Clinical trials

This prospective observational case-control study aims to compare gingival crevicular fluid (GCF) biomarker profiles between children and young adults diagnosed with gingivitis. A total of approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded as they represent a transitional pubertal period characterized by significant hormonal fluctuations that may influence inflammatory responses and confound biomarker levels. Clinical periodontal parameters including gingival index, plaque index, bleeding on probing, and probing depth will be recorded. In addition, GCF samples will be collected from a standardized tooth and analyzed for levels of IL-1β, TNF-α, IL-10, and MMP-8 using enzyme-linked immunosorbent assay (ELISA). The primary objective of the study is to evaluate and compare inflammatory and anti-inflammatory cytokine profiles between the two age groups. The findings may contribute to understanding age-related differences in gingival inflammatory responses and the potential role of hormonal transition in periodontal disease expression during childhood and early adulthood.

Childbirth is a significant life event with important physical and psychological effects on pregnant women. Due to uncertainty during pregnancy, many women experience fear of childbirth. Fear of childbirth is a common condition that may negatively affect maternal well-being. Therefore, various psychosocial interventions have been developed to reduce this condition. Mindfulness-based approaches and psychoeducation programs are considered effective methods for reducing stress, anxiety, and fear by promoting non-judgmental awareness of the present moment. This study is designed as a randomized controlled experimental trial. The study population will consist of pregnant women attending the Obstetrics and Gynecology Outpatient Clinic of Niğde Ömer Halisdemir Training and Research Hospital who meet the inclusion criteria. The sample size was calculated using G\*Power 3.1.9.7 software. Based on an effect size of f = 0.38, 80% statistical power, and a 5% significance level, a minimum of 30 participants was required. Considering a 20% potential dropout rate, a total of 72 pregnant women (36 intervention and 36 control) will be included in the study. The inclusion criteria are being between 18 and 40 years of age, having a first pregnancy, being between 20 and 34 weeks of gestation, having a singleton and healthy pregnancy, being able to communicate in Turkish, and scoring 38 or higher on the Wijma Delivery Expectancy/Experience Questionnaire (Version A). Women with high-risk pregnancies, a history of psychiatric disorders, illiteracy, communication problems, or unwillingness to participate will be excluded. Withdrawal during the study, development of pregnancy complications, or inability to continue the intervention will be considered exclusion criteria. Data will be collected using a Sociodemographic Information Form, the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ A), the Self-Perception Scale for Pregnant Women, and the Spiritual Well-Being Scale. The W-DEQ A measures fear of childbirth, the Self-Perception Scale assesses maternal and body perception during pregnancy, and the Spiritual Well-Being Scale evaluates the level of spiritual well-being. At the beginning of the study, eligible participants will be informed about the research and written informed consent will be obtained. Data collection forms will first be administered face-to-face. Pregnant women scoring 38 or above on the W-DEQ A will then be randomly assigned to intervention and control groups using a computer-based randomization method (randomizer.org). The intervention group will receive a mindfulness-based psychoeducation program adapted according to the Transtheoretical Model. The intervention will be delivered in group sessions of 6-10 participants, twice a week for 4 weeks, with each session lasting approximately 45-60 minutes. The program includes psychoeducation about pregnancy and childbirth, mindfulness exercises, emotional awareness activities, and coping strategies for fear of childbirth. The control group will receive routine obstetric care only. Post-intervention assessments will be conducted in both groups using the same measurement tools. Data analysis will be performed using SPSS version 25.0. Descriptive statistics will be calculated, and depending on data distribution, independent samples t-test, paired samples t-test, ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and chi-square test will be used. The level of statistical significance will be set at p \< 0.05. The aim of this study is to evaluate the effect of a mindfulness-based psychoeducation intervention based on the Transtheoretical Model on fear of childbirth, self-perception, and spiritual well-being in pregnant women experiencing fear of childbirth.

In the early stages of life, newborns are dependent on caregivers to meet their basic needs for survival, feeding, and care. Generally, mothers assume primary responsibility for meeting their infants' basic needs and providing care, while fathers take on a supporting role. Both mothers and fathers actively contribute to the baby's healthy emotional development. This study, planned with fathers of 4-6 month old infants, addresses the lack of quantitative evidence regarding the relationship between fathers' involvement in infant care and infants' sensory processing.

