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NCT07431372
Multi-professional primary care practices (Maisons de Santé Pluriprofessionnelles, MSP) have expanded widely in France over the last decade to respond to increasing healthcare needs, uneven distribution of physicians, and deteriorating working conditions, which were further exacerbated by the COVID-19 pandemic. MSPs are expected to offer more collaborative and coordinated care, and to provide a more attractive work environment, particularly for younger healthcare professionals seeking less isolation and better work-life balance. Well-being at work for healthcare professionals is now recognised as a key determinant of quality and safety of care. Studies have shown links between staff satisfaction, burnout, and patient outcomes, including communication quality, error rates and staff retention. However, research specifically focused on collective well-being or "shared happiness" within multi-professional primary care teams remains limited. Existing work in French MSPs (notably qualitative studies by F. Burté and O. Caillaud) has identified relevant dimensions of "shared happiness" and led to the preliminary construction of a questionnaire named the Shared Happiness Index (Indice de Bonheur Partagé, IBP). To date, no validated, standardised instrument exists to measure this collective well-being in MSPs. The Be\_aPi study aims to validate the IBP questionnaire among healthcare professionals working in MSPs. The study is observational, descriptive and cross-sectional, conducted in several French regions covered by the GIRCI (Groupement Interrégional de Recherche Clinique et Innovation) SOHO (Sud-Ouest Outre-Mer Hospitalier) network (Nouvelle-Aquitaine, Occitanie, Réunion and Mayotte). It comprises three main steps. First, a content validation phase will be carried out with two independent panels of experts. One panel, including psychometrics, methodology and linguistics experts and MSP representatives, will assess face validity by examining each item in relation to the concept of shared happiness in multi-professional primary care. A second panel will be involved in an e-Delphi process to establish consensus validity on the relevance and clarity of items, using Likert-type ratings and iterative feedback. Second, the psychometric validation phase will recruit approximately 350 professionals from over 100 MSPs. Eligible participants include medical and paramedical professionals, medical-social staff, medical assistants, coordinators, health mediators, adapted physical activity instructors and psychologists, working in MSPs that have been operating for at least one year, with at least one year of seniority in their current MSP. Participants will complete an online survey including the IBP questionnaire and three reference instruments: the Maslach Burnout Inventory (MBI), the General Health Questionnaire-12 (GHQ-12) and the Short Form-12 (SF-12). Internal consistency of the IBP will be assessed using Cronbach's alpha, and construct validity will be examined with exploratory factor analysis and correlation patterns with the reference scales, according to a multi-trait multi-method approach. Third, to evaluate test-retest reliability, participants who completed the initial IBP will be invited to fill in the same questionnaire again after a delay of approximately one month. The stability of scores over time will be assessed using intraclass correlation coefficients. Ceiling and floor effects, as well as the distribution of scores across professional categories and organisational characteristics of MSPs (e.g. single-site vs multi-site, role in the organisation, membership in interprofessional associations), will also be analysed. The expected outcome of Be\_aPi is a valid, reliable and transferable Shared Happiness Index specifically tailored to multi-professional primary care practices. This tool should enable regular monitoring of collective well-being, support targeted quality-of-work-life interventions, and ultimately contribute to improving quality and safety of care, staff retention and the long-term sustainability of MSPs. In the longer term, the IBP could inform policy instruments and financing schemes that aim to "take care of those who care," in line with national quality and safety strategies.
NCT07334769
This study aims to examine the effect of a newly developed religously oriented cognitive behavioral group therapy program on the level of anxiety and well-being in young adults compared to the traditional cognitive behavioral therapy-based program. Hypoteses 1 Religiously oriented CBT group therapy will be more effective in reducing participants' general anxiety levels compared to traditional CBT group therapy and the control group, and this effect will continue in the two-month follow-up measurements. Hypoteses 2 Religiously oriented CBT group therapy will be more effective in increasing participants' levels of well-being compared to traditional CBT group therapy and the control group, and this effect will continue in the two-month follow-up measurements.
NCT07301879
The Libellules (WB6Dim) study aims to validate a digital self-assessment tool for measuring individual well-being across six dimensions: sleep and recovery, emotional climate, self-esteem, perceived autonomy, energy reservoir, and hyperconnection. This observational study includes approximately 800 adult participants divided into two cohorts: one group completes the self-assessment tool only, while the other group additionally performs a brief video-based relaxation exercise during the 15-day interval between evaluations. Each participant completes the Libellules questionnaire and a set of validated gold-standard psychometric scales (including PSS-10, ISI-7, CFQ, SAS-SV, and PIUQ-9) at baseline and after 15 days. The primary objective is to evaluate the convergent validity, internal consistency, and test-retest reliability of the Libellules items compared with established instruments. The study is fully anonymous, non-interventional, and conducted in compliance with data protection regulations (CNIL, GDPR).
