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NCT Number: NCT07760389

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joy Johnson Agbo

Nicosia, Lefkosa, 99040, Cyprus

About this study

### 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Therapeutic communication

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

    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.

Secondary outcomes

  1. Empathy

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

    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.

  2. Self Efficacy

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

    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.

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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