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Showing 1-20 of 22 trials
NCT07544498
This study investigates the effectiveness of an extended reality (XR) based resilience training program designed to support the mental health and well-being of nurses working in hospital settings. Nurses are exposed to high emotional, cognitive, and organizational demands and show elevated levels of work-related stress and stress-associated mental health problems. Strengthening resilience and coping capacities is therefore an important preventive approach to support nurses' well-being and sustain quality of care. The study is conducted as a pragmatic randomized controlled trial with a waitlist control group and includes approximately 232 nurses from hospitals in several European countries. Participants are randomly assigned either to an XR-based resilience training group or to a waitlist control group that continues with care as usual during the waiting period. The XR-based intervention consists of eight immersive training sessions delivered over approximately ten weeks using a head-mounted display. The training focuses on behavioral, cognitive, and emotional coping strategies and aims to enhance key resilience factors such as problem-solving, cognitive reappraisal, emotion regulation, and positive self-care. The primary outcome is perceived stress, assessed using the Perceived Stress Scale. Secondary outcomes include resilience, occupational self-efficacy, quality of life, psychological distress, burnout symptoms, coping strategies, work-related rumination, and turnover intentions. Assessments are conducted at baseline, post-intervention, and at a 20-week follow-up. In addition, a subgroup of participants will optionally provide physiological data during selected XR sessions to explore digital biomarkers related to stress and recovery. The findings of this study will provide evidence on the effectiveness, feasibility, and acceptance of XR-based resilience training for nurses and inform future implementation of digital mental health interventions in healthcare workplaces.
NCT07465809
This interventional study evaluates the effectiveness of two 10-week self-regulation training programs (coaching-based and mindfulness-based) designed to enhance mental health and employability resources among healthcare workers (HCWs). Participants are allocated into two intervention arms based on their baseline level of emotional self-regulation. The study applies a non-randomized controlled pre-test/post-test design. The primary outcome is change in employability. Secondary outcomes include mental health indicators, such as perceived stress, anxiety, depressive symptoms and self-regulation. A follow-up assessment was conducted six weeks after the post-test. Additionally, qualitative semi-structured interviews were conducted to explore participants' subjective experiences with the interventions.
NCT07356141
* This study will enroll 10 dental students (primary subjects) and up to 200 patients (secondary subjects), approximately 10 special-needs and 10 non-special-needs encounters per student, totaling about 200 treatment sessions. * Students will wear an Apple Watch to continuously monitor heart rate (HR) during routine care. The Apple Watch contains built-in physiological sensors that automatically record heart rate and heart rate variability. These data are stored locally in the Apple Health app on a study-designated iPhone that is assigned for the research and handled solely by the Principal Investigator (PI). No real-time transmission or cloud-based sharing occurs during data recording. No additional apps, accounts, or third-party software are used. At designated intervals, the PI will use the health app's built-in "Export Health Data" function on the study iPhone. This function generates a ZIP file containing an export.xml file with sensor-recorded data. The PI will then upload the ZIP file from the study iPhone directly to a secure, university-approved UI Box Health Data Folder designated for the study. No research account will be set up for this purpose. * A trained observer will record start/stop timepoints of procedure phases (e.g., seating, anesthesia start, operative phase, dismissal) to align with HR signals and will document only minimal patient variables needed for analysis: behavior/cooperation score (e.g., Frankl), sedation status, and broad procedure category (e.g., preventive, restorative, surgical). * Each dental student will complete the Perceived Stress Questionnaire (PSQ) only once at the beginning of the study to stablish a baseline measure of stress. The Questionnaire takes approximately 5 minutes to complete. Students do not need to complete the PSQ for each patient encounter. Student HR data and permitted minimal patient variables will be coded and de-identified, stored securely in UI Box Health Data Folder, and analyzed to compare special-needs vs non-special-needs encounters and to evaluate associations between student HR and the listed patient factors. No additional patient identifiers or PHI will be collected beyond what is specified above.
