- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07926802
Impact of External Workplace Violence on the Occupational Well-being of Healthcare Workers
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
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Noemí Casaponsa
- Phone Number: 43197 0034938960025
- Email: recerca@csapg.cat
Study Locations
-
-
Barcelona
-
Barcelona, Barcelona, Spain
- Recruiting
- Hospital Clinic
-
Contact:
- Noemí Casaponsa
- Phone Number: 43197 0034938960025
- Email: recerca@csapg.cat
-
Principal Investigator:
- Marta Hage
-
Barcelona, Barcelona, Spain
- Recruiting
- Sistema d'Emergències Mèdiques de Catalunya
-
Contact:
- Noemí Casaponsa
- Phone Number: 43197 0034938960025
- Email: recerca@csapg.cat
-
Principal Investigator:
- Mireia Campos
-
Calella, Barcelona, Spain
- Recruiting
- Corporació de Salut del Maresme i la Selva
-
Contact:
- Noemí Casaponsa
- Phone Number: 43197 0034938960025
- Email: recerca@csapg.cat
-
Principal Investigator:
- Sergio Bujaldón
-
Terrassa, Barcelona, Spain
- Recruiting
- Consorci Sanitari de Terrassa
-
Contact:
- Noemí Casaponsa
- Phone Number: 43197 0034938960025
- Email: recerca@csapg.cat
-
Principal Investigator:
- Clara Romero
-
Vilafranca del Penedès, Barcelona, Spain
- Recruiting
- Consorci Sanitari de l'Alt Penedès i Garraf
-
Contact:
- Noemí Casaponsa
- Phone Number: 0034938960025
- Email: recerca@csapg.cat
-
Principal Investigator:
- Genís Cervantes
-
Vilafranca del Penedès, Barcelona, Spain
- Recruiting
- Institut Català de Salut Àrea Penedès
-
Contact:
- Noemí Casaponsa
- Phone Number: 43197 0034938960025
- Email: recerca@csapg.cat
-
Principal Investigator:
- Alberto Domínguez
-
-
Girona
-
Girona, Girona, Spain
- Not yet recruiting
- Institut d'Assistència Sanitària
-
Contact:
- Noemí Casaponsa
- Phone Number: 43197 0034938960025
- Email: recerca@csapg.cat
-
Principal Investigator:
- María Cruz Rodríguez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
How is the study designed?
Design Details
- Observational Models: OTHER
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
|---|
|
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSAPG-81
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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