Managing Aggression! Evaluating the Effectiveness of Model-Based Standardized Patient Simulation: A Parallel Mixed-Methods Randomized Controlled Trial
Phase: NA
Conditions: Aggression
Sponsor: Yuksek Ihtisas University

 
STUDY PROTOCOL WITH STATISTICAL ANALYSIS PLAN  
Managing Aggression! Evaluating the Effectiveness of Model-Based Standardized Patient 
Simulation: A Parallel Mixed-Methods Randomized Controlled Trial 
Sponsor / Responsible Party:  
Reyhan Doğan, PhD, RN  
Yuksek Ihtisas University, Faculty of Health Sciences  
 
Study Type: Two-arm Parallel Randomized Controlled Trial  
 
Document Type: Study Protocol With Statistical Analysis Plan  
 
Document Date: 25 January 2026 
 
Version: Version 1.0   
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Managıng Aggressıon! Evaluatıng The Effectıveness Of Model-Based Standardızed 
Patıent Sımulatıon: A Parallel Mıxed-Methods Randomızed Controlled Trıal 
 
Background  
Aggression is a behavior that intentionally aims to cause physical harm to people or property 
(Tordjman, 2022). Encountering aggression and violent behavior from patients is a common 
and challenging situation for both nurses and nursing students (Hallett et al., 2021). Managing 
aggression is a difficult but equally important issue for healthcare professionals (Ayhan and 
Hiçdurmaz, 2020). Inappropriate approaches to aggression can jeopardize quality patient care 
and the safety of healthcare professionals, other patients, and patients' relatives (Ayhan and 
Hiçdurmaz, 2020). The current literature shows that nursing students may be exposed to various 
forms of aggression, including verbal and physical aggression, during clinical practice (Hallett 
et al., 2021). When confronted with aggression, nursing students may feel anxiety, anger, and 
inadequacy, which may lead some to consider leaving the profession (Hallett et al., 2021). 
Therefore, it has become critically important for nursing students to acquire the skills to 
recognize early signs of aggression, assess potential risks, ensure environmental safety, and 
manage aggression using appropriate communication techniques for their academic and clinical 
development (Bulut and Yıldırım, 2024). However, the literature indicates that there are limited 
studies describing effective and structured teaching approaches aimed at improving aggression 
management skills (Casey, 2024). Therefore, aggression management skills need to be 
supported in a practical and safe educational environment. 
Various teaching strategies are used to prepare nursing students for communicating with 
patients who have mental health issues. Methods such as peer education and blended learning 
help students bridge the gap between theoretical knowledge and practical application (Casey, 
2024). However, simulation-based education provides a learning environment where students 
can experience realistic situations without real clinical risk and observe their emotional and 
behavioral responses. The use of simulation is defined as an effective method for preparing 
nursing students for real-life situations (Casey, 2024). Recent studies have shown that model-
based simulation applications can develop not only students' cognitive knowledge level but also 
clinical skills such as emotional regulation, increased performance, and team coordination 
(Gent and Kainth, 2022). However, no simulation study specifically designed for aggression 
management and based on a specific model has been found in the literature yet. 
Rationale 
Simulation-based education provides a safe and structured learning environment where nursing 
students can experience realistic clinical situations without putting patients or themselves at 
risk. Previous studies have shown that simulation improves students' self-confidence, 
communication skills, and clinical decision-making abilities. However, evidence regarding 
structured, model-based simulation interventions specifically designed for aggression 
management is limited. 

This study aims to evaluate the effectiveness of integrated standardized patient simulation with 
the “De-Escalation Model in Simple Form” on nursing students' perceptions of aggression and 
perceived learning outcomes. 
Research Hypotheses: 
H0a: The De-Escalation Model based standardized patient simulation has no statistically 
significant effect on nursing students' perceptions of aggression. 
H1a: The De-Escalation Model based standardized patient simulation has a statistically 
significant effect on nursing students' perceptions of aggression. 
H0b: The De-Escalation Model based standardized patient simulation has no statistically 
significant effect on nursing students' perceived learning levels. 
H1b: The De-Escalation Model based standardized patient simulation has a statistically 
significant effect on nursing students' perceived learning levels. 
Study design  
The study will conduct a convergent parallel mixed-methods design. Quantitative data will be 
collected using a pre-test–post-test randomized controlled trial with an intervention group and 
a control group. Qualitative data will be collected concurrently using a phenomenological 
approach to explore participants’ experiences of the standardized patient simulation. 
Quantitative and qualitative findings will be analyzed separately and integrated during the 
interpretation phase. 
 
