- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07834541
Sensory Restriction Simulation Training for Nursing Student Empathy and Communication (GENE)
The Effect of the Reality-Integrated Quality Education (GENE) Approach With Sensory Restriction Simulations on Nursing Students' Empathy, Communication, and Patient-Centered Care Skills
This study evaluates the effect of the Reality-Integrated Quality Education (GENE) approach, an educational intervention using sensory restriction simulations (vision, hearing, speech, and movement restriction), on empathy, communication skills, patience, psychological resilience, and patient-centered care competency among third-year nursing students. Sixty nursing students will be randomly allocated to an experimental group (n=30), who will complete a single 30-45 minute GENE simulation session, or a control group (n=30), who will receive standard theoretical empathy education without the simulation component. Outcomes will be assessed immediately before and after the session using the Turkish versions of the Jefferson Scale of Empathy - Nursing Student (JSE-NS), a Communication Skills Inventory, a Patience Scale, the Brief Resilience Scale, and a Patient-Centered Care Competency Scale. The investigators hypothesize that participation in the GENE sensory restriction simulations will produce greater short-term gains in empathy, communication, patience, resilience, and patient-centered care competency than theoretical education alone.
Study Overview
Status
Conditions
Detailed Description
Empathy, effective communication, and patient-centered care are core competencies for nursing practice, and are traditionally taught through classroom-based theoretical instruction. Sensory restriction simulation is proposed as an experiential teaching strategy in which learners temporarily experience a restriction analogous to a patient's sensory or functional limitation, with the aim of building experiential understanding rather than only conceptual knowledge.
This study uses a quasi-experimental, randomized, pretest-posttest, parallel-group design to evaluate the Reality-Integrated Quality Education (GENE) approach in a single center: the Nursing Department of Agri Ibrahim Cecen University. A pool of 60 third-year nursing students will be randomly allocated to an experimental group (n=30) or a control group (n=30).
The experimental group will complete the GENE model, a four-stage sensory restriction simulation sequence lasting approximately 30-45 minutes in total, comprising sequential simulated restriction of vision, hearing, speech, and movement, each paired with simulated patient-care tasks and structured post-simulation debriefing and feedback (recorded via a post-simulation feedback form). The control group will receive standard theoretical education on empathy and patient-centered care without the simulation component. This is an educational/behavioral intervention rather than a drug, biologic, or device intervention; the study's primary purpose is therefore classified as "Other" (educational intervention effectiveness) rather than treatment, prevention, diagnostic, or supportive care.
Primary and secondary outcomes are assessed once before and once after the session (same day) using the following instruments, all administered in their validated Turkish-language versions: the Jefferson Scale of Empathy - Nursing Student (JSE-NS) for empathy; a Communication Skills Inventory; a Patience Scale; the Brief Resilience Scale; and a Patient-Centered Care Competency Scale (HMBY). An application/intake form (Participant Introduction Form) is used to record participant demographic and background characteristics before randomization.