NCT07380685
Clinical nurses are frequently exposed to high emotional demands due to heavy workloads, time pressure, patient suffering, and the interpersonal complexity of clinical care. These stressors may contribute to compassion fatigue, burnout, reduced resilience, and decreased occupational well-being. However, timely and accessible psychological support is often limited in busy clinical environments, and many nurses may hesitate to seek help due to stigma, time constraints, or limited resources. This study is a prospective, randomized, controlled, parallel-group interventional trial designed to evaluate the feasibility and effectiveness of an on-demand, human-centered emotional support intervention delivered through a LINE-based GPT assistant. The AI assistant provides real-time supportive conversations, reflective prompts, stress-coping guidance, and resilience-enhancing strategies tailored specifically for clinical nurses, offering a private and easily accessible support resource. Eligible clinical nurses (target sample size: 100-120) are randomly assigned to either an Intervention Group, which interacts with the AI assistant, or a Control Group, which receives non-interactive static messages, over a four-week intervention period. Primary outcomes include changes in compassion fatigue, burnout, and compassion satisfaction, as measured by the Professional Quality of Life Scale (ProQOL). Secondary outcomes include changes in resilience (Brief Resilience Scale), general self-efficacy (General Self-Efficacy Scale), and perceived stress (Perceived Stress Scale-10). The results of this study are expected to provide evidence on the feasibility and potential effectiveness of AI-based emotional support as a scalable and accessible tool to promote psychological well-being among clinical nurses, thereby informing future digital mental health interventions in healthcare settings.
NCT04785677
The investigators are conducting a randomized controlled trial to assess the impact of Resiliency in Stressful Experiences (RISE) - a comprehensive trauma-based program for young men releasing from a southeastern state's prisons. The investigators are assessing whether treating trauma and providing other transitional supports - such as employment assistance - as young men return home will help to improve their community stability and enhance their psychological well-being, in turn, resulting in less likelihood that a person will become incarcerated in the future.
NCT07411833
The goal of this clinical trial is to evaluate if transcranial direct current stimulation (tDCS) works to reduce occupational stress and burnout in university professors. The main questions it aims to answer are: Does tDCS reduce levels of occupational stress in university professors? Does tDCS reduce burnout levels in university professors? Researchers will compare active tDCS to a sham stimulation (a look-alike procedure that contains no active stimulation) and a control group to see if tDCS effectively reduces stress and burnout. Participants will: * Complete questionnaires assessing stress and burnout levels before the intervention * Complete follow-up assessments immediately after the intervention and 5 weeks later During intervention, participans of active tDCS and Sham gruops will: * Receive 10 sessions of tDCS over 4 weeks (excluding weekends), 20 minutes each
NCT07416071
This study aimed to examine the effect of mandala therapy on psychological well-being and organizational cynicism levels among nurses. The study was conducted with nurses working in a public training and research hospital using an experimental intervention design. Participants were allocated to an intervention group receiving mandala therapy and a control group receiving routine working conditions. Psychological well-being and organizational cynicism were assessed before and after the intervention using validated measurement tools.
NCT07403656
Emergency nurses are frequently exposed to both traumatic events and routine work-related stressors due to the nature of emergency care settings. These experiences may have important emotional and psychological effects, which can influence nurses' well-being, job satisfaction, and quality of patient care. The aim of this study is to examine the frequency and emotional impact of traumatic and routine stressors experienced by emergency department nurses during the past six months. The study focuses on identifying common stressors and understanding how often these events occur and how strongly they affect nurses emotionally. This observational, cross-sectional study was conducted among emergency nurses working in public hospitals in Turkey. Data were collected using a structured questionnaire that includes demographic questions and the Traumatic and Routine Stressors Scale (TRSS-TR), a validated instrument designed specifically for emergency nurses. The findings of this study are expected to contribute to a better understanding of occupational stress among emergency nurses and to support the development of strategies aimed at protecting nurses' mental health and improving working conditions in emergency care environments.
NCT04166643
The goal of this proposed study is to test the feasibility and preliminary efficacy of worksite wellness program designed to reduce worker stress (job and personal) and improve cardiovascular disease among long-term care workers. We also aim to test if increasing wellness behaviors in staff will translate to increased wellness behaviors in residents due to positive role modeling.
NCT07111026
The goal of this hybrid Type 1 effectiveness-implementation trial is to test the extent to which a peer support and community resource navigation intervention improves psychological well-being, addresses social determinants of health and thus reduces cardiometabolic risk among rural, migrant, low-income farmworker women aged 18-45 years. The main questions it aims to answer are: * If and to what extent does the intervention reduce stress, social isolation, and psychological distress by improving social support and access to needed resources? * If and to what extent does the intervention improve cardiometabolic health, measured by the American Heart Association's Life's Essential 8 (LE8) score? Researchers will compare the CHW-led Sisters of Heart (Hermanas de Corazón) intervention to a Basic intervention (LE8 assessment and resource information) to assess the effect of peer support and community resource navigation on heart health outcomes.