This randomized controlled trial evaluates whether acupressure education provided to mothers within the first 48 hours postpartum improves exclusive breastfeeding rates at 6 months compared with standard postpartum care alone. Mothers in the intervention group will receive structured education on self-administered acupressure at selected points and will be encouraged to continue home-based practice, while the control group will receive standard breastfeeding support. Participants will be followed for 12 months to assess breastfeeding continuation, breastfeeding self-efficacy, breastfeeding quality, and breastfeeding-related outcomes.

This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on social jet lag, sleep patterns, and sleep quality in female health sciences students. Participants will be randomly assigned to either a self-acupressure intervention group or a sham self-acupressure control group. The intervention will be performed daily for 12 weeks. Outcomes will be assessed at baseline and at the end of the intervention period, with the primary outcome being the change in social jet lag. Secondary outcomes include changes in sleep quality, daytime sleepiness, and participant blinding assessment.

Background: Sensory stimulation is a treatment that uses auditory, visual, tactile, gustatory, and olfactory stimuli, as well as balance and position modes, with intensity and frequency adjusted to the patient's individual thresholds to increase the frequency of arousal, awareness, and pronounced behavioral responses. Studies have shown that sensory stimulation, especially when applied from the beginning of the patient's hospitalization, can shorten the average length of stay and reduce patient anxiety. Among the TIT methods applied by nurses, touch, music therapy, and aromatherapy are included as applications that can be applied to the sensory input problems of intensive care patients and can positively affect their sensory perceptions.Objective: This study is planned to be conducted as a randomized controlled single-blind study to determine the effect of a sensory stimulation program performed with aromatherapy massage applied twice daily for 7 days with a mixture of orange, patchouli, and rosemary oil (7 drops of sweet orange oil, 5 drops of patchouli oil, and 3 drops of rosemary oil in 50 ml of jojoba oil) on the cognitive sensory perception level of patients monitored on mechanical ventilation or oxygen in the ICU.Method: In the study, all patients hospitalized in the tertiary care ICU of the University's Training and Research Hospital will constitute the population. Randomized sampling method will be used in the study. Sample size; G\*power 3.5.1. In the power analysis performed with the software package, it is planned that each group will consist of at least 20 people to determine an effect size of 1% with an alpha risk of 0.05 and a power of 0.80 in line with the literature. The data collection tools to be used are: Patient Identification Form, Patient Monitoring Form, Medication Monitoring Form, Glasgow Coma Scale, Rancho Los Amigos Cognitive Function Scale. In Intervention Group 1, massage will be performed by the lead researcher ICU nurse, and the sensory stimulation program will be performed by a trained family member. In Intervention Group 2, massage will be performed by the lead researcher ICU nurse, and the sensory stimulation program will be performed by a nurse. Routine care will be provided to the control group. Since the groups are compared, the independent samples t-test and the Shapiro-Wilk test, which are parametric tests, will be used for evaluation.

One of the most prominent indicators of prenatal androgen exposure is considered to be the ratio of second and fourth finger lengths (2D:4D). The 2D:4D finger ratio refers to the ratio of the length of the second finger (2D; index finger) and the fourth finger (4D; ring finger). Evidence suggests that 2D:4D is developmentally stable and stabilizes from the second trimester of pregnancy. It has been reported that the 2D:4D ratio correlates positively with estrogen and negatively with testosterone. In both sexes, prenatal testosterone levels are inversely related by a 2D:4D ratio, which does not change with age. Androgens can have direct trophic effects on target cells or indirectly affect neuronal growth through neurotrophic mediators released locally by steroid-sensitive neuronal or glial cells. Prenatal testosterone can have long-term organizational effects on the structure and function of various body systems (e.g., cardiovascular and musculoskeletal systems) that are important for physical activity and exercise.

This prospective study aims to evaluate the clinical findings of bruxism and masseter muscle thickness in children aged 10-12 years using ultrasonography, and to assess the effects of night guard use on these parameters over time.

This study aims to evaluate and compare the effects of aromatherapy and music therapy on anxiety levels in children undergoing intraoral radiographic examination for the first time. Dental anxiety is a common problem in pediatric patients and can negatively impact cooperation and treatment outcomes. Children included in the study will be randomly assigned to four groups: aromatherapy and music group, aromatherapy group, music therapy group, or control group. In the aromatherapy group, children will be exposed to a selected essential oil (lavender oil) before the radiographic procedure, while in the music therapy group, children will listen to calming music through a speaker. The group receiving both aromatherapy and music therapy will listen to music while being exposed to the essential oil. The control group will receive standard care without any additional intervention. Anxiety levels will be assessed before and after the radiographic procedure using the Facial Imaging Scale (FIS). Simultaneously, pulse rate will be measured before and after the procedure using a finger pulse oximeter. The primary aim is to determine whether aromatherapy, music therapy, or a combination of both is more effective in reducing anxiety compared to the control group. The findings of this study are expected to contribute to the development of simple, non-invasive, and cost-effective methods to improve the comfort and cooperation of pediatric patients during dental radiographic procedures.

