Effect of Verbal De-Escalation-Based Simulation on Agitation Management, Perception of Aggression, and Impact of Aggression in Emergency Department Nurses

August 21, 2026 updated by: Şeyma Erkuş, Uskudar University
This mixed-methods randomized controlled study aims to evaluate the effects of verbal de-escalation-based simulation training on emergency department nurses' knowledge of agitation management, perceptions of aggression, and the extent to which they are affected by aggressive and violent behaviors. A total of 78 emergency department nurses will be randomly assigned to an intervention group (n=39) or a control group (n=39). Both groups will receive the same standard training program on verbal de-escalation-based agitation management. After the standard training, the intervention group will participate in standardized patient simulation and debriefing sessions. Outcomes will be assessed before the intervention, after the intervention, and at a three-month follow-up. In addition, focus group interviews will be conducted with participants in the intervention group at the three-month follow-up to explore their experiences with the simulation-based training.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Bursa
      • Bursa, Bursa, Turkey (Türkiye), 16000
        • Public Hospital
        • Contact:
        • Principal Investigator:
          • Şeyma Erkuş, PhD Student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Working as a nurse in the adult emergency department of the hospital where the study will be conducted
  • Working full-time as a nurse
  • Willing to participate in the study

Exclusion Criteria:

  • Being on leave or otherwise unable to work during the study period
  • Having previously received simulation-based training on verbal de-escalation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants in this arm will receive the standard training program on verbal de-escalation-based agitation management, followed by standardized patient simulation and debriefing sessions.
Participants will receive a five-session standard training program on verbal de-escalation-based agitation management. The program covers recognition of agitation and aggression, perceptions and interpretation of aggression, assessment and safe management of the agitated patient, verbal de-escalation principles and techniques, and approaches to protect and strengthen nurses' well-being.
Following the standard training, participants in the intervention group will take part in a standardized patient simulation involving an agitated patient. The simulation includes prebriefing, scenario-based practice, and structured debriefing based on the PEARLS framework. A structured observation form will be used to provide feedback during debriefing and will not be used as an outcome measure.
Active Comparator: Control Group
Participants in this arm will receive the standard training program on verbal de-escalation-based agitation management.
Participants will receive a five-session standard training program on verbal de-escalation-based agitation management. The program covers recognition of agitation and aggression, perceptions and interpretation of aggression, assessment and safe management of the agitated patient, verbal de-escalation principles and techniques, and approaches to protect and strengthen nurses' well-being.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Agitation Management Knowledge Test Score
Time Frame: Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
Agitation management knowledge will be assessed using the researcher-developed Agitation Management Knowledge Test. The test consists of 25 items with three response options: True, False, and Don't Know. Total scores range from 0 to 100, with higher scores indicating greater knowledge of agitation management and verbal de-escalation.
Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
Change in Functional Perception of Aggression Score
Time Frame: Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
Functional perception of aggression will be assessed using the functional subscale of the Perception of Aggression Scale (POAS). The POAS consists of 29 items rated on a 5-point Likert scale. The functional subscale consists of 12 items. The mean subscale score is calculated by dividing the sum of the item scores by the number of items in the subscale and ranges from 1 to 5. Higher scores indicate a greater tendency to perceive aggression as functional, acceptable, and a healthy response.
Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
Change in Dysfunctional Perception of Aggression Score
Time Frame: Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
Dysfunctional perception of aggression will be assessed using the dysfunctional subscale of the Perception of Aggression Scale (POAS). The POAS consists of 29 items rated on a 5-point Likert scale. The dysfunctional subscale consists of 17 items. The mean subscale score is calculated by dividing the sum of the item scores by the number of items in the subscale and ranges from 1 to 5. Higher scores indicate a greater tendency to perceive aggression as dysfunctional, unacceptable, and undesirable.
Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
Change in Impact of Patient Aggression Score
Time Frame: Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
Impact of patient aggression will be assessed using the Impact of Patient Aggression on Carers Scale (IMPACS). The scale consists of 7 items and two subscales: Corruption of Relation Between Care Provider and Patient and Not Feeling Confident. Total scores range from 7 to 35, with higher scores indicating a greater negative impact of patient aggression.
Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Simulation Effectiveness Score
Time Frame: Immediately after completion of the debriefing session following the simulation.
Perceived simulation effectiveness will be assessed using the Modified Simulation Effectiveness Tool (SET-M) in the intervention group. The scale consists of 19 items and four subscales: prebriefing, learning, confidence, and debriefing. Total scores range from 19 to 95, with higher scores indicating a more positive perception of the effectiveness of the simulation-based learning experience.
Immediately after completion of the debriefing session following the simulation.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Themes From Semi-Structured Focus Group Interviews on Verbal De-Escalation-Based Simulation Training
Time Frame: 3 months after the intervention.
Participants' experiences with the verbal de-escalation-based simulation training will be examined through focus group interviews using researcher-developed semi-structured interview questions. Interview transcripts will be analyzed using content analysis, and the findings will be reported as qualitative themes. The interviews will address perceived changes in knowledge and skills, transfer of knowledge and skills to clinical practice, perceptions of and emotional responses to agitated patients, and maintenance of training effects in clinical practice.
3 months after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Elçin Babaoğlu Gülseven, Assoc. Prof. Dr., Üsküdar university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to participant privacy and confidentiality considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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