the impact of preoperative respiratory parameters on long-term outcomes in patients with colorectal cancer remain limited. Furthermore, comprehensive analyses integrating both functional capacity and respiratory function are scarce in the current literature. Therefore, further investigation in this area is warranted. The aim of this study is to evaluate the impact of functional status and respiratory parameters on long-term clinical outcomes in patients with colorectal cancer. H0: There is no statistically significant association between functional status, respiratory parameters, and long-term clinical outcomes in patients with colorectal cancer. H1: There is a statistically significant association between functional status, respiratory parameters, and long-term clinical outcomes in patients with colorectal cancer.

This randomized controlled, single-blind, quasi-experimental study primarily aims to investigate the effects of unilateral resistance exercise applied without directly loading the affected shoulder on muscle strength and upper extremity function in individuals with frozen shoulder. Additionally, the study seeks to examine the effects on joint range of motion, quality of life, and activities of daily living. The study will be conducted among individuals diagnosed with frozen shoulder at the Physiotherapy and Rehabilitation Outpatient Clinic of Malatya Battalgazi State Hospital. The data collection process is planned to be completed between February 2026 and December 2026. Participants will be selected from the relevant population using a non-probability convenience sampling method. Individuals meeting the inclusion criteria will be enrolled after providing written informed consent. The study will be carried out in accordance with the principles of the Declaration of Helsinki. Participants will be randomly assigned to either the control or intervention group. The study will include individuals aged 18-65 years with a diagnosis of unilateral primary or secondary frozen shoulder, presenting with more than 50% restriction in at least one of the following shoulder movements compared to the unaffected side: external rotation, abduction, or flexion, and with more than 30% limitation in joint range of motion in at least two movement planes. Individuals with concomitant shoulder trauma (e.g., rotator cuff injury), bilateral shoulder involvement, acromioclavicular joint osteoarthritis, prior treatment for frozen shoulder, psychiatric disorders that may affect compliance with medical or physical therapy interventions, concomitant neurological conditions, or a Mini-Mental State Examination (MMSE) score below 24 will be excluded from the study.

Purpose of the study: Ankylosing spondylitis (AS) is a chronic disease that affects the spine and joints, causing pain, stiffness, fatigue, and reduced quality of life. Exercise is known to help reduce pain and improve function in individuals with AS. However, the most effective type and method of exercise are not fully known. This study aims to compare the effects of different telerehabilitation methods-synchronous (live video) and asynchronous (pre-recorded video)-on disease activity, physical function, mobility, fatigue, quality of life, kinesiophobia (fear of movement), and pain levels in individuals with AS. Study design and methods: This is a randomized controlled experimental study. Participants will be randomly assigned to one of three groups: Synchronous telerehabilitation: Exercise sessions via live video, 3 times per week for 8 weeks. Asynchronous telerehabilitation: Exercise sessions via pre-recorded videos, 3 times per week for 8 weeks. Control group: Exercise instructions provided in a brochure. All groups will perform exercises for approximately 40-50 minutes per session, focusing on flexibility, strength, posture, balance, coordination, and functional movements. Participants will be evaluated before the intervention (week 0) and after 8 weeks for disease activity, physical function, mobility, fatigue, quality of life, kinesiophobia, and pain during rest, movement, and sleep. Participants: The study will include adults aged 18-65 years diagnosed with AS at least one year prior, able to use a smartphone, and willing to participate. Individuals who are pregnant, have serious comorbidities, recent surgery, or conditions affecting mobility will be excluded. Expected benefits: The study will identify which telerehabilitation method is more effective for individuals with AS. telerehabilitation may provide easier access to treatment, improve adherence to exercise programs, and contribute to better disease management and quality of life.

The concept of genital self-image first emerged alongside genital identity. Womens perceptions of their genital self encompass their feelings and subjective thoughts about their sexual organs. One of the most significant problems resulting from a negative genital self-image is sexual health. It has been reported that genital self-perception and self-image are related to sexual health. Another study that examined the effects of viewing various vulvar photographs on womens genital attitudes found that women had relatively positive genital self-images before viewing the photographs, but their perceptions became even more positive after viewing them. This study aims to examine the impact of education on genital appearance satisfaction and sexual quality of life in women with low genital self-image. It is hypothesized that women with low genital self-image who receive education will have more knowledge about genital anatomy, which will positively influence their genital appearance, genital self-image, and consequently improve their sexual quality of life. The study is a randomized controlled experimental research. The research will be conducted women aged 18-49 years with low genital self-image who are registered at a Family Health Center (FHC). Data collection tools in the study will include a socio-demographic data form prepared by the researchers, the Genital Self-Image Scale, the Genital Appearance Satisfaction Scale, and the Sexual Quality of Life Scale. The SPSS 24.0 software package is planned to be used for data analysis. Descriptive statistics such as mean, standard deviation, number, and percentage will be used in the analysis of the quantitative data. The normality of the data distribution will be assessed, and parametric or non-parametric tests will be applied based on the distribution. Additionally, regression analyses will be used to evaluate the effect, and a significance level of 0.05 will be accepted for the entire study.

Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airflow limitation, progressive dyspnea, and peripheral muscle dysfunction, significantly impairing functional capacity and quality of life. Although the combined implementation of aerobic and resistance exercises is recommended in pulmonary rehabilitation programs, early-onset ventilatory limitation in individuals with COPD often hinders tolerance to high exercise intensities. This limitation increases the need for alternative exercise approaches targeting peripheral muscle adaptations. Low-load blood flow restriction training (LL-BFRT), which enables improvements in muscle strength with low mechanical loads, has emerged as a potential option for this patient population. However, evidence regarding the effects of LL-BFRT in individuals with COPD-particularly on upper extremity muscles-remains limited. The aim of this study is to comparatively investigate the effects of LL-BFRT and sham-BFRT, both administered in addition to an aerobic exercise program in individuals diagnosed with stage II and III COPD, on upper extremity muscle strength, upper extremity functional capacity, activities of daily living performance, quality of life, functional exercise capacity, muscle oxygenation, and respiratory parameters. The study is designed as a randomized controlled, single-blind, quasi-experimental interventional trial. The expected outcomes are that LL-BFRT may enhance upper extremity muscle strength and functional capacity, improve activities of daily living and quality of life, and increase exercise tolerance due to its applicability at low mechanical loads. Furthermore, findings related to muscle oxygenation and respiratory parameters are anticipated to provide clinical evidence regarding the physiological effects of LL-BFRT on peripheral muscle adaptations. These results are expected to guide the integration of LL-BFRT as an alternative and safe approach in upper extremity exercise prescription within pulmonary rehabilitation programs, support clinical decision-making processes, and establish a scientific foundation for future research.

Diabetes is a significant health problem affecting approximately half a billion people worldwide, reaching alarming levels. Diabetic foot ulcers are among the most common and serious complications of diabetes. Diabetes is the most common cause of end-stage renal failure, and diabetic nephropathy is identified as a major risk factor for foot ulcers and amputation. The health belief model is a model that explains behavior. Focusing on the necessary motivational resources for the development of positive health behaviors in individuals is crucial for positive patient outcomes in the education of diabetic hemodialysis patients. It is necessary for hemodialysis nurses to educate diabetic patients on foot care knowledge, improve foot care behaviors, and prevent the development of foot ulcers and lower extremity amputations. However, the lack of studies in the literature on nurse-led foot care education interventions based on the health belief model for diabetic patients undergoing hemodialysis constitutes the strength and unique aspect of this study. The research will be conducted using a randomized controlled pretest-posttest design.