NCT07188831
Hospital staff often experience workplace fatigue and poor sleep quality, which can harm their health, reduce job performance, and increase risks to patient safety. Aromatherapy is a simple, non-invasive complementary therapy that may help reduce fatigue and improve sleep. Agarwood (Aquilaria spp.) has calming and relaxing properties, but there is little clinical research on its effectiveness for hospital staff. This randomized, double-blind, controlled trial will evaluate whether agarwood aromatherapy inhalation can improve fatigue and sleep quality among hospital employees in Taiwan. About 78 participants will be recruited and randomly assigned to one of two groups: 1. Experimental group: Agarwood sachet containing agarwood wood chips and essential oil. 2. Control group: Placebo sachet containing almond oil. Participants will place the sachet about 60 cm from the nose during sleep for 7 nights. Data will be collected using questionnaires on workplace fatigue and sleep quality (Pittsburgh Sleep Quality Index, PSQI). The main questions this study aims to answer are: 1. Does agarwood aromatherapy reduce workplace fatigue in hospital staff? 2. Does agarwood aromatherapy improve sleep quality compared with placebo? Findings are expected to provide scientific evidence for using agarwood inhalation as a safe and convenient strategy to improve staff well-being and support a healthier hospital environment.
NCT06888297
The "second victim" phenomenon affects healthcare professionals who experience highly stressful events in their daily practice, potentially compromising their well-being and patient safety. Despite the need for structured support interventions, many European institutions lack formal programs to address this issue. The RESCUE project responds to this need, building on the previous work of the ERNST Consortium (COST Action 19113). Its objective is to develop and validate two certification systems: one for second victim support interventions and another for training healthcare professionals as peer supporters. A mixed-methods approach will be used, incorporating expert consensus techniques (e.g., Delphi study and consensus conferences) and pilot studies in healthcare institutions across multiple European countries. The study aims to establish European certification standards for second victim support interventions, improving support for healthcare professionals, increasing resilience, and reducing the impact of adverse events on clinical performance.
NCT06998602
This study explored how student paramedics experience compassion fatigue - a type of emotional and physical exhaustion that can occur when regularly caring for others in distress. The researchers wanted to understand how student paramedics feel about compassion fatigue, how it affects their work, and what kind of support might help them cope. To do this, a group of student paramedics were interviewed about their personal experiences and also asked to complete a short questionnaire called the Professional Quality of Life Scale (ProQOL). This questionnaire measured their levels of compassion satisfaction (positive feelings from helping others), burnout (emotional exhaustion), and secondary traumatic stress (stress from exposure to others' trauma).
NCT05791461
The goal of this realist evaluation of a Danish Cognitive Behavioral Therapy (CBT)-based stress management for patients with work-related stress is to understand what works, for whom, in what circumstances.The main objectives are: To assess the effect of the stress management intervention on sustainable return to work. To investigate what contexts and mechanisms are associated with patients' return to work rates and level of perceived stress after having received the stress management intervention. To understand from a patient perspective how mechanisms work in specific contexts to generate effects of the stress management intervention. The evaluation comprises two observational studies and one interview study. The intervention cohort are patients with work-related stress who received the stress management intervention between 2012-2018. The comparison cohort are patients who would have been eligible to receive the intervention in 2011-2012, however they did not receive any intervention because it was not offered at that time. In study one return to work rates are compared between the intervention cohort and the comparison cohort to find out if the intervention can help patients return to work at a faster rate. Study two will investigate if there are any explanatory variables (such as work type, civil status or level of depressive symptoms) that may explain why some patients benefit more or less from the intervention. Study three will explore what it is about the intervention (mechanisms) the patients find are helping them to cope with stress or the opposite in specific circumstances.
NCT05871411
We spend a third of our life at work. Psychosocial risks (PSR) are a major issue in occupational health 1. Approaching the different dimensions of PSR calls on a dozen essential components: workload, autonomy, social support, burnout, anxiety, efforts made, rewards, work addiction, investment, etc. a specific questionnaire which usually contains 20 to 30 questions, so that having an overall view of PSR using the current reference questionnaires (Karasek, Siegrist, etc.) represents a total of more than 300 questions. The response time is thus incompatible with current medical practice (passage in the waiting room before the occupational health medical examination) and leads to a majority of non-responses during anonymous questionnaires on the Internet. On the other hand, these validated questionnaires were carried out by different people and are very heterogeneous between them, including in their formulation, so that the respondents have the impression of disorganization and anarchy. There is therefore a need for short, quick and uniform questionnaires. EVAs offer the incredible advantage of meeting these criteria: speed, uniformity, precision. From a data analysis point of view, EVAs also have the advantage of offering a continuous quantitative response, allowing the use of all statistical approaches. If some questionnaires have already been validated in the form of EVA, such as the EVA stress versus the " Perceived Stress Scale " questionnaire (PSS), the EVA workload and EVA autonomy at work versus the Karasek questionnaire, the other reference questionnaires are not yet validated in EVA (burnout, anxiety, efforts / rewards, work addiction, etc.).
NCT05154019
This feasibility pilot cluster RCT aims to pilot and feasibility test an online training toolkit (Managing Minds at Work) for line managers to develop their knowledge and confidence in preventing work-related stress and promoting mental health at work. The setting is work organisations of different types and sectors across the Midlands region of the United Kingdom. Participants must have direct managerial or supervisor responsibilities for 3 or more staff members. The intervention consists of five modules of online learning: Looking after your own Mental Health; Designing and managing work to promote mental well-being; Management competencies to prevent work-related stress; Developing a psychologically safe work environment; Having conversations about mental health at work. Each module includes some descriptive content, interactive elements and opportunities for reflections, and take between 20-30 minutes to complete. Participating organisations will be allocated to either the intervention or control arm. A waiting list control will be used, with line managers in the control organisations starting the intervention 3-months after baseline. Data will be collected through online surveys with the intervention group at baseline, immediately post-intervention (around 6 weeks post baseline), 3-months follow-up and 6-months follow-up. Control group will complete the online surveys at baseline and 3-months (as they start the intervention) and immediately after completing the intervention. As a feasibility pilot study, analysis will be focused on acceptability of the intervention, feasibility of recruitment, retention and data collection, and estimating parameters for a larger trial. The primary outcome measure is line managers' confidence to create a mentally healthy workplace. The secondary outcomes line manger mental health knowledge, line manager workplace mental health literacy, line manager self-rating of behaviour. In addition, the direct reports of line managers will be invited to participate to assess the feasibility of collecting the outcome data related to: employee well-being, employee rating of line manager behaviour, employee sickness absence, employee productivity. A process evaluation will be conducted to assess intervention acceptability, usability, implementation and effectiveness. Qualitative data will be collected via module feedback forms and in-depth interviews with a sample of line managers from the intervention arm and stakeholders.
NCT05974735
Participants will be selected according to their affiliation with the Paris 8 CPTS. They will be asked to complete a series of self-questionnaires to determine their stress levels and lifestyle habits. These tests will be used to define a wellness pathway for each participant in order to reduce the stress they feel at work. These wellness pathways are based around 4 distinct themes: * Diet, nutrition and micronutrition * Physical activity * Sleep * Stress and wellness. Participants will be follow-up at 3 and 6 months by means of self-questionnaires and advice on the programme.
NCT05608889
Conduct a quasi-experimental pre-post study of a mindfulness-enhanced, web/app-enabled, scalable Total Worker Health (TWH) program among higher stress Corrections Professionals. The primary outcomes relate to behaviors promoted by the program: being mindful/reduced stress/improved mood; healthier eating; more physical activity; greater restorative sleep; improved work-life balance and greater positive feelings about the organization.
NCT04948255
This prospective cohort study was designed to assess WRS amongst clinical and non-clinical staff in a primary healthcare setting using a validated tool with a view to developing an evidence base to form a historical and comparative record during the Covid-19 pandemic.
NCT04365335
This study is aiming at investigating whether professional burnout in people involved in the mobile intensive care unit (in French: Element Mobile de Réanimation, EMR) in Mulhouse (France) can be predicted upstream by a low mindfulness level (as a protective factor) or by a dysregulation of stress pathways with a high level of perceived stress towards an emotional event (psychological index of allostatic load), i.e. an early and silent dysfunctional physiological response (measured by the electrophysiological and biological measurements of allostasis load and parasympathetic brake). It is part of a global approach aiming at identifying levers to prevent the allostatic load of occupational stress related to large-scale health crises.