An interventional study of Experimental Group and Control Group in Healthy Volunteers, sponsored by Near East University, Turkey. Completed at 1 site in Cyprus. Open to participants aged 18 Years to 27 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Near East University, Turkey · Not applicable, Interventional, and Supportive care
This randomized controlled trial aims to evaluate the effectiveness of a standardized patient simulation-based educational intervention among undergraduate nursing students enrolled in the Mental Health Nursing course at the Department of Nursing, Faculty of Health Sciences, Cyprus International University, during the 2025-2026 academic year.
A total of 70 eligible undergraduate nursing students were randomly allocated to an experimental group or a control group. Students in the experimental group participated in a structured simulation-based educational program using trained standardized patients portraying individuals with bipolar disorder. The simulation scenarios represent common clinical presentations of bipolar disorder, including acute manic episodes, depressive episodes , emotional instability, and mixed features associated with medication non-adherence. Students practice mental health assessment, therapeutic communication, therapeutic relationship building, and appropriate nursing interventions, followed by structured debriefing and reflection.
The intervention was based on the principles of Jean Watson's Theory of Human Caring and was delivered through weekly simulation sessions. The control group received the routine Mental Health Nursing curriculum, including theoretical instruction and regular clinical placement experiences, without participation in the standardized patient simulation program.
The primary outcome is therapeutic communication skills, while secondary outcomes include empathy and communication self-efficacy. Outcomes will be assessed using validated assessment scales at baseline and after completion of the intervention. The study evaluate whether standardized patient simulation is more effective than traditional teaching methods in developing key clinical and interpersonal competencies among undergraduate nursing students preparing to care for patients with bipolar disorder.
### Detailed Description
Mental health nursing education requires students to develop not only theoretical knowledge but also the interpersonal and clinical skills needed to establish therapeutic relationships and communicate effectively with individuals experiencing mental health conditions. Traditional teaching approaches may provide limited opportunities for students to practice these skills in realistic and controlled clinical situations.
This study investigate whether standardized patient simulation can provide an effective educational approach for developing key competencies among undergraduate nursing students enrolled in a Mental Health Nursing course. The simulation-based intervention will use trained standardized patients to portray individuals with bipolar disorder in realistic clinical scenarios. The scenarios was design was taking from a textbook of mental health scenarios to reflect different clinical presentations and challenges that nursing students may encounter when caring for individuals with bipolar disorder.
The educational approach incorporated principles derived from Jean Watson's Theory of Human Caring, with particular emphasis on the development of empathy, therapeutic communication, therapeutic relationships, and students' confidence in communicating with patients. Simulation activities provide students with opportunities to apply theoretical knowledge in practice, receive structured feedback, and reflect on their clinical performance through guided debriefing.
The study used a randomized controlled design to compare the simulation-based educational approach with the routine Mental Health Nursing curriculum. The study examine whether participation in standardized patient simulation results in greater improvements in therapeutic communication, empathy, and communication self-efficacy compared with conventional educational approaches.
The findings of this study may contribute to the evidence regarding the use of standardized patient simulation in undergraduate mental health nursing education and may help inform the development of educational strategies aimed at strengthening students' clinical and interpersonal competencies before and during their clinical practice.
Near East University, Turkey is the lead sponsor of 44 studies on the registry; 4 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention: Simulation-Based Education Using Standardized Students Participants assigned to the experimental group received a structured simulation-based educational intervention using trained standardized patients (SPs) portraying individuals with bipolar disorder. The intervention was developed based on the principles of Jean Watson's Theory of Human Caring and will focus on developing students' therapeutic communication skills, empathy, and communication self-efficacy in mental health nursing. The intervention will consist of two simulation sessions per week, with each session lasting approximately 75 minutes. During each session, students will be divided into five groups of seven students. Trained standardized patients portray realistic clinical scenarios representing different presentations and challenges associated with bipolar disorder, including acute manic episodes, depressive episodes , emotional instability, and medication non adherence
Behavioral: Experimental Group and Control Group
the students participated on the regular semester lecture
An organized simulation-focused training initiative utilizing standardized patients and bipolar disorder case studies to enable mental health nursing students to enhance their therapeutic communication, Empathy Self efficacy and nurse-patient engagement skills. The Experimental group were provided a structure simulation training with standardize patient scenarios guided by Jean Watson's Theory of Human Caring and features systematic simulation activities, interaction with standardized patients, supported debriefing sessions. while Control group has no simulation training only traditional curriculum lecture was given.
Therapeutic communication
Therapeutic communication, measured using the Therapeutic Communication Scale. The scale consists of 15 items, each rated on a 0-5 Likert-type scale. All items are scored in the same direction, with no reverse-scored items. Total scores range from 15 to 75, with higher scores indicating greater competence in therapeutic communication.
Time frame: Baseline and week 4 (end of intervention)
Empathy
Empathy, measured using the Empathy Assessment Scale. The scale consists of 13 items, each rated on a 1-5 Likert scale. All items are scored in the same direction, with no reverse-scored items. Total scores range from 13 to 65, with higher scores indicating greater empathy.
Time frame: Baseline and week 4 (end of intervention)
Self Efficacy
Self-efficacy, measured using the Self-Efficacy in Communication Scale (KSE-12). The scale consists of 12 items, each rated on a 1-5 Likert scale. All items are scored in the same direction, with no reverse-scored items. Total scores range from 12 to 60, with higher scores indicating greater communication self-efficacy.
Time frame: Baseline and week 4 (end of intervention)
Ran from May 2026 to primary completion in May 2026, 0 months.
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Near East University, Turkey