NCT07438340

Brief Summary

This study aims to evaluate the effectiveness of standardized patient simulation based on "The De-Escalation Model in Simple Form" on nursing students' perceptions of aggression and perceived learning outcomes. Encountering aggressive and violent patient behavior is a common and challenging experience for nursing students. Simulation-based education offers experiential learning opportunities that can enhance students' confidence and clinical decision-making skills. The study was designed using a convergent parallel mixed-methods approach. The quantitative component consists of a randomized controlled trial design in which participants will be randomly assigned to either the intervention group or the control group. Primary and secondary outcome measures related to aggression perception and perceived learning will be assessed post-test in both groups. The intervention group will receive training based on the De-Escalation Model in Simple Form, followed by participation in an aggression management simulation with a standard patient. After the simulation, qualitative data will be collected from participants in the intervention group to examine their experiences, perceptions, and reactions to the intervention and simulation process. Quantitative and qualitative findings will be analyzed to provide a comprehensive understanding of the intervention's effectiveness and implementation process. The results of this study are expected to contribute to evidence-based educational practices aimed at improving nursing students' skills in managing aggressive patient behavior.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

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

January 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

January 1, 2026

Enrollment Period

Same day

First QC Date

January 25, 2026

Last Update Submit

February 22, 2026

Conditions

Keywords

AggressionAggressive PatientAggression ManagementDe-Escalation Model in The Simple FormStandardized Patient Simulation

Outcome Measures

Primary Outcomes (1)

  • Perception of Aggression (Perception of Aggression Scale)

    The scale consists of 29 items and has two subscales: Functional (acceptable-healthy reaction) and Dysfunctional (unacceptable-undesirable aggression). The scale is a five-point Likert-type scale. A score between 29 and 145 is obtained from the entire scale. A high mean score on the functional subscale indicates that aggression is perceived as functional/acceptable, while a high mean score on the dysfunctional subscale indicates that aggression is perceived as dysfunctional/unacceptable.

    Baseline, immediately after the intervention

Secondary Outcomes (1)

  • Impact of aggression (Impact of Patient Aggression on Carers Scale)

    Baseline, immediately after the intervention

Other Outcomes (1)

  • Perceived Learning (Perceived Learning Scale)

    Baseline, immediately after the intervention

Study Arms (2)

Standardized Patient Simulation Group

EXPERIMENTAL

Participants assigned to this group will receive a standardized, patient-centered simulation intervention focused on aggression management using the The De-Escalation Model in Simple Form. The simulation takes place in a nursing simulation laboratory and includes a trained, standardized patient who portrays an acutely agitated psychiatric patient. Nursing students are expected to assess environmental safety, recognize early signs of aggression, and apply the steps of The De-Escalation Model in Simple Form using therapeutic communication and tension-reducing strategies. The intervention includes a structured briefing, an active simulation scenario emphasizing non-physical calming strategies and therapeutic communication, and a facilitated debriefing session.

Behavioral: Standardized Patient Simulation Based on the De-Escalation Model in Simple Form

Control group

NO INTERVENTION

Participants in the control arm will receive standard theoretical instruction on aggression management as part of the regular Mental Health and Psychiatric Nursing curriculum, without participation in a standardized patient simulation. No simulation-based or experiential intervention will be provided to this group during the study period.

Interventions

The intervention consists of a standardized patient-based simulation designed to improve nursing students' aggression management skills using the De-Escalation Model. During the simulation, a trained standardized patient portrays an acutely agitated psychiatric patient in a simulated clinical environment. Nursing students are expected to assess environmental safety, recognize early warning signs of aggression, apply the steps of the De-Escalation Model (setting limits, clarifying the situation, and problem-solving), and use therapeutic communication techniques to de-escalate patient agitation. The simulation session includes a briefing, an active simulation scenario, and a facilitated debriefing session led by the research team.

Standardized Patient Simulation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being 18 years of age
  • having taken and successfully passed the Mental Health and Psychiatric Nursing course
  • agreeing to participate in the study

You may not qualify if:

  • refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtisas University, Faculty of Health Sciences

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Tek Sevi̇ndi̇k S, Firat S, Inci̇ F. The effect of video assisted aggression assessment training on psychiatric nurses' aggression perceptions and violence risk assessments; A randomised controlled study. Nurse Educ Pract. 2026 Jan;90:104642. doi: 10.1016/j.nepr.2025.104642. Epub 2025 Nov 13.

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Reyhan DOĞAN

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reyhan Doğan, PhD, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatric Nursing

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 27, 2026

Study Start

February 1, 2026

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations