Workplace ViolenceSanidad-SeguraNCT07473531
Chatbot to Support Healthcare Professionals Experiencing Workplace Aggression
An observational study of Workplace Violence and Health Professionals, run by Distrito Sanitario Almeria at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Workplace Violence, Health Professionals, Chatbot
- What is being tested?
- Chatbot SANIDAD SEGURA
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2026to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare professionals working in the Critical Care and Emergency Units of the Almería Health District (Spain)
Who may be able to join
- 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.
Who cannot join
- Healthcare professionals currently undergoing formal institutional intervention related to workplace aggression
- Individuals who decline to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Workplace Violence, Health Professionals, Chatbot, Digital Health
- Being tested
- Chatbot SANIDAD SEGURA
- Keywords
- Digital Health, Workplace Violence, Chatbots, Health Technology, Health professionals, Aggressions
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot SANIDAD SEGURADevice
Also called CHATBOT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Chatbot SANIDAD SEGURA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chatbot Usability Assessed by the System Usability Scale (SUS)
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.
Measured: Immediately after the intervention
Readability of Chatbot Responses Assessed Using the INFLESZ Scale
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.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start19 Feb 2026
- Primary completion3 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Workplace ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Distrito Sanitario Almeria
- Sponsor type
- Other government
- Collaborators
- Junta de Andalucia
- Responsible party
- Principal investigator, Alba García Viola, Distrito Sanitario Almeria
- Investigators
- Alba García Viola, PhD, RN, Principal investigator, Distrito Sanitario Almería
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473531
- Sponsor's protocol ID
- AP-0451-2024-C5-F2 FPS 2020
- Other IDs
- AP-0451-2024-C5-F2 FPS 2020
- Acronym
- Sanidad-Segura
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant privacy and confidentiality, in accordance with applicable ethical and regulatory standards.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Development and Validation of a Chatbot (SANIDAD SEGURA) to Support Healthcare Professionals Experiencing Workplace Aggression: Protocol for a Mixed-methods Study
- ClinicalTrials.gov ID
- NCT07473531
- Acronym / sponsor ID
- Sanidad-Segura / AP-0451-2024-C5-F2 FPS 2020
- Conditions
- Workplace Violence, Health Professionals, Chatbot, Digital Health
- Keywords
- Digital Health, Workplace Violence, Chatbots, Health Technology, Health professionals, Aggressions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Distrito Sanitario AlmeriaOther government
- Collaborators
- Junta de Andalucia
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 3 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare Professionals Using the Chatbot (SANIDAD SEGURA) | – | Device: Chatbot SANIDAD SEGURAHealthcare 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare professionals working in the Critical Care and Emergency Units of the Almería Health District (Spain)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Healthcare professionals currently undergoing formal institutional intervention related to workplace aggression
- Individuals who decline to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chatbot SANIDAD SEGURAAlso: CHATBOTSANIDAD 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. | Device | Healthcare Professionals Using the Chatbot (SANIDAD SEGURA) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant privacy and confidentiality, in accordance with applicable ethical and regulatory standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alba García Viola, PhD, RN principal investigator
Distrito Sanitario Almería
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Workplace Violence and Health Professionals, run by Distrito Sanitario Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chatbot Usability Assessed by the System Usability Scale (SUS) (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.