- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Noemí Casaponsa
- Numero di telefono: 43197 0034938960025
- Email: recerca@csapg.cat
Luoghi di studio
-
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Barcelona
-
Barcelona, Barcelona, Spagna
- Reclutamento
- Hospital Clinic
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Contatto:
- Noemí Casaponsa
- Numero di telefono: 43197 0034938960025
- Email: recerca@csapg.cat
-
Investigatore principale:
- Marta Hage
-
Barcelona, Barcelona, Spagna
- Reclutamento
- Sistema d'Emergències Mèdiques de Catalunya
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Contatto:
- Noemí Casaponsa
- Numero di telefono: 43197 0034938960025
- Email: recerca@csapg.cat
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Investigatore principale:
- Mireia Campos
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Calella, Barcelona, Spagna
- Reclutamento
- Corporació de Salut del Maresme i la Selva
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Contatto:
- Noemí Casaponsa
- Numero di telefono: 43197 0034938960025
- Email: recerca@csapg.cat
-
Investigatore principale:
- Sergio Bujaldón
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Terrassa, Barcelona, Spagna
- Reclutamento
- Consorci Sanitari de Terrassa
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Contatto:
- Noemí Casaponsa
- Numero di telefono: 43197 0034938960025
- Email: recerca@csapg.cat
-
Investigatore principale:
- Clara Romero
-
Vilafranca del Penedès, Barcelona, Spagna
- Reclutamento
- Consorci Sanitari de l'Alt Penedès i Garraf
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Contatto:
- Noemí Casaponsa
- Numero di telefono: 0034938960025
- Email: recerca@csapg.cat
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Investigatore principale:
- Genís Cervantes
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Vilafranca del Penedès, Barcelona, Spagna
- Reclutamento
- Institut Català de Salut Àrea Penedès
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Contatto:
- Noemí Casaponsa
- Numero di telefono: 43197 0034938960025
- Email: recerca@csapg.cat
-
Investigatore principale:
- Alberto Domínguez
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Girona
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Girona, Girona, Spagna
- Non ancora reclutamento
- Institut d'Assistència Sanitària
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Contatto:
- Noemí Casaponsa
- Numero di telefono: 43197 0034938960025
- Email: recerca@csapg.cat
-
Investigatore principale:
- María Cruz Rodríguez
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: OTHER
- Prospettive temporali: CROSS_SECTIONAL
Coorti e interventi
Gruppo / Coorte |
|---|
|
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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Collateral effects of work (occupational well-being)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CSAPG-81
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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).
Periodo di condivisione IPD
After publication of main results of the study
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .