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

NCT07760389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-12

No results posted yet for this study

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

Interventions

BEHAVIORAL

Experimental Group and Control Group

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.

Sponsors & Collaborators

  • Near East University, Turkey

    lead OTHER

Principal Investigators

  • JOY J. AGBO, PhD Student · Near East University, Nursing Department

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
27 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-05-22
Completion
2026-05-29

Countries

  • Cyprus

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760389 on ClinicalTrials.gov