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Clinical Trials/NCT07760389
NCT07760389CompletedNot Applicable

Evaluating The Impact of A Simulation-Based Intervention on Empathy, Therapeutic Communication, And Self-Efficacy Among Mental Health Nursing Students: Guided by Jean Watson Theory

Near East University, Turkey1 site in 1 country70 target enrollmentStarted: May 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Therapeutic communication

Study Overview

Brief Summary

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

### 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

The outcome assessor will be blinded to participants' group allocation and will not be involved in participant recruitment, randomization, or delivery of the intervention. Participants and intervention facilitators will not be blinded because of the nature of the educational intervention.

Eligibility Criteria

Ages
18 Years to 27 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Were officially and early registered in the mental health nursing course
  • •Provided informed consent to participate
  • •Were available throughout the duration of the intervention

Exclusion Criteria

  • •Declined to participate
  • •Were absent during key phases of the intervention
  • •Did not complete the required data collection instruments.
  • •Late registration

Arms & Interventions

Control group

No Intervention

the students participated on the regular semester lecture

Simulation based education

Experimental

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

Intervention: Experimental Group and Control Group (Behavioral)

Outcomes

Primary Outcomes

Therapeutic communication

Time Frame: Baseline and week 4 (end of intervention)

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.

Secondary Outcomes

  • Empathy(Baseline and week 4 (end of intervention))
  • Self Efficacy(Baseline and week 4 (end of intervention))

Investigators

Sponsor
Near East University, Turkey
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joy Johnson Agbo

Principal Investigator

Near East University, Turkey

Study Sites (1)

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