Clinical Research Directory

Acute Effects of LLLT on Pain Threshold and Pain Tolerance

Pain is defined by the International Association for the Study of Pain as "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage." Low-Level Laser Therapy (LLLT) has gained attention as a safe, noninvasive intervention with analgesic and anti-inflammatory effects. This study examines whether a single session of LLLT can produce immediate changes in pain threshold and pain tolerance in healthy adults, compared to a sham laser control.

Correlation Between Pain Threshold and Analgesic Consumption in Transvaginal Oocyte Aspiration Patients

Nowadays, in vitro fertilization (IVF) is an important component of modern infertility treatment. One of the critical stages of the IVF process is oocyte (egg) retrieval, which requires both anesthesia and analgesia; this directly affects the comfort of the participants and the success of the procedure. Since its first implementation, various methods and techniques have been used for oocyte retrieval, and today it is most commonly performed under anesthesia with transvaginal ultrasonography guidance. Because this procedure is performed on an outpatient basis in IVF centers worldwide, the anesthetic agents used are expected to meet several essential criteria: they should have a short half-life, a rapid onset of action, and minimal, acceptable side effects. In addition, these agents should not adversely affect participants' recovery processes. While the agents used determine the quality of sedation and analgesia, concerns persist regarding their potential negative effects on reproductive outcomes. Considering that participants often experience high levels of anxiety, effective pain management must be ensured during the procedure. Moreover, participants must remain immobile throughout the procedure. To achieve this, general anesthesia, regional/local anesthesia, neuraxial anesthesia, patient-controlled analgesia, sedation, acupuncture, or combinations of these methods may be used. Conscious sedation is the most commonly applied anesthesia method for women undergoing transvaginal oocyte aspiration. This method is preferred by approximately 95% of IVF centers in the USA and 84% in the UK. Conscious sedation allows the participant to maintain airway control and adequate oxygenation independently, while also providing a reduction in consciousness. Currently, midazolam, propofol, and fentanyl are the most frequently preferred agents for this purpose. They are easy to administer and are safe for cooperative participants. Compared to other anesthetic agents, they have relatively lower negative effects on oocyte and embryo quality and fewer adverse impacts on pregnancy rates. However, studies have shown that midazolam, fentanyl, and alfentanil can be detected in follicular fluid even after a single dose. In vitro studies on mouse oocytes and some human studies have indicated that propofol may have dose-dependent harmful effects on fertilization. Therefore, some researchers recommend that propofol should be used with caution during oocyte retrieval, with attention to limiting the total dose administered. As prolonged exposure to anesthetic agents has been shown to negatively affect fertilization, it is recommended that oocytes be exposed to anesthetic agents at the lowest possible level. Thus, for successful outcomes, it is critical that the anesthetic agents used during transvaginal follicle aspiration be administered at appropriate doses and durations. The researchers aim in this study to examine the correlation between the amount of anesthetic agent required and the pain threshold in participants whose pain thresholds are measured and who receive patient-controlled analgesia combined with conscious sedation. As a secondary objective, the researchers aim to compare participants' demographic characteristics, sociocultural status, stress and anxiety levels, the amount of anesthetic agent used, and its hemodynamic effects. This study is designed as a prospective, open-label, single-arm, non-randomized study. Forty female participants aged 18-50 years who will undergo oocyte retrieval for IVF treatment at the Erciyes University Department of Obstetrics and Gynecology will be included. To assess participants' pre-procedural stress and anxiety levels, the Spielberger State-Trait Anxiety Inventory (STAI) will be administered. Each participant's pain threshold will be measured at three sites-one muscle area (deltoid) and two bony areas (thumb and mid-tibia)-using an algometer (Commander Echo Algometer, JTECH Medical, Midvale, UT, USA), with bilateral measurements taken once at each site. The average of these three measurements will be calculated to determine the overall body pressure pain threshold for each participant. Prior to the procedure, all participants will receive 1.5 mg midazolam IV. During conscious sedation, a pre-prepared solution of 15 cc 1% propofol (150 mg) and 5 cc fentanyl (250 mcg) in a total volume of 20 cc will be administered using a PCA device with no lockout interval. Participants will be instructed to press the PCA button whenever they begin to feel pain. Hemodynamic parameters (systolic, diastolic, and mean arterial pressure, heart rate, SpO₂), Ramsay Sedation Scale (RSS) and Facial Score (FS) values will be recorded throughout the procedure. After the procedure, participants will be closely monitored for nausea, vomiting, and respiratory depression. In addition, total follicle count, embryo count, and pregnancy status will be recorded

