Clinical trials

Public Speaking Anxiety (PSA) is a common manifestation of social anxiety among university students that can negatively impact academic performance and psychological well-being. Virtual Reality (VR) based interventions combined with Cognitive Behavioral Therapy (CBT) represent a promising approach to address PSA by enabling controlled, gradual exposure to feared social situations through realistic simulations of audiences and settings. This randomized controlled trial will evaluate whether integrating VR sessions into standard psychological counseling provided by the University Psychological Counseling Service (UPCS) improves anxiety and PSA outcomes in university students compared with counseling alone. Participants will be randomized to one of two groups: (1) a control group receiving standard psychological counseling intervention, or (2) an experimental group receiving psychological counseling supplemented with VR interventions delivered via immersive 360° video scenarios. The VR-based intervention includes a VR-Exposure and Response Prevention (ERP) module offering graded exposure to anxiety-provoking public speaking contexts, and a VR-Acceptance and Commitment Training (ACT) module aimed at enhancing mindfulness and psychological flexibility through guided experiential exercises. Psychological outcomes and physiological responses recorded during sessions will be analyzed to compare the effectiveness of VR-integrated counseling versus standard counseling alone. This study addresses the limited evidence on CBT combined with 360° video-based VR exposure for PSA in university students and introduces a novel VR-based ERP and ACT protocol tailored to a university counseling setting.

Infections associated with cardiovascular implantable electronic devices (CIEDs) represent one of the major postoperative complications in interventional cardiology. These infections-including lead-related endocarditis, subcutaneous pocket infections, and sepsis-are characterized by high rates of morbidity, mortality, and healthcare costs. According to current epidemiological data, the incidence of CIED-related infections is estimated to be around 0.5-2% within the first 12 months and may rise to 5% over long-term follow-up. These infections are associated with a mortality rate of up to 34% and often require device explantation and prolonged antibiotic therapy. TauroPace™ is an antimicrobial solution based on taurolidine, a broad-spectrum, non-antibiotic agent that acts by disrupting bacterial biofilms and preventing microbial colonization. Taurolidine has a favorable safety profile, does not induce antibiotic resistance, and is already approved in Europe as a CE-marked medical device (Directive 93/42/EEC). The application of TauroPace™ to the surface of CIEDs prior to implantation may significantly reduce the incidence of infections compared to the current standard, which consists of irrigating the device pocket with sterile saline solution. The aim of this study is to rigorously and systematically evaluate the effectiveness of TauroPace™ compared to standard clinical practice.

Pain during pacemaker or defibrillator implantation can increase patient discomfort, anxiety, and the need for deeper sedation. Using virtual reality (VR) as a non-pharmacological distraction tool may help reduce perceived pain, stabilize vital signs, and improve the overall patient experience. This prospective, single-center study evaluates whether adding VR to standard sedation lowers pain levels compared to sedation alone. Patients undergoing device implantation will be randomized to either group, with pain and vital signs monitored throughout the procedure. The study also explores patient satisfaction, adverse effects, and the potential of VR to support same-day discharge after minimally invasive procedures.

Sepsis is one of the leading causes of hospital mortality, with a rate of approximately 20% (World Health Organization) among vulnerable patients admitted to high-intensity care units such as CCUs and inpatient wards. Currently, diagnostic criteria such as the Systemic Inflammatory Response Syndrome (SIRS) and the Sequential Organ Failure Assessment (SOFA) score, although widely used, lack sufficient specificity and accuracy. No established parameters are available for early and timely diagnosis. This study aims to address this gap by investigating the variability of blood plasma conductivity and dielectric constant using microwave probes previously validated for non-invasive glucose monitoring. The acquired data will be analyzed using the Anritsu VectorStar VNA to identify innovative and reliable parameters associated with the presence of severe infections.

Left atrial cardiomyopathy (LACM) is frequently underdiagnosed but plays a key role in increasing the risk of atrial fibrillation (AF) and thromboembolic events. While atrial strain is a validated marker of LACM, its measurement with conventional echocardiography can be time-consuming and less feasible in acute settings. The use of AI-assisted echocardiography (AI-echo) may help streamline image acquisition and analysis, offering faster and potentially more accurate assessment. This study aims to compare the time required for atrial strain analysis using AI-echo versus standard methods. It also explores how changes in strain parameters (LASr, LASct, LAScd) relate to the onset of AF and in-hospital adverse outcomes, adjusting for comorbidities and conventional echo variables. Main endpoints include time reduction with AI-echo and the association between strain changes and AF, complications, or mortality during hospitalization.