- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Noemí Casaponsa
- 전화번호: 43197 0034938960025
- 이메일: recerca@csapg.cat
연구 장소
-
-
Barcelona
-
Barcelona, Barcelona, 스페인
- 모병
- Hospital Clinic
-
연락하다:
- Noemí Casaponsa
- 전화번호: 43197 0034938960025
- 이메일: recerca@csapg.cat
-
수석 연구원:
- Marta Hage
-
Barcelona, Barcelona, 스페인
- 모병
- Sistema d'Emergències Mèdiques de Catalunya
-
연락하다:
- Noemí Casaponsa
- 전화번호: 43197 0034938960025
- 이메일: recerca@csapg.cat
-
수석 연구원:
- Mireia Campos
-
Calella, Barcelona, 스페인
- 모병
- Corporació de Salut del Maresme i la Selva
-
연락하다:
- Noemí Casaponsa
- 전화번호: 43197 0034938960025
- 이메일: recerca@csapg.cat
-
수석 연구원:
- Sergio Bujaldón
-
Terrassa, Barcelona, 스페인
- 모병
- Consorci Sanitari de Terrassa
-
연락하다:
- Noemí Casaponsa
- 전화번호: 43197 0034938960025
- 이메일: recerca@csapg.cat
-
수석 연구원:
- Clara Romero
-
Vilafranca del Penedès, Barcelona, 스페인
- 모병
- Consorci Sanitari de l'Alt Penedès i Garraf
-
연락하다:
- Noemí Casaponsa
- 전화번호: 0034938960025
- 이메일: recerca@csapg.cat
-
수석 연구원:
- Genís Cervantes
-
Vilafranca del Penedès, Barcelona, 스페인
- 모병
- Institut Català de Salut Àrea Penedès
-
연락하다:
- Noemí Casaponsa
- 전화번호: 43197 0034938960025
- 이메일: recerca@csapg.cat
-
수석 연구원:
- Alberto Domínguez
-
-
Girona
-
Girona, Girona, 스페인
- 아직 모집하지 않음
- Institut d'Assistència Sanitària
-
연락하다:
- Noemí Casaponsa
- 전화번호: 43197 0034938960025
- 이메일: recerca@csapg.cat
-
수석 연구원:
- María Cruz Rodríguez
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: OTHER
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
|---|
|
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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Collateral effects of work (occupational well-being)
기간: 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)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CSAPG-81
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
After publication of main results of the study
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .