Impact of Simulation-Based Intervention on Empathy, Communication, and Self-Efficacy Among Mental Health Nursing Students

NCT07760389 | Completed DMC

• 2 other identifiers: NearEastUJoy Johnson Agbo
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Simulation-Based Learning in Mental Health Nursing

Outcome Measures

Primary Outcomes (1)

• Therapeutic communication

  Therapeutic communication, measured using the Therapeutic Communication Scale. The scale consists of 16 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 16 to 80, with higher scores indicating greater competence in therapeutic communication.

  Baseline and week 4 (end of intervention)

Secondary Outcomes (2)

• Empathy

  Baseline and week 4 (end of intervention)

• Self Efficacy

  Baseline and week 4 (end of intervention)

Study Arms (2)

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

Behavioral: Experimental Group and Control Group

Control group

NO INTERVENTION

the students participated on the regular semester lecture

Interventions

Experimental Group and Control Group BEHAVIORAL

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.

Simulation based education

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Joy Johnson Agbo

Nicosia, Lefkosa, 99040, Cyprus

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• JOY J. AGBO, PhD Student

  Near East University, Nursing Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The simulation teaching is given to the students' participant group

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: August 12, 2026
• Study Start: May 1, 2026
• Primary Completion: May 22, 2026
• Study Completion: May 29, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

CY (1)