Spinal anesthesia for elective cesarean section is frequently associated with hemodynamic instability and postoperative complications such as postoperative nausea and vomiting (PONV) and delayed gastrointestinal recovery. Although intraoperative fluid administration is routinely used to prevent spinal-induced hypotension, the optimal fluid strategy remains unclear. Both restrictive and liberal fluid approaches may influence maternal hemodynamics and postoperative outcomes through different physiological mechanisms. This prospective, single-center, randomized controlled trial aims to compare restrictive (≤3 mL/kg/h) and liberal (\>3 mL/kg/h) intraoperative crystalloid fluid strategies in patients undergoing elective cesarean section under spinal anesthesia. The primary outcome is the incidence of PONV within the first 24 hours postoperatively. Secondary outcomes include postdural puncture headache (PDPH), time to first flatus, hypotension frequency, and vasopressor requirements.

This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on menstrual pain severity and premenstrual symptoms in women aged 18-30 years with primary dysmenorrhea. Participants will be randomly assigned to either a self-acupressure intervention group or a sham self-acupressure control group. The intervention will be applied during the premenstrual and menstrual periods over approximately six months. The primary outcome is the change in menstrual pain severity, and secondary outcomes include changes in premenstrual symptom severity, analgesic use, and menstruation-related activity limitation.

A review of the literature has focused primarily on the cognitive and motor development of children with congenital hypothyroidism, but no studies on sensory processing skills have been found. Considering the age range of the groups studied, studies conducted in the early stages of life are rare. This planned study aims to examine the neurological status, motor development, and sensory processing skills of infants aged 6-18 months, considering early synaptogenesis.

This study looks at whether a special wound dressing containing ozonated oil can reduce early wound inflammation after open inguinal hernia surgery. Open inguinal hernia repair is a common operation, and although infection rates are low, many patients experience redness, swelling, tenderness, or discomfort at the surgical site during the first days after surgery. Participants undergoing elective open inguinal hernia repair will be randomly assigned to receive either an ozonated oil-impregnated dressing or a standard sterile dressing after the operation. The main outcome is the level of wound inflammation measured on the third day after surgery. Other outcomes include wound temperature, pain levels, cosmetic healing, and wound-related problems during the first 30 days. The ozonated oil used in this study is a CE-certified medical product that is already used in routine wound care. This pilot study aims to provide preliminary data to help determine whether ozonated oil dressing may improve early wound healing compared with standard care.

This project aims to evaluate the effects of acupressure applied to elderly individuals with painful diabetic peripheral neuropathy (DPN) on neuropathic symptoms, balance confidence, fear of falling, and quality of life. This project will be conducted using a mixed methodology integrating quantitative and qualitative methods. Elderly individuals will be randomly assigned to an acupressure or placebo control group. The acupressure group will receive a total of 10 sessions of acupressure over one month. Outcome measures include assessments of neuropathic pain and symptoms, balance confidence, fear of falling, and quality of life. Appropriate statistical tests will be used to analyze the quantitative data obtained from the study, while content analysis will be used for the qualitative data.

This study was planned to evaluate the effect of haptonomy practice for primiparous pregnant women and their partners on prenatal attachment and fear of childbirth.

Adolescent idiopathic scoliosis (AIS) is a spinal condition that develops during adolescence and often requires long-term conservative treatment, including scoliosis-specific therapeutic exercises. The success of exercise-based treatment largely depends on adolescents' motivation to start and continue exercising. However, exercise motivation has not been adequately evaluated in adolescents with idiopathic scoliosis using validated tools specific to this population. The Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) is a widely used questionnaire based on Self-Determination Theory that assesses different types of motivation toward exercise. Although the Turkish version of the BREQ-2 exists, its validity and reliability have not yet been examined in adolescents with idiopathic scoliosis. The purpose of this study is to evaluate the validity and reliability of the Turkish version of the BREQ-2 in adolescents diagnosed with idiopathic scoliosis. Adolescents aged 10-19 years who have been participating in scoliosis-specific therapeutic exercise programs for at least two months will be invited to complete online questionnaires. The results of this study will help determine whether the BREQ-2 is an appropriate tool for assessing exercise motivation in this population and may support the development of individualized motivational strategies in scoliosis rehabilitation.