This randomized controlled study will evaluate the effectiveness of an online Watch-Summarize-Question-Ask (WSQA) learning method on nursing students' knowledge, skills, attitudes, and behaviors related to patient fall prevention and management. Sixty-six nursing students will be randomly assigned to intervention and control groups. Both groups will receive standard patient safety education, while the intervention group will additionally participate in an online, evidence-based fall prevention training program structured according to the WSQA method, including video-based learning, summarization, question generation, and interactive discussions. Outcomes will be assessed using validated instruments measuring fall management knowledge, self-efficacy, attitudes toward fall prevention, care planning performance, and student satisfaction. The study aims to determine the effectiveness of an innovative educational approach to improve fall prevention competencies and enhance the quality and safety of nursing care.

This randomized controlled study will compare the effects of the ShotBlocker device and the Helfer Skin Tap Technique on pain and fear during intramuscular hormone injections in premenopausal and postmenopausal breast cancer patients. Ninety-nine participants will be randomly assigned to three groups (ShotBlocker, Helfer, control). All injections will be administered by the same nurse using standardized procedures. Pain will be assessed with the Visual Analog Scale, and fear with the Injection Fear Scale. The study aims to identify effective nonpharmacological methods to enhance patient comfort, support treatment adherence, and improve nursing care quality.

This study investigates the effect of cold spray and Buzzy devices on pain and fear experienced during penicillin injections. There are three groups: a cold spray and Buzzy device, and a control group. Penicillin injections are commonly used in clinical practice and can cause discomfort, pain, and fear, particularly in patients receiving intramuscular injections. Cold spray and Buzzy devices are non-pharmacological methods that can help reduce pain and fear by providing a cooling effect and vibration at the injection site. Participants will be randomly assigned to one of the study groups, and their pain and fear levels during injection will be assessed using standardized measurement tools. The results of this study are expected to contribute to improving patient comfort and supporting the use of simple, non-invasive methods to reduce pain and fear during injections.

Menopause is a natural transition characterized by vasomotor symptoms such as hot flashes and sleep disturbances, which can significantly impair quality of life. Non-pharmacological interventions are increasingly recommended for women who cannot or prefer not to use hormone therapy. Mindfulness-Based Stress Reduction (MBSR) is a structured behavioral intervention that has shown beneficial effects on stress-related symptoms and sleep quality; however, evidence regarding its effects on menopausal symptoms remains limited. This randomized controlled trial aims to evaluate the effectiveness of an 8-week MBSR program on hot flash frequency and severity and sleep quality in menopausal women. A total of 90 menopausal women will be randomly assigned to either an intervention group receiving the MBSR program or a control group receiving no intervention. Participants in the intervention group will attend weekly sessions and engage in mindfulness practices, including breathing awareness, body scan, and stress management techniques. Primary outcomes include changes in hot flash frequency and severity and sleep quality, assessed using validated self-report measures. The findings of this study are expected to contribute to evidence-based, non-pharmacological management strategies for menopausal symptoms.

The aim of this cross-sectional observational study is to comprehensively examine the effects of adherence to a gluten-free diet on cognitive, motor, and psychosocial functions in adolescents aged 8-18 years diagnosed with celiac disease. In this context, dual-task gait performance, cognitive processing speed and attention, working memory and executive functions, muscle strength, quality of life, and fatigue levels of individuals with celiac disease who are adherent or non-adherent to a gluten-free diet will be compared with those of healthy peers. In addition, sleep patterns, pubertal development, socioeconomic indicators, and serological markers will be taken into account to evaluate the unique effects of diet adherence on neurocognitive and functional outcomes. All assessments will be conducted in accordance with a predefined standardized protocol. The order of measurement instruments will be randomized to minimize potential bias. Inclusion criteria will consist of being between 8 and 18 years of age, having a celiac disease diagnosis confirmed by serology, being followed with this diagnosis for at least six months, and obtaining written informed consent from both the participant and their parent/guardian. For the healthy control group, participants must be within the same age range and have no history of chronic neurological, psychiatric, or gastroenterological conditions. Data analysis will be performed using SPSS