Work StressSICURESNCT07341295
Perception of Stress and Safety Culture: Analysis of Critical Factors in Healthcare (SICURES)
An observational study of Work Stress and Patient Safety, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
The study adopts an observational design, based on a sample of 143 healthcare professionals, using two validated anonymous questionnaires: the Perceived Stress Scale (PSS-10) to measure perceived stress levels and the Hospital Survey on Patient Safety Culture 2.0 (SOPS AHRQ) to assess perceptions of patient safety… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Work Stress, Patient Safety
- How many people
- 164 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jul 2025to 10 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthcare professionals of CCM DAPS'
Who may be able to join
- healthcare professionals of CCM DAPS'
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percezione Dello Stress e Cultura Della Sicurezza: Analisi Dei Fattori Critici in Ambito Sanitario (SICURES)
The study adopts an observational design, based on a sample of 143 healthcare professionals, using two validated anonymous questionnaires: the Perceived Stress Scale (PSS-10) to measure perceived stress levels and the Hospital Survey on Patient Safety Culture 2.0 (SOPS AHRQ) to assess perceptions of patient safety culture.
Data collection will take place at a single point in time and without external intervention, on a sample of healthcare professionals belonging to the various hospital operating units of the CCM.
Read more
Objectives (primary and secondary):
- Primary: This study aims to analyze whether the levels of risk management perceived by healthcare professionals are predictive of perceived stress levels in the same clinical context.
- Secondary:
- Assess the level of stress perceived by healthcare professionals
- Explore the perception of patient safety culture
- Analyze the correlation between perceived stress and safety culture in hospital settings
- Identify possible critical areas or organizational factors that contribute to the onset of stress and influence the perception of safety in care
- Conditions
- Work Stress, Patient Safety
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthcare professionals | healthcare professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship betweemn levels of risk management perceived and perceived stress levels
This study aims to analyze whether the levels of risk management perceived by healthcare professionals are predictive of perceived stress levels in the same clinical context.
Measured: July 2025 - October 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start14 Jul 2025
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341295
- Sponsor's protocol ID
- L2-376
- Acronym
- SICURES
- Status last verified
- Jul 2025
- First submitted
- 15 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percezione Dello Stress e Cultura Della Sicurezza: Analisi Dei Fattori Critici in Ambito Sanitario (SICURES)
- ClinicalTrials.gov ID
- NCT07341295
- Acronym / sponsor ID
- SICURES / L2-376
- Conditions
- Work Stress, Patient Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study adopts an observational design, based on a sample of 143 healthcare professionals, using two validated anonymous questionnaires: the Perceived Stress Scale (PSS-10) to measure perceived stress levels and the Hospital Survey on Patient Safety Culture 2.0 (SOPS AHRQ) to assess perceptions of patient safety culture.
Data collection will take place at a single point in time and without external intervention, on a sample of healthcare professionals belonging to the various hospital operating units of the CCM.
Objectives (primary and secondary):
- Primary: This study aims to analyze whether the levels of risk management perceived by healthcare professionals are predictive of perceived stress levels in the same clinical context.
- Secondary:
- Assess the level of stress perceived by healthcare professionals
- Explore the perception of patient safety culture
- Analyze the correlation between perceived stress and safety culture in hospital settings
- Identify possible critical areas or organizational factors that contribute to the onset of stress and influence the perception of safety in care
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthcare professionals | – | –healthcare professionals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthcare professionals of CCM DAPS'
Key inclusion criteria (1 listed)
- healthcare professionals of CCM DAPS'
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
relationship betweemn levels of risk management perceived and perceived stress levels
Time frame: July 2025 - October 2025
This study aims to analyze whether the levels of risk management perceived by healthcare professionals are predictive of perceived stress levels in the same clinical context.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work Stress and Patient Safety, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship betweemn levels of risk management perceived and perceived stress levels (time frame: July 2025 - October 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.