- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06921083
Violence in ICU: Outcomes, Lessons, and Experiences of ICU Team (The VIOLENT-Study)
Investigating Management and Perceptions of Aggression, Conflict, and Threat in ICU Environments
Study Overview
Status
Conditions
Detailed Description
Workplace violence, as defined by the International Labor Organization, includes any action, incident, or behavior that assaults, threatens, harms, or injures a person during their work. Healthcare workers face the highest risk of workplace violence among all professions. Violence can take many forms, including verbal abuse, physical offenses to sexual harassment. While most research focuses on psychiatric and emergency departments, workplace violence in intensive care units (ICUs) is understudied and often underreported. As a result, little is known about its prevalence and risk factors, leading to a lack of awareness and effective prevention strategies.
This study examines the perceptions, experiences, and responses of healthcare professionals in Swiss ICUs. A questionnaire-based survey will assess various aspects, including personal background (such as education and professional role), the frequency and nature of past incidents of workplace violence, responses and measures taken, psychological or professional consequences, current prevention strategies, and suggestions for improving workplace safety.
Since workplace violence is a common issue, the results of this study could help improve the work environment and safety in ICUs and other healthcare settings.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Raoul Sutter, Prof. Dr. med.
- Phone Number: +41 61 32 87928
- Email: raoul.sutter@usb.ch
Study Locations
-
-
Basel-Stadt
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Basel, Basel-Stadt, Switzerland, 4031
- Recruiting
- University Hospital Basel, Intensive Care Unit
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Principal Investigator:
- Raoul Sutter, Prof. Dr. med.
-
Sub-Investigator:
- Sebastian Berger, Dr. med.
-
Contact:
- Raoul Sutter, Prof. Dr. med.
- Phone Number: +41 61 32 87928
- Email: raoul.sutter@usb.ch
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Sub-Investigator:
- Anja Frei
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Consenting nurses and physicians currently working in Swiss intensive care units
- Nurses and physicians consenting to participate will be included
Exclusion Criteria:
- Nurses and physicians who do not consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic information (ICU Staff Questionnaire)
Time Frame: 2025
|
Participants provide demographic details, including gender and age, using a questionnaire.
|
2025
|
|
Completion date (ICU Staff Questionnaire)
Time Frame: 2025
|
The date of questionnaire completion is recorded.
|
2025
|
|
Professional background (ICU Staff Questionnaire)
Time Frame: 2025
|
Assessment of professional role of the intensive care unit (ICU) staff, including their education and work experience, using a questionnaire.
|
2025
|
|
Frequency of violent incident (ICU Staff Questionnaire)
Time Frame: 2025
|
Participants report the frequency of violent incidents encountered from patients or their relatives in the ICU setting, using a questionnaire.
|
2025
|
|
Type of violent incident (ICU Staff Questionnaire)
Time Frame: 2025
|
Participants report the type of violent incidents (verbal, physical, and sexual) encountered from patients or their relatives in the ICU setting, using a questionnaire.
|
2025
|
|
Characteristics of violent incident (ICU Staff Questionnaire)
Time Frame: 2025
|
Participants provide detailed information about specific violent incidents they have experienced in the ICU, including the context and perceived triggers, using a questionnaire.
|
2025
|
|
Reporting of violent incident (ICU Staff Questionnaire)
Time Frame: 2025
|
Participants report whether the violent incident has been reported, using a questionnaire.
|
2025
|
|
Personal impact of workplace violence (ICU Staff Questionnaire)
Time Frame: 2025
|
Participants describe the personal impact of workplace violence, including psychological and mental health consequences, using a questionnaire.
|
2025
|
|
Professional impact of workplace violence (ICU Staff Questionnaire)
Time Frame: 2025
|
Participants report how workplace violence influences professional factors such as job satisfaction and workload, using a questionnaire.
|
2025
|
|
Actions taken during or after violent incident (ICU Staff Questionnaire)
Time Frame: 2025
|
Participants report the responses and measures taken during or after the violent incident, using a questionnaire.
|
2025
|
|
Strategies for enhancing workplace safety in the ICU (ICU Staff Questionnaire)
Time Frame: 2025
|
Participants provide information on strategies for enhancing workplace safety in the ICU, such as existing institutional policies, prior training in handling workplace violence, and their opinions on workplace violence prevention and recommendations for enhancing ICU safety, using a questionnaire.
|
2025
|
|
Open-ended feedback from participant (ICU Staff Questionnaire)
Time Frame: 2025
|
Participants have the opportunity to share additional comments or remarks related to workplace violence and safety in the ICU, using a questionnaire.
This information is collected through a freetext field in the questionnaire.
|
2025
|
Collaborators and Investigators
Investigators
- Principal Investigator: Raoul Sutter, Prof. Dr. med., University Hospital Basel, Department of Acute Medicine, Intensive Care Unit
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Req-2024-01621; am25Sutter2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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