Methods  
The study will be conducted in a nursing simulation laboratory within the health sciences 
faculty of a university. 
The study population will consist of fourth-year nursing students enrolled in the Mental Health 
and Psychiatric Nursing course during the 2025-2026 academic year. A total of 56 students will 
be included in the study. 
Participants will be randomly assigned to either the intervention group or the control group 
using a simple randomization method, ensuring an equal number of participants in each group. 
Each group is planned to include 28 participants.  Inclusion Criteria are as follows: (i) being 18 
years of age or older, (ii) having taken and successfully passed the Mental Health and 
Psychiatric Nursing course, (iii) agreeing to participate in the study. Exclusion Criteria are as 
follows: (i) refusing to participate in the study 
The primary outcome measure of the study, perception of aggression, will be measured using 
the Perception of Aggression 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.   

The secondary outcome measure of the study, impact of aggression, will be measured using the 
Impact of Patient Aggression on Carers Scale. A high score on the scale indicates that 
individuals are highly affected by aggression.  
The tertiary outcome measure of the study, perceived learning, will be measured using the 
Perceived Learning Scale. An increase in the scale score indicates an increase in the level of 
perceived learning. All three outcome measures will be assessed at baseline and after the 
intervention in both the intervention and control group.  
In the final stage, qualitative data will be collected from participants in the intervention group 
to examine their learning experiences and perceptions regarding the simulation and intervention 
process. 
A standardized patient will be used for the simulation intervention. Prior to participation, the 
standardized patient will be trained on the simulation scenario, expected behaviors, and 
procedures to ensure consistency between simulation sessions. Written informed consent will 
be obtained from the standardized patient before the study begins. 
Data collection will be conducted in three consecutive phases: (1) Information and pre-test, (2) 
simulation intervention, and (3) post-test and qualitative data collection. 
In the first phase, eligible participants will be informed about the study procedures, objectives, 
and their rights as participants, and written informed consent will be obtained. Prior to the 
intervention, baseline assessments of the outcome measures, including participants’ perceptions 
of aggression and perceived learning levels, will be conducted. 
In the second stage, only participants in the intervention group will receive training in “The De-
Escalation Model in Simple Form” and then participate in an aggression management 
simulation with a standardized patient. The simulation will be conducted in small groups using 
a structured and standardized scenario. During the simulation, nursing students are expected to 
assess environmental safety, recognize early warning signs of aggression, apply the steps of  
The De-Escalation Model in Simple Form (setting limits, clarifying the situation, and problem-
solving), and use therapeutic communication techniques to manage patient agitation. The 
simulation focuses on non-physical de-escalation strategies and emphasizes patient and staff 
safety. Each simulation session will begin with a briefing and conclude with a debriefing session 
facilitated by the research team.  
In the final stage, qualitative data will be collected from participants in the intervention group 
to examine their learning experiences and perceptions of the simulation and intervention 
process. Subsequently, final test assessments will be administered to both the intervention and 
control group using the same outcome measures. 
Statistical analysis  
IBM SPSS Statistics 27 software will be used for the statistical calculations and analyses of the 
quantitative data in the study. When evaluating the study data, frequencies (number, percentage) 
will be used for categorical variables, and descriptive statistics (mean, standard deviation, 
median, minimum, maximum) will be used for numerical variables. The normality assumptions 