This study evaluates whether Transcutaneous Electrical Nerve Stimulation (TENS) improves postoperative pain and sleep quality in adults undergoing inguinal hernia surgery. After surgery, participants will receive physician-supervised TENS or usual care. Pain intensity and sleep quality will be measured and compared between groups to assess the effectiveness and safety of TENS as a supportive recovery method.

Introduction: Body mass index (BMI) is a key parameter used for obesity classification and the evaluation and monitoring of individuals' health status. Obesity, described by the World Health Organization as a major global epidemic, remains one of the most significant preventable and manageable conditions contributing to increased risks of cardiovascular and metabolic diseases. In addition to BMI, anthropometric measurements such as the waist-to-hip ratio are crucial indicators for risk assessment. While numerous studies in the literature have addressed the detrimental effects of obesity on respiratory functions, no study has specifically examined the relationship between cough strength-a vital respiratory parameter that reflects expiratory muscle strength- and body composition, waist-to-hip ratio, and peripheral muscle strength. Furthermore, although several studies have investigated the association between grip strength-a recognized indicator of peripheral muscle function in healthy individuals-and cough strength, no research to date has explored the relationship between pinch grip strength and cough strength. Objective: This study aims to investigate the relationships among body composition, waist-to-hip ratio, peripheral muscle strength, and cough strength in healthy young adults. Methods: This study was designed as a cross-sectional analysis. After providing detailed information about the study to potential participants, written informed consent will be obtained in duplicate from those who agree to participate. Following the completion of a general assessment form that captures demographic characteristics, each participant's height will be measured using a measuring tape. Body composition parameters-including body weight, BMI, body fat percentage, total body water percentage, muscle mass, basal metabolic rate, and metabolic age-will be assessed using a bioelectrical impedance analysis device (Tanita) available at our faculty. Waist and hip circumferences will be measured and used to calculate the waist-to-hip ratio for each participant. Peripheral muscle strength will be assessed using a hydraulic hand dynamometer and a pinch meter, while cough strength will be evaluated using a peak cough expiratory flow meter (PEF meter). All measurements will be repeated three times, with the best result recorded for analysis. Results: Statistical analysis will be performed using IBM SPSS Statistics version 30 (SPSS Inc., Chicago, IL, USA). Normality of continuous variables will be assessed through normality tests, coefficient of variation, and graphical representations (e.g., histograms, detrended plots). Descriptive statistics will be presented as mean ± standard deviation for normally distributed variables, and as median and interquartile range for non-normally distributed variables. Categorical variables will be expressed as percentages (%). Pearson correlation analysis will be used for normally distributed variables, and Spearman correlation analysis for non-normally distributed ones. The appropriate correlation coefficients and p-values will be reported. A p-value of \<0.05 will be considered statistically significant. Discussion: Interpretation will be based on the results of the statistical analyses.

This study is designed to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) can improve recovery for patients undergoing laparoscopic gallbladder removal surgery (laparoscopic cholecystectomy). TENS is a non-invasive method that uses mild electrical currents applied through the skin to stimulate nerves. The main goals of the study are to determine if TENS can: Reduce surgical anxiety before and during the procedure Decrease postoperative pain after surgery Improve overall patient satisfaction with their surgical experience Patients who participate will receive standard surgical care, and some will also receive TENS therapy. Outcomes will be measured using patient questionnaires and clinical assessments during the hospital stay and follow-up period. By comparing patients who receive TENS with those who do not, the study aims to provide evidence on whether this simple technique can enhance comfort and recovery after gallbladder surgery.

Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and psychological symptoms. Autonomic nervous system (ANS) dysfunction, marked by increased sympathetic and reduced parasympathetic activity, is considered one of its possible mechanisms. Although exercise is recommended in treatment, low motivation and fatigue often limit participation. Therefore, inspiratory muscle training (IMT), which targets the respiratory muscles, is seen as an easy-to-apply alternative.This randomized, controlled, double-blind study will be conducted at Niğde Ömer Halisdemir University Hospital. Fifty-one women aged 18-65 years who meet the 2010/2016 ACR criteria for fibromyalgia will be randomly assigned to three groups: training (30% of maximal inspiratory pressure), sham (0-10%), and control (no training). ANS functions will be assessed using heart rate variability and the COMPASS-31 questionnaire. Pain, sleep quality, fatigue, anxiety, depression, and respiratory muscle strength will also be evaluated. Training will be performed with the Powerbreathe® device twice daily for six weeks.The study aims to investigate the effects of IMT on ANS functions in fibromyalgia and to explore its relationship with symptoms such as pain, fatigue, sleep disturbances, anxiety, and depression.

