NCT07784868

Brief Summary

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.

Trial Health

63
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Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 17, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 17, 2026

Last Update Submit

August 21, 2026

Conditions

Keywords

Verbal De-EscalationAgitation ManagementAggressionSimulation TrainingPatient SimulationNursesEmergency NursingAggression PerceptionImpact of Aggression

Outcome Measures

Primary Outcomes (4)

  • Change in Agitation Management Knowledge Test Score

    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

    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

    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

    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 Outcomes (1)

  • Perceived Simulation Effectiveness Score

    Immediately after completion of the debriefing session following the simulation.

Other Outcomes (1)

  • Qualitative Themes From Semi-Structured Focus Group Interviews on Verbal De-Escalation-Based Simulation Training

    3 months after the intervention.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Standard Verbal De-Escalation TrainingBehavioral: Verbal De-Escalation-Based Simulation Training

Control Group

ACTIVE COMPARATOR

Participants in this arm will receive the standard training program on verbal de-escalation-based agitation management.

Behavioral: Standard Verbal De-Escalation Training

Interventions

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.

Control GroupIntervention Group

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.

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Hospital

Bursa, Bursa, 16000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Elçin Babaoğlu Gülseven, Assoc. Prof. Dr.

    Uskudar University

    STUDY DIRECTOR

Central Study Contacts

Şeyma Erkuş, PhD Student

CONTACT

Elçin Babaoğlu Gülseven, Assoc. Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistical analyst will be blinded to group allocation during the statistical analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 25, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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

Locations