Workplace ViolenceNCT07926802
Impact of External Workplace Violence on the Occupational Well-being of Healthcare Workers
An observational study of Workplace Violence and Burnout, Professionals, run by Consorci Sanitari de l'Alt Penedès i Garraf at 7 sites in Spain.
Trial summary
The goal of this observational study is to learn whether external workplace violence (violence by patients, relatives, or companions) is associated with poorer occupational well-being in healthcare workers aged 18 years or older who have regular face-to-face contact with patients or their families. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Workplace Violence, Burnout, Professionals
- How many people
- 442 participants
- Where
- 7 sitesSpain
- Study dates
- 24 Feb 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Active healthcare workers of the participating centers whose work involves direct and regular contact with external users (patients, relatives, or companions), including clinical, technical, auxiliary, and administrative or front-desk staff
Who may be able to join
- Aged 18 years or older
- At least 12 months of employment at the study center
- Active healthcare worker whose work involves direct and regular contact with external users (patients, relatives, or companions), defined as at least one face-to-face interaction on 2 or more days in a typical working week
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
Hospital Clinic
Barcelona, Barcelona
Noemí Casaponsa, 0034938960025 ext. 43197, recerca@csapg.cat
Marta Hage
- Recruiting
Sistema d'Emergències Mèdiques de Catalunya
Barcelona, Barcelona
Noemí Casaponsa, 0034938960025 ext. 43197, recerca@csapg.cat
Mireia Campos
- Recruiting
Corporació de Salut del Maresme i la Selva
Calella, Barcelona
Noemí Casaponsa, 0034938960025 ext. 43197, recerca@csapg.cat
Sergio Bujaldón
- Not yet recruiting
Institut d'Assistència Sanitària
Girona, Girona
Noemí Casaponsa, 0034938960025 ext. 43197, recerca@csapg.cat
María Cruz Rodríguez
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona
Noemí Casaponsa, 0034938960025 ext. 43197, recerca@csapg.cat
Clara Romero
- Recruiting
Consorci Sanitari de l'Alt Penedès i Garraf
Vilafranca del Penedès, Barcelona
Noemí Casaponsa, 0034938960025, recerca@csapg.cat
Genís Cervantes
- Recruiting
Institut Català de Salut Àrea Penedès
Vilafranca del Penedès, Barcelona
Noemí Casaponsa, 0034938960025 ext. 43197, recerca@csapg.cat
Alberto Domínguez
About this study
Official title: Impact of External Occupational Violence on Healthcare Professionals and Organizations: a Multicenter Cross-sectional Study
The goal of this observational study is to learn whether external workplace violence (violence by patients, relatives, or companions) is associated with poorer occupational well-being in healthcare workers aged 18 years or older who have regular face-to-face contact with patients or their families. The main questions it aims to answer are:
- Do healthcare workers who have experienced external workplace violence in the past 12 months report more negative effects of work (somatization, exhaustion, and alienation) than those who have not?
- How common is external workplace violence, what types occur (physical, verbal, symbolic, digital, or economic), and how intense are they?
- Is external workplace violence associated with working conditions and organizational practices? Researchers will compare healthcare workers who have experienced external workplace violence with those who have not to see if their occupational well-being scores differ.
Participants will complete a single anonymous online survey about their experience of workplace violence, their occupational well-being, their working conditions, and the measures they consider most effective to reduce violence.
Read the detailed description
This multicenter cross-sectional study will be conducted in seven healthcare organizations with different profiles. Participants will be randomly selected from the staff census of each center, stratified by area or department, and invited to complete an anonymous online survey hosted on the REDCap platform of the sponsor. The survey includes the collateral effects dimension of the General Occupational Well-being Questionnaire (cBLG; somatization, exhaustion, and alienation scales; total score 13-91), 22 items of the Working Conditions Questionnaire (cCT; score 0-220), 6 ad hoc items on organizational practices (score 0-60), self-reported workplace violence in the past 12 months by type and intensity, and sociodemographic and occupational variables.
The primary analysis will compare mean collateral effects scores between workers with and without external workplace violence using Student's t test, followed by multivariable analyses adjusted for sex, age group, professional category, care setting, work shift, type of contract, and seniority. Subgroup analyses by sex, professional category, and center, and a dose-response analysis by violence intensity, are planned.
- Conditions
- Workplace Violence, Burnout, Professionals
- Keywords
- healthcare workers, occupational well-being, aggression; patient violence
- Medical subject headings
- Burnout, Psychological, Aggression
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 workers with external workplace violence | Workers who self-report at least one episode of external workplace violence (physical, verbal, symbolic, digital, or economic) in the past 12 months | |
| Healthcare workers without external workplace violence | Workers who report no episodes of external workplace violence in the past 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collateral effects of work (occupational well-being)
Sum of the somatization (5 items), exhaustion (4 items), and alienation (4 items) scales of the collateral effects dimension of the General Occupational Well-being Questionnaire (cBLG; Blanch et al.). Total score range: 13 to 91; higher scores indicate greater deterioration of occupational well-being.
Measured: At survey completion (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start24 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Workplace ViolenceStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07926802
- Sponsor's protocol ID
- CSAPG-81
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of External Occupational Violence on Healthcare Professionals and Organizations: a Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07926802
- Acronym / sponsor ID
- CSAPG-81
- Conditions
- Workplace Violence, Burnout, Professionals
- Keywords
- healthcare workers, occupational well-being, aggression; patient violence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Nov 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 goal of this observational study is to learn whether external workplace violence (violence by patients, relatives, or companions) is associated with poorer occupational well-being in healthcare workers aged 18 years or older who have regular face-to-face contact with patients or their families. The main questions it aims to answer are:
- Do healthcare workers who have experienced external workplace violence in the past 12 months report more negative effects of work (somatization, exhaustion, and alienation) than those who have not?
- How common is external workplace violence, what types occur (physical, verbal, symbolic, digital, or economic), and how intense are they?
- Is external workplace violence associated with working conditions and organizational practices? Researchers will compare healthcare workers who have experienced external workplace violence with those who have not to see if their occupational well-being scores differ.
Participants will complete a single anonymous online survey about their experience of workplace violence, their occupational well-being, their working conditions, and the measures they consider most effective to reduce violence.
Detailed description
This multicenter cross-sectional study will be conducted in seven healthcare organizations with different profiles. Participants will be randomly selected from the staff census of each center, stratified by area or department, and invited to complete an anonymous online survey hosted on the REDCap platform of the sponsor. The survey includes the collateral effects dimension of the General Occupational Well-being Questionnaire (cBLG; somatization, exhaustion, and alienation scales; total score 13-91), 22 items of the Working Conditions Questionnaire (cCT; score 0-220), 6 ad hoc items on organizational practices (score 0-60), self-reported workplace violence in the past 12 months by type and intensity, and sociodemographic and occupational variables.
The primary analysis will compare mean collateral effects scores between workers with and without external workplace violence using Student's t test, followed by multivariable analyses adjusted for sex, age group, professional category, care setting, work shift, type of contract, and seniority. Subgroup analyses by sex, professional category, and center, and a dose-response analysis by violence intensity, are planned.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers with external workplace violence | – | –Workers who self-report at least one episode of external workplace violence (physical, verbal, symbolic, digital, or economic) in the past 12 months |
| Healthcare workers without external workplace violence | – | –Workers who report no episodes of external workplace violence in the past 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Active healthcare workers of the participating centers whose work involves direct and regular contact with external users (patients, relatives, or companions), including clinical, technical, auxiliary, and administrative or front-desk staff
Key inclusion criteria (3 listed)
- Aged 18 years or older
- At least 12 months of employment at the study center
- Active healthcare worker whose work involves direct and regular contact with external users (patients, relatives, or companions), defined as at least one face-to-face interaction on 2 or more days in a typical working week
Key exclusion criteria (1 listed)
- Refusal to participate in the study
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
Collateral effects of work (occupational well-being)
Time frame: At survey completion (single time point)
Sum of the somatization (5 items), exhaustion (4 items), and alienation (4 items) scales of the collateral effects dimension of the General Occupational Well-being Questionnaire (cBLG; Blanch et al.). Total score range: 13 to 91; higher scores indicate greater deterioration of occupational well-being.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Workplace Violence and Burnout, Professionals, run by Consorci Sanitari de l'Alt Penedès i Garraf at 7 sites in Spain.
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 3 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: looking for participants now, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noemí Casaponsa (0034938960025 ext. 43197, recerca@csapg.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collateral effects of work (occupational well-being) (time frame: At survey completion (single time point)). 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 9 Nov 2026.