Clinical trial NCT06923436: Survey of Psychological Well-being of Health Care Workers in the Hospital Setting
Official title: FROM THE INVISIBLE TO THE VISIBLE: Survey on the Psychological Well-being of Hospital Healthcare Workers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Healthy
Psychological Well Being
Stress Response
Professional Quality of Life
Resilience
Alexithymia
Spirituality
Coping Skills
Job-related Affective Well-being
Burnout, Healthcare Workers
Empathy Skills
Quality of Life Outcomes
Technostress
Keywords: Psychological well-being of health care workers in the hospital setting
work-related stress
emotional burden
Motivational aspects of health professionals
occupational well-being
Perceived Stress
Perceived stress from the intensive use of digital technology in work settings
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthcare workers, with a focus on contexts and departments considered more critical (due to the type of activity or the type of patients, such as the emergency area or oncology departments).

Brief summary: 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.

Detailed description: this work aims to recognise and legitimise the potential stressors of those who work in the health sector, with a focus on the most critical departments in terms of patient type and intervention, aware of the need to explore emotional experiences and professional needs from a prevention and protection perspective, in order to design effective interventions that promote the protection of operators' psychological well-being and strengthen their resilience factors. Drug-free, device-free, single-center, prospective longitudinal observational study with a total duration of 18 months.

Primary Objective: To record and describe over time some psychological dimensions related to the work activity of FPG workers, with a focus on contexts and departments considered more critical (for the type of activity or type of patients, such as the emergency area or oncology wards), in order to highlight possible areas of improvement and with respect to psychological well-being and Quality of Life (QoL) in the professional setting.

Secondary Objectives:

* Improving coping strategies, enhancing resilience, assessing aspects related to self-perception and self-efficacy in the work environment.
* Assess any correlations between what emerged from the psychological profile and: socio-demographic data, type of context in which one works, previous exposure to traumatic events, any psychological treatment.
* To assess how the motivation and/or over-involvement of operators in the relevant work contexts may be related to the development of work stress, which in turn could be a predictor with respect to issues inherent in the phenomena of absenteeism, work distress, job abandonment, transfer requests.

Sample size: 500 operators. Since this is an observational study whose analysis approach will be predominantly descriptive, no formal calculation of sample size based on hypothesis testing is planned. Based on the number of health care workers at the Fondazione Policlinico Gemelli IRCCS who meet the inclusion and exclusion criteria, we estimate that we can enroll approximately 500 subjects. As a general indication, this numerosity will allow us to estimate proportions with a maximum standard error of 0.022.

Methodology: Questionnaire administration at 2 times (T0 baseline, T1 after 4 months), with the possibility of questionnaire completion through the Microsoft Forms online platform.

All variables under study will be assessed in the first instance by descriptive statistical techniques. In detail, qualitative variables will be summarized through absolute frequencies and percentages. As for the quantitative variables, their distribution will first be assessed using the Shapiro Wilk test, then where normally distributed they will be expressed as mean and standard deviation (SD), otherwise as median and interquartile range (IQR).

The primary endpoint related to the domain of psychological and occupational well-being, which is purely exploratory, will therefore be analyzed in terms of descriptive statistics, as reported above. The same approach will be followed for the assessment of the domains of relational and occupational well-being, coping strategies, and behavioral All questionnaires will be analyzed with reference to each individual scale, both in terms of overall score and with respect to individual items and through correlation with other tests. Changes between T0 and T1 will be investigated using paired data tests with parametric or nonparametric approach depending on the distribution of the variables themselves. Graphical representations will also be used to better interpret and communicate the results. Data analysis will be conducted using IBM-SPSS v.28.0 software.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Work activity carried out in departments classified as at risk for work-related stress (emergency care, oncology...)
* Willingness to participate in the study and the ability to understand and sign the informed consent form.

Exclusion Criteria:

* Psychological/psychiatric comorbidities
* Inability to sign the informed consent form

Primary outcomes:
measure: Assessment of indicators of work-related psychological well-being using the Maslach Scale (MBI), with evaluation of any differences between a Baseline, and after 4 months
timeFrame: From enrollment (Time 0) to 4 weeks (Time 1)
measure: Assessment of indicators of work-related Stress, using the Perceived Stress Scale (PSS), with evaluation of any differences between a Baseline, and after 4 months.
timeFrame: From enrollment (Time 0) to 4 weeks (Time 1)
Secondary outcomes:
measure: Assessment of coping styles through the Brief-COPE questionnaire, with evaluation of any differences between a Baseline, and after 4 months.
timeFrame: From enrollment (Time 0) to 4 weeks (Time 1)
measure: Evaluation of motivation/attachment to one's work through the Job-related Affective Well-being Scale (JAWS), with evaluation of any differences between a Baseline, and after 4 months.
timeFrame: From enrollment (Time 0) to 4 weeks (Time 1)
measure: Evaluation of Empathy with the Balanced Emotional Empathy Scale - BEES, with evaluation of any differences between a Baseline, and after 4 months.
timeFrame: From enrollment (Time 0) to 4 weeks (Time 1)
measure: Assessment of Quality of Life in the Professional Context through the Professional Quality of Life Scale (ProQOL), with evaluation of any differences between a Baseline, and after 4 months.
timeFrame: From enrollment (Time 0) to 4 weeks (Time 1)
measure: Assessment of Spiritual Well-being (by FACIT-Sp-12), with evaluation of any differences between a Baseline, and after 4 months.
timeFrame: From enrollment (Time 0) to 4 weeks (Time 1)
measure: Evaluation of technostress in workplace settings, with evaluation of any differences between a Baseline, and after 4 months.
timeFrame: From enrollment (Time 0) to 4 weeks (Time 1)
measure: Assessing Resilience (with RS-14) with evaluation of any differences between a Baseline, and after 4 months.
timeFrame: From enrollment (Time 0) to 4 weeks (Time 1)
Other outcomes:
Locations:
Study officials:
References:
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