NCT05447312
The proposed study is a pilot study that aims to understand if the Pi Electronics adaptive music intervention (AM) is effective to promote positive psychosocial and cognitive outcomes, over and above a traditional music intervention (TM) among healthy older adults. This study will contribute to the ongoing literature on the benefits of music interventions and provide insight on how emerging technology can enhance the therapeutic effects of music as a viable intervention for older adults. The study will adopt a three-arm randomized controlled trial (RCT). Eligible participants will be randomized into one of three groups: traditional music therapy group (TM), Pi Electronic's adaptive music program (AM), and a waitlist control group (CG). Informed consent will be collected from all participants. All three groups will complete outcome measures at three sessions: pretest, posttest, and at a three-month follow-up, but only the TM and AM group will receive music between the pretest and posttest sessions, spanning for 4 weeks, with 4 music therapy sessions per week, and each session lasting 30 minutes. Data will be analyzed for each outcome variables to understand the group differences in the performance on the psychosocial and cognitive outcome measures. The study will also validate the Pi Electronics EEG headset with the BioSemi, 64-channel EEG system.
NCT06923436
The psychological well-being of healthcare workers in hospital settings is a topic of growing interest in the scientific literature, given the crucial importance of their role in ensuring high-quality care. In addition, the Covid-19 pandemic health emergency has further accentuated the relevance of this issue, increasing anxiety and stress levels, testing the resilience and resistance of those working in care settings, revealing and highlighting how the accumulation of work-related stress can result in disabling pathologies for the caregiver, with an inevitable impact on the facility and care in general. Recent studies show that health care workers are particularly vulnerable to work-related stress, which can result from various factors such as high work demands, emotional pressure, irregular shifts, and interactions with critically ill patients. Burnout syndrome, characterized by emotional exhaustion, depersonalization and reduced personal accomplishment, is widely documented among hospital staff. Research indicates that burnout not only compromises the psychological health of healthcare workers, but also negatively affects the quality of care provided by increasing the risk of medical errors. In light of these factors, it is crucial to deepen our understanding of the dynamics that influence psychological well-being and work-related stress in health care workers in order to develop effective interventions that can improve their quality of life and consequently the quality of care provided to patients. Preliminary assessment of the emotional burden and motivational aspects of health care workers (showing what very often eludes a first glance, making visible something that is often invisible), along with effective stress management, would allow for greater ability to remain calm under pressure, reduced frustration, increased ability to make informed decisions, and to communicate effectively with patients and colleagues. These aspects translate into an image of a safer and more caring health care system in promoting better quality of care. The aim of this project is to highlight the importance of psychological wellbeing for those working in health care settings and to promote attention to this area, also with a view to identifying possible interventions aimed at identifying preventive and protective factors in relation to health care workers. The aim, therefore, is to show what is very often invisible at first sight, to make visible what is invisible: to explore, accommodate and contain areas of criticality and fragility in the context of work in health care settings, working on interventions aimed at the psychological well-being of workers.
NCT06737744
Objective: The goal of this one-sample clinical trial is to implement active games, including physical activities, that support the social and emotional competencies of individuals in probation sentence. Methods: The study was carried out with 50 young adult offenders. The Collaborative for Academic, Social, and Emotional Learning (CASEL) model, which defines five social and emotional skills (self-awareness, self-management, responsible decision making, relationship skills, social awareness), was used to support observation and game design. The present study involved the codesign of a total of 18 active games to develop these five competencies. The primary outcomes of the research were increased mental well-being and increased social emotional skills in participants receiving the AG4C program. The secondary outcome of the research was the regular participation of the participants in the program. In this study, two hypotheses were tested: "The ActiveGames4Change programme increases the psychological wellbeing of young adults on probation" and "The ActiveGames4Change programme increases the 5 basic skills of young adults on probation. This study was carried out with 50 young adult offender individuals (48 male and 2 female) who received probation measures in accordance with the court or prosecutor's decision for different crimes. The CASEL model, which defines social and emotional skills, was used to support observation and game design because it determines the characteristics of young people who are in the execution process. The skill set proposed by the CASEL model included skills such as "self-awareness", "self-management", "social awareness", "relationship skills" and "responsible decision-making". The Wilcoxon signed-rank test was employed to examine the impact of the intervention on participants' progression of competency levels before and after the intervention.
NCT06648018
The primary aim of the current study is to evaluate the effects of dietary nutritional advice with regards to iron rich food sources or a daily oral supplement of 100 mg ferrous iron succinate in 80 menstruating, healthy women aged 20-40 years for 8 weeks. The study will use a randomized controlled non-blinded design, and 80 healthy women aged 20-40 years whom regularly exercise will be included. Data collection will be made through online, standardized forms using the digital platform REDCap 13.1.28 (Vanderbilt University, Nashville, TN, USA). Study personnel will register laboratory and body weight results through the same system. Participants will be randomized 1:1 to either follow written dietary recommendations to increase their dietary iron intake, or to use a daily oral supplement of 100 mg of iron succinate. Study parameters are blood tests (fasting blood samples will be collected by a licensed laboratory: serum iron, serum transferrin, serum transferrin saturation, serum ferritin, and serum soluble transferrin receptor, blood status (hemoglobin, MCV, MCH, MCHC, thrombocytes, leukocytes), and plasma high-sensitivity C-reactive protein (hsCRP) and Body height and weight as well as questionnaires.