- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07473531
Chatbot to Support Healthcare Professionals Experiencing Workplace Aggression (Sanidad-Segura)
Design, Development and Validation of a Chatbot (SANIDAD SEGURA) to Support Healthcare Professionals Experiencing Workplace Aggression: Protocol for a Mixed-methods Study
This study aims to design, develop, and validate a chatbot (SANIDAD SEGURA) intended to support healthcare professionals who experience workplace aggression.
Workplace violence in healthcare settings is a growing global concern and has been associated with negative psychological, professional, and organizational consequences. Despite the existence of prevention and reporting protocols, many incidents remain underreported and affected professionals often lack immediate, confidential access to guidance and support.
SANIDAD SEGURA is a digital conversational agent designed to provide accessible information, guidance, and referral to institutional, psychological, and legal resources following aggressive incidents. The study will evaluate the usability, readability, and preliminary effectiveness of the chatbot among healthcare professionals working in emergency and critical care units.
The study seeks to determine whether a chatbot-based tool can serve as a feasible and acceptable digital resource to assist professionals exposed to workplace aggression and facilitate access to support resources while contributing to improved reporting and understanding of workplace violence in healthcare settings.
Study Overview
Status
Intervention / Treatment
Detailed Description
Workplace aggression toward healthcare professionals has become an increasingly significant occupational and public health concern worldwide. Exposure to physical, verbal, or psychological aggression can lead to adverse consequences including emotional distress, burnout, reduced job satisfaction, and increased turnover intention. Additionally, workplace violence negatively affects healthcare organizations by increasing absenteeism, reducing productivity, and potentially compromising patient safety.
Although healthcare systems have implemented prevention protocols and reporting mechanisms, underreporting of aggressive incidents remains common. Barriers such as fear of retaliation, normalization of violence, lack of time, and limited access to confidential support mechanisms often discourage healthcare workers from formally reporting incidents or seeking assistance.
Digital health technologies, particularly conversational agents or chatbots based on natural language processing, have emerged as promising tools to provide scalable, accessible, and continuous support. These tools can deliver real-time information, psychoeducational guidance, and referral pathways, potentially reducing barriers to help-seeking behaviors.
The SANIDAD SEGURA chatbot has been developed to address this gap by providing healthcare professionals with an accessible digital platform to obtain guidance following workplace aggression. The chatbot integrates information on institutional procedures, psychological coping strategies, and legal resources while facilitating confidential reporting and documentation of incidents.
This mixed-methods study will include the design and development of the chatbot, expert content validation, and pilot testing among healthcare professionals working in emergency and critical care settings in the Almería Health District (Spain). The evaluation will focus on the usability, readability, and acceptability of the chatbot, as well as its feasibility as a supportive tool within existing workplace violence prevention frameworks.
The findings of this study will contribute to the development of innovative digital strategies aimed at improving the management, reporting, and prevention of workplace aggression in healthcare environments
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Almería
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Almería, Almería, Spain
- Distrito Sanitario Almería
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthcare professionals working in the Critical Care and Emergency Units of the Almería Health District.
- Active clinical practice in the Almería Health District.
- Age 18 years or older.
- Willingness to participate and provide informed consent.
Exclusion Criteria:
- Healthcare professionals currently undergoing formal institutional intervention related to workplace aggression
- Individuals who decline to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthcare Professionals Using the Chatbot (SANIDAD SEGURA)
Healthcare professionals working in emergency and critical care units who will access and interact with the SANIDAD SEGURA chatbot to obtain guidance and support related to workplace aggression and who will evaluate the usability and readability of the system.
|
SANIDAD SEGURA is a digital conversational agent designed to support healthcare professionals who experience workplace aggression.
The chatbot provides information about institutional procedures, psychological coping strategies, and legal resources related to aggression in healthcare settings.
Participants will interact with the chatbot and subsequently evaluate its usability and readability using standardized instruments.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chatbot Usability Assessed by the System Usability Scale (SUS)
Time Frame: Immediately after the intervention
|
Usability of the SANIDAD SEGURA chatbot will be evaluated using the System Usability Scale (SUS), a validated 10-item questionnaire measuring perceived usability, learnability, efficiency, and satisfaction.
The SUS produces a score ranging from 0 to 100, with higher scores indicating better usability.
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Immediately after the intervention
|
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Readability of Chatbot Responses Assessed Using the INFLESZ Scale
Time Frame: Immediately after the intervention
|
Readability of the chatbot-generated text will be assessed using the INFLESZ scale, which evaluates the difficulty and comprehension level of Spanish-language texts.
Scores range from 0 to 100, with higher scores indicating easier readability.
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Immediately after the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User Acceptability and Satisfaction With the Chatbot
Time Frame: Immediately after the intervention
|
Participant feedback regarding perceived usefulness, clarity of information, and overall experience when interacting with the SANIDAD SEGURA chatbot will be collected through user comments and qualitative feedback.
|
Immediately after the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alba García Viola, PhD, RN, Distrito Sanitario Almería
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- AP-0451-2024-C5-F2 FPS 2020 (Registry Identifier: Fundación Progreso y Salud. Consejería de Salud y Consumo de la Junta de Andalucía)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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