Perception of Pain During Gender Affirming Hormone Therapy

It is known from the literature that women and men differ in their perception of pain. Why this is the case has not been conclusively clarified. Sex hormones could have a significant influence on this. The study team suspects that the classic hormone status of women is responsible for the lower pain threshold compared to men. People undergoing gender affirming therapy receive biologically opposite-sex hormones in order to adapt their external appearance as well as their voice, emotional life etc. to the desired gender. The aim of this study is to longitudinally record whether the intake of opposite-sex sex hormones leads to a change in pain and perception thresholds in this patient collective. To this end, potential study participants will be informed about the study and asked whether they would like to participate before the start of hormone therapy during their first visit to the transgender outpatient clinic. If consent is given, a questionnaire on mental health (PHQ 9), a blood sample to determine the hormone status and the first QST (quantitative sensory testing) measurement are then carried out. The second measurement with blood sampling takes place 3-4 weeks after the first measurement. The 3rd and 4th measurements with blood sampling are taken 3 and 6 months respectively after the first measurement. The PHQ 9 is measured again at the time of the last measurement. Study participation ends after a total of 6 months. The blood samples, the PHQ 9 and the QST measurements have no influence on the treatment of the study participants.

ACU_Knee: Role of Acupuncture in Knee Prosthetic Surgery

Post-operative analgesia after total knee arthroplasty (TKA) has always been a challenge in the anesthesiological setting, having to combine good pain control and the need for early mobilization, both factors that can affect the quality of rehabilitation treatment, prosthetic functional outcome, the onset of chronic pain, joint stiffness and the consequent quality of life of the patient. Recent loco-regional anesthesia (LRA) techniques have made an essential contribution to peri-operative management in the fast-track perspective of surgery, in terms of optimization of analgesia and rapid functional recovery. Inadequate post-operative analgesia, by affecting the normal rehabilitation pathway, is associated with medium-long term complications, such as chronic pain, joint stiffness and patient dissatisfaction, which often compromise functional autonomy and quality of life of the patient and may require invasive treatments (surgical revision, unlocking under general anesthesia). The local and systemic inflammatory state, evidenced by peri-operative dosage of specific biomarkers, appears to be related to prosthetic outcome.

A Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder

This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain thresholds, anxiety, depression, and sleep.

HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children

Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior. Physically active pregnant women significantly less often suffer from, among others, gestational diabetes, excessive weight gain, lipids disorders, hypertension, preeclampsia, depressive symptoms, functional and structural disorders, including stress urinary incontinence, back pain or diastasis recti abdominis (DRA). Prenatal physical activity reduces the risk of premature delivery and miscarriage, fetal macrosomia, complications in labor or the risk of metabolic disorders in children. High-intensity interval training (HIIT) has become one of the most popular trends in the fitness sector. The effectiveness of HIIT on a number of health indicators has been proven in various populations but limited data are available on HIIT during pregnancy. The first hypothesis is that the HIIT, implemented during pregnancy and after childbirth, as a stronger exercise stimulus, will have a better impact on selected biological and psychological parameters of mothers, as well as on selected health parameters of their children, compared to the MICT (moderate intensity continuous training). Therefore, it promises better preventive effects on pregnancy complications and ailments as well as non-communicable diseases occurring in these populations. In the second hypothesis, it was assumed that HIIT and MICT implemented during pregnancy and after childbirth, tailored to the specific needs of the perinatal period, will not differ in the effectiveness of maintaining normal functional parameters in women, including prevention of urinary incontinence, back pain, DRA, etc. Pregnant women who apply for the study will be divided into three groups: those attending the HIIT, MICT or educational programs. During the study, the participants will be under standard obstetric care. As comparative groups, non-pregnant women will be also recruited. The investigators will collect data on selected biological, functional and psychological parameters in the study women at each trimester of pregnancy, during the puerperium and one year after childbirth. The data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in the study women's children aged one, two, four and six years will be also analyzed.