Impact of External Workplace Violence on the Occupational Well-being of Healthcare Workers

November 3, 2026 updated by: Consorci Sanitari de l'Alt Penedès i Garraf

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
442

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain
        • Recruiting
        • Hospital Clinic
        • Contact:
        • Principal Investigator:
          • Marta Hage
      • Barcelona, Barcelona, Spain
        • Recruiting
        • Sistema d'Emergències Mèdiques de Catalunya
        • Contact:
        • Principal Investigator:
          • Mireia Campos
      • Calella, Barcelona, Spain
        • Recruiting
        • Corporació de Salut del Maresme i la Selva
        • Contact:
        • Principal Investigator:
          • Sergio Bujaldón
      • Terrassa, Barcelona, Spain
        • Recruiting
        • Consorci Sanitari de Terrassa
        • Contact:
        • Principal Investigator:
          • Clara Romero
      • Vilafranca del Penedès, Barcelona, Spain
        • Recruiting
        • Consorci Sanitari de l'Alt Penedès i Garraf
        • Contact:
        • Principal Investigator:
          • Genís Cervantes
      • Vilafranca del Penedès, Barcelona, Spain
        • Recruiting
        • Institut Català de Salut Àrea Penedès
        • Contact:
        • Principal Investigator:
          • Alberto Domínguez
    • Girona
      • Girona, Girona, Spain
        • Not yet recruiting
        • Institut d'Assistència Sanitària
        • Contact:
        • Principal Investigator:
          • María Cruz Rodríguez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: OTHER
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At survey completion (single time point)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Consorci Sanitari de l'Alt Penedès i Garraf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSAPG-81

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

After publication of main results of the study

IPD Sharing Access Criteria

IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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