NCT06923436

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

April 4, 2025

Last Update Submit

April 23, 2025

Conditions

Keywords

Psychological well-being of health care workers in the hospital settingwork-related stressemotional burdenMotivational aspects of health professionalsoccupational well-beingPerceived StressPerceived stress from the intensive use of digital technology in work settings

Outcome Measures

Primary Outcomes (2)

  • 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

    The Maslach Burnout Inventory (MBI) is a widely used psychological assessment instrument developed for measuring and evaluating burnout of individuals in various professional settings. The MBI is a self-report questionnaire whose purpose is to measure the various dimensions of burnout that include emotional exhaustion, depersonalization and reduced personal accomplishment. Consisting of 22 items, each of which includes 6 different response grades on a Likert scale, this test facilitates the creation of tailored interventions and strategies to prevent or address burnout effectively.

    From enrollment (Time 0) to 4 weeks (Time 1)

  • 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.

    Perceived Stress Scale (PSS) is the most widely used instrument for assessing perceived stress in individuals aimed at measuring the degree to which situations in one's life are rated as stressful. It is a test consisting of 10 questions in which the individual's feelings and thoughts over the previous month are investigated and asked to express the frequency with which these occur using a Likert scale of 5 different grades. Minimum score is 0, maximum score is 40. The items were developed so that they can detect how unpredictable, uncontrollable and overloaded individuals feel their lives are. Scores from 0 to 13: low perceived stress Scores from 14 to 26: moderate perceived stress Scores froom 27 to 40: high perceived stress

    From enrollment (Time 0) to 4 weeks (Time 1)

Secondary Outcomes (7)

  • Assessment of coping styles through the Brief-COPE questionnaire, with evaluation of any differences between a Baseline, and after 4 months.

    From enrollment (Time 0) to 4 weeks (Time 1)

  • 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.

    From enrollment (Time 0) to 4 weeks (Time 1)

  • Evaluation of Empathy with the Balanced Emotional Empathy Scale - BEES, with evaluation of any differences between a Baseline, and after 4 months.

    From enrollment (Time 0) to 4 weeks (Time 1)

  • 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.

    From enrollment (Time 0) to 4 weeks (Time 1)

  • Assessment of Spiritual Well-being (by FACIT-Sp-12), with evaluation of any differences between a Baseline, and after 4 months.

    From enrollment (Time 0) to 4 weeks (Time 1)

  • +2 more secondary outcomes

Study Arms (1)

Hospital health workers

Hospital healthcare workers in departments most considered to be at risk of work-related stress (emergency, oncology)

Behavioral: Psychological Assessment

Interventions

Collection of anamnestic and socio-demographic data, test administration repeated 4 months apart to monitor any changes

Hospital health workers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Callegari C, Bertu L, Lucano M, Ielmini M, Braggio E, Vender S. Reliability and validity of the Italian version of the 14-item Resilience Scale. Psychol Res Behav Manag. 2016 Oct 3;9:277-284. doi: 10.2147/PRBM.S115657. eCollection 2016.

    PMID: 27757055BACKGROUND
  • Palmieri G, Evans C, Hansen V, Brancaleoni G, Ferrari S, Porcelli P, Reitano F, Rigatelli M. Validation of the Italian version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM). Clin Psychol Psychother. 2009 Sep-Oct;16(5):444-9. doi: 10.1002/cpp.646.

    PMID: 19701881BACKGROUND
  • Maresca G, Corallo F, Catanese G, Formica C, Lo Buono V. Coping Strategies of Healthcare Professionals with Burnout Syndrome: A Systematic Review. Medicina (Kaunas). 2022 Feb 21;58(2):327. doi: 10.3390/medicina58020327.

    PMID: 35208650BACKGROUND
  • Pollock A, Campbell P, Cheyne J, Cowie J, Davis B, McCallum J, McGill K, Elders A, Hagen S, McClurg D, Torrens C, Maxwell M. Interventions to support the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic: a mixed methods systematic review. Cochrane Database Syst Rev. 2020 Nov 5;11(11):CD013779. doi: 10.1002/14651858.CD013779.

    PMID: 33150970BACKGROUND
  • Laserna Jimenez C, Casado Montanes I, Carol M, Guix-Comellas EM, Fabrellas N. Quality of professional life of primary healthcare nurses: A systematic review. J Clin Nurs. 2022 May;31(9-10):1097-1112. doi: 10.1111/jocn.16015. Epub 2021 Aug 27.

    PMID: 34453386BACKGROUND
  • National Academies of Sciences, Engineering, and Medicine; National Academy of Medicine; Committee on the Future of Nursing 2020-2030; Flaubert JL, Le Menestrel S, Williams DR, Wakefield MK, editors. The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity. Washington (DC): National Academies Press (US); 2021 May 11. Available from http://www.ncbi.nlm.nih.gov/books/NBK573914/

    PMID: 34524769BACKGROUND
  • Trumello C, Bramanti SM, Ballarotto G, Candelori C, Cerniglia L, Cimino S, Crudele M, Lombardi L, Pignataro S, Viceconti ML, Babore A. Psychological Adjustment of Healthcare Workers in Italy during the COVID-19 Pandemic: Differences in Stress, Anxiety, Depression, Burnout, Secondary Trauma, and Compassion Satisfaction between Frontline and Non-Frontline Professionals. Int J Environ Res Public Health. 2020 Nov 12;17(22):8358. doi: 10.3390/ijerph17228358.

    PMID: 33198084BACKGROUND

MeSH Terms

Conditions

Psychological Well-BeingFractures, StressAffective SymptomsBurnout, PsychologicalOccupational Stress

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorFractures, BoneWounds and InjuriesBehavioral SymptomsStress, PsychologicalOccupational Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 11, 2025

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 27, 2025

Record last verified: 2025-04