The aim of the study; to determine the effect of the education program given to individuals diagnosed with asthma based on Roy's adjustment model on their psychosocial adjustment to the disease and their quality of life.

This study was planned to evaluate the effect of early mobilization training given to patients undergoing cesarean section in the preoperative period and targeted mobilization program applied after the surgery, on preventing gastrointestinal complications that may develop after the surgical intervention and participating in breastfeeding and baby care. The research will be conducted in experimental design. The research will begin after receiving written permission from Niğde Ömer Halisdemir University Ethics Committee, Niğde Provincial Health Directorate and Ömer Halisdemir Training and Research Hospital. Pregnant women who are between the ages of 18-35, who are at least a primary school graduate, who gave birth at term, who have a live singleton pregnancy, and who do not have a risky pregnancy history (DVT, thromboembolism) will be included in the study. Before starting the research, the study will begin by obtaining institutional permissions and written permission from the pregnant women. Personal Information Form prepared in line with the literature, postoperative gastrointestinal functions information form, postoperative abdominal distension diagnosis form, walking chart, VAS, LATCH Breastfeeding Diagnosis and Evaluation Scale and Breastfeeding Information Form data collection forms will be used to collect data. The data will be evaluated on a computer using the IBM SPSS Statistics 24 (Statistical Package for the Social Sciences for Windows) package program. Appropriate statistical analyzes will be used to evaluate the data

This study aims to determine the effects of kinesiology taping applied to operating room nurses on lower back pain, fatigue, and sleep quality. The research will be conducted using a randomized controlled experimental design with pre-test and post-test control groups. The universe of the study will consist of 100 operating room nurses working in a university hospital. The sample size has been calculated as a total of 84 nurses (Intervention group: 42; Control group: 42) based on power analysis calculations. The study will commence after obtaining the necessary permissions. Data collection will involve the use of the Descriptive Information Form, Visual Analog Scale, Quebec Back Pain Disability Scale, Visual Analogue Scale for Fatigue, and the Richards-Campbell Sleep Questionnaire. Participants who consent to the study will be administered the Descriptive Information Form, Visual Analog Scale, Quebec Back Pain Disability Scale, Visual Analogue Scale for Fatigue, and Richards-Campbell Sleep Questionnaire before the application of kinesiology tape. Subsequently, a physiotherapist from the research team will apply kinesiology tape to the paravertebral muscles using the muscle technique. As the literature suggests that the most suitable number of days for kinesiology tape application is four, participants will be instructed not to remove the tapes for four days. Additionally, participants will be informed that they can continue their daily activities and shower with the kinesiology tape on. The Visual Analog Scale will be applied to the participants at the end of the workday on the day of the kinesiology tape application and at the end of the workday for four days. At the end of the fourth day, all data collection tools will be applied. Seven days after the application, the scales will be filled out again by the nurses to determine if the effects of the kinesiology tape persist. Participants in the control group who agree to participate in the study will have data collected at the same time intervals as the intervention group participants using the same data collection tools. The Visual Analogue Scale will be administered to participants at the end of the day the data collection tools are filled out and at the end of the workday for four consecutive days. At the end of the fourth day, all data collection tools will be applied again. Seven days after the application, all scales will be refilled by the nurses..

This study was planned to determine the effect of information and progressive relaxation exercises before planned cesarean section on surgical fear, anxiety, postpartum comfort and pain levels.The research will be conducted in experimental design. The research will begin after receiving written permission from Niğde Ömer Halisdemir University Ethics Committee, Niğde Provincial Health Directorate and Ömer Halisdemir Training and Research Hospital. Pregnant women who are between the ages of 18-35, who are on Primigravida, who apply for a planned cesarean section, who have a live single pregnancy, and who are planned for spinal anesthesia will be included in the study. Before starting the research, the study will begin by obtaining institutional permissions and written permission from the pregnant women. Pre-Assessment Form, Personal Information Form, State Anxiety Scale, Surgical Fear Scale, Postpartum Comfort Scale will be used to collect data. The data will be evaluated on a computer using the IBM SPSS Statistics 24 (Statistical Package for the Social Sciences for Windows) package program. Appropriate statistical analyzes will be used to evaluate the data.

When the literature was reviewed, there is no study in which the effects of intermittent fasting and Mediterranean diet on quality of life, sleep, circadian rhythm and appetite hormones leptin and ghrelin levels in MS patients were evaluated and the two diet types were comparatively examined in terms of all these parameters.