NCT07473531

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

March 9, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Digital HealthWorkplace ViolenceChatbotsHealth TechnologyHealth professionalsAggressions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Immediately after the intervention

Other Outcomes (1)

  • User Acceptability and Satisfaction With the Chatbot

    Immediately after the intervention

Study Arms (1)

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.

Device: Chatbot SANIDAD SEGURA

Interventions

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.

Also known as: CHATBOT
Healthcare Professionals Using the Chatbot (SANIDAD SEGURA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthcare professionals working in the Critical Care and Emergency Units of the Almería Health District (Spain)

You may qualify if:

  • 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.

You may not qualify if:

  • Healthcare professionals currently undergoing formal institutional intervention related to workplace aggression
  • Individuals who decline to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Distrito Sanitario Almería

Almería, Almería, Spain

Location

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Alba García Viola, PhD, RN

    Distrito Sanitario Almería

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 16, 2026

Study Start

February 19, 2026

Primary Completion

May 3, 2026

Study Completion

June 1, 2026

Last Updated

June 3, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared to protect participant privacy and confidentiality, in accordance with applicable ethical and regulatory standards.

Locations