of numerical variables will be examined using the Kolmogorov Smirnov normality test. 
Depending on the normality distribution, parametric (Independent Samples T Test, etc.) or non-
parametric (Mann Whitney U, etc.) statistical methods will be used.  Statistical significance in 
the analyses will be interpreted at the p<0.05 level. In the qualitative part of this mixed-methods 
research, the written responses given by students to the questions asked during the debriefing 
phase will be examined using the content analysis method from qualitative data analysis 
methods. In this analysis, the written responses given to the questions asked to students during 
the simulation's analysis phase will be coded.  The data will be organized by analyzing it and 
placing it into relevant categories. The reporting phase, which is the final step of the content 
analysis method, will be completed by presenting the content analysis steps and findings. 
Ethical considerations  
Participation in this study will be voluntary. All participants will be informed about the study's 
objectives, procedures, and their rights as participants, and written informed consent will be 
obtained prior to data collection. Simulation sessions may be video recorded, with the 
participants' consent, solely for educational and evaluation purposes. All recordings will be 
stored securely, accessible only to the research team, and permanently deleted after the study is 
completed. Confidentiality will be ensured through the use of coded data collection forms and 
secure, password-protected digital storage systems. No personally identifiable information will 
be included in the data sets, and study data will be used solely for research purposes and will 
not be shared with third parties. Upon completion of the study, participants in the control group 
will also be offered the same training and simulation intervention. 
References  
1. Tordjman S. Aggressive behavior: A language to be understood. Encephale. 2022 Sep;48 
Suppl 1:S4-S13. doi: 10.1016/j.encep.2022.08.007 
2. Hallett, N., Wagstaff, C., & Barlow, T. (2021). Nursing students' experiences of violence and 
aggression: A 
mixed-methods 
study. 
Nurse 
Education 
Today, 
105, 
105024. 
https://doi.org/10.1016/j.nedt.2021.105024 
3. Ayhan, D., & Hicdurmaz, D. (2020). Psikiyatri servislerinde bir saldırganlık yönetimi olarak 
basitleştirilmiş sakinleştirme modeli. Psikiyatri Hemşireliği Dergisi, 11(3), 251–259. 
https://doi.org/10.14744/phd.2020.80488 
4. Bulut, M., Yıldırım, N. Aggression in psychiatry: a bibliometric analysis. Middle East Curr 
Psychiatry 31, 84 (2024). https://doi.org/10.1186/s43045-024-00476-9 
5. Casey S. Preparing nursing students to communicate with mental health patients: A scoping 
review. Nurse Educ Pract. 2024 Oct;80:104099. doi: 10.1016/j.nepr.2024.104099. 
6. Gent D, Kainth R. Simulation-based procedure training (SBPT) in rarely performed 
procedures: a blueprint for theory-informed design considerations. Adv Simul (Lond). 2022 
May 8;7(1):13. doi: 10.1186/s41077-022-00205-4 
7. Tek Sevı̇ndı̇k S, Firat S, İncı̇ 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. 
2025 
Nov 
13;90:104642. 
doi: 
10.1016/j.nepr.2025.104642 

8. Rovai, A. P., Wighting, M. J., Baker, J. D., & Grooms, L. D. (2009). Development of an 
instrument to measure perceived cognitive, affective, and psychomotor learning in 
traditional and virtual classroom higher education settings. The Internet and Higher 
Education, 12(1), 7-13. 
9. Albayrak E., Canan Güngören, E., Horzum, M.B. (2014). Algılanan öğrenme ölçeğinin 
Türkçe’ye uyarlanması. Ondokuz Mayıs Üniversitesi Eğitim Fakültesi Dergisi, 33(1) 1-27. 
10. Needham I, Abderhalden C, Halfens R., Dassen T., Haug H., Fischer F. The effect of a 
training course in aggression management on mental health nurses’ perceptions of 
aggression: A cluster randomised controlled trial. International Journal of Nursing Studies. 
2005;42: 649–655. 
11. Öner, S. (2011). Psikiyatri hastanelerinde çalışan hemşirelerde hasta agresyonuna 
gösterilen tepkiler ile tükenmişlik arasındaki ilişkinin incelenmesi [Yüksek lisans tezi, 
Düzce Üniversitesi Sağlık Bilimleri Enstitüsü]. 
12. Jansen G, Dassen T, Moorer P. The Perception of Aggression. Scand J Caring Sci, 
1997;11:51–5 
13. Bilgin H, Tulek Z, Ozcan N. Psychometric properties of the Turkish version of the 
Perception of Aggression Scale. J Psychiatr Ment Health Nurs, 2011;18:878–83 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Flow diagram  
Flow diagram 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessed for eligibility (n=56) 
  
No students were excluded 
Allocated to intervention group (n=28) 
Randomised (n=56) 
Intervention group (n=28) 
Standardized Patient Simulation with Simplified 
De-Escalation Model(n=28) 
Control group (n= 28)  
Usual routine (n= 28)  
Allocated to control group (n=28) 
Enrolment 
Allocation 
Intervention 
Analyzed (n= 28) 
Analyzed (n= 28) 
Analysis