Planned statistical analysis will use Statistical Package for the Social Sciences (SPSS, version 29). Normality of distributions will be assessed with the Shapiro-Wilk test. Depending on distributional assumptions, within-group pre-post changes and between-group (experimental vs. control) comparisons will be analyzed using repeated-measures analysis of variance (ANOVA) or, for non-normally distributed data, the Wilcoxon signed-rank test and Mann-Whitney U test, with Bonferroni correction applied for multiple comparisons. Effect sizes will be calculated and reported alongside p-values.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Volkan Gokmen, PhD
- Phone Number: +90 532 739 0938
- Email: vgokmen@agri.edu.tr
Study Locations
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Ağrı, Turkey (Türkiye)
- Agri Ibrahim Cecen University Faculty of Health Sciences
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Contact:
- Burcu Demir Gokmen, PhD
- Phone Number: +90 506 751 6888
- Email: vgokmen@agri.edu.tr
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Principal Investigator:
- Volkan Gokmen, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Currently enrolled as a third-year nursing student in the Nursing Department of Agri Ibrahim Cecen University
- Voluntary agreement to participate and provide informed consent
Exclusion Criteria:
- Declining to provide informed consent
- Not currently enrolled as a third-year nursing student in the Nursing Department of Agri Ibrahim Cecen University
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GENE Sensory Restriction Simulation Group
Participants complete the GENE model: a single 30-45 minute sequence of four sequential sensory restriction simulations (vision, hearing, speech, and movement restriction), each paired with simulated patient-care tasks, followed by structured debriefing and feedback. |
A single 30-45 minute educational simulation session consisting of four sequential sensory restriction stages (vision, hearing, speech, and movement restriction), each combined with simulated patient-care tasks, followed by structured debriefing and feedback using a post-simulation feedback form. |
|
Active Comparator: Control Group
Participants receive standard theoretical education on empathy and patient-centered care, without the GENE sensory restriction simulation component. |
Standard classroom-based theoretical education on empathy and patient-centered care, without the GENE sensory restriction simulation component. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Empathy Level (JSE-NS)
Time Frame: Baseline (immediately before the session) and immediately after the session (same day)
|
Change in empathy from before to immediately after the session, measured with the Turkish version of the Jefferson Scale of Empathy - Nursing Student (JSE-NS). Higher scores indicate greater empathy. |
Baseline (immediately before the session) and immediately after the session (same day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Communication Skills
Time Frame: Baseline (immediately before the session) and immediately after the session (same day)
|
Change in communication skills from before to immediately after the session, measured with the Turkish version of the Communication Skills Inventory. Higher scores indicate better communication skills. |
Baseline (immediately before the session) and immediately after the session (same day)
|
|
Change in Patience
Time Frame: Baseline (immediately before the session) and immediately after the session (same day)
|
Change in patience from before to immediately after the session, measured with the Turkish version of the Patience Scale. Higher scores indicate greater patience. |
Baseline (immediately before the session) and immediately after the session (same day)
|
|
Change in Psychological Resilience
Time Frame: Baseline (immediately before the session) and immediately after the session (same day)
|
Change in psychological resilience from before to immediately after the session, measured with the Turkish version of the Brief Resilience Scale. Higher scores indicate greater resilience. |
Baseline (immediately before the session) and immediately after the session (same day)
|
|
Change in Patient-Centered Care Competency (HMBY)
Time Frame: Baseline (immediately before the session) and immediately after the session (same day)
|
Change in patient-centered care competency from before to immediately after the session, measured with the Patient-Centered Care Competency Scale (HMBY). Higher scores indicate greater competency. |
Baseline (immediately before the session) and immediately after the session (same day)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Volkan Gokmen, PhD, Agri Ibrahim Cecen University
Publications and helpful links
General Publications
- Macaden L, Smith A, Croy S. Simulation on sensory impairment in older adults: nursing education. Br J Nurs. 2017 Oct 26;26(19):1057-1064. doi: 10.12968/bjon.2017.26.19.1057.
- Tong, L. K., Chan, S., & Leung, J. (2024). Effects of simulation-based education on communication, empathy and clinical skills: A multicenter randomized controlled trial. Journal of Nursing Education, 63(4), 210-223.
- Arslanoğlu, A., & Kırılmaz, H. (2019). Hasta merkezli bakım yetkinliği (HMBY) ölçeğinin Türkçe'ye uyarlanması. Sağlık Akademisyenleri Dergisi, 6(2), 158-166.
- Doğan, T. (2015). Adaptation of the Brief Resilience Scale into Turkish: A validity and reliability study. The Journal of Happiness & Well-Being, 5, 93-102.
- Eliüşük, A., & Arslan, C. (2016). Sabır ölçeğinin Türkçe'ye uyarlanması: Geçerlilik ve güvenirlik çalışmaları. Değerler Eğitimi Dergisi.
- Ersanlı, K., & Balcı, S. (1998). İletişim becerileri envanterinin geliştirilmesi: Geçerlik ve güvenirlik çalışması. Türk Psikolojik Danışma ve Rehberlik Dergisi, 2(10), 7-12.
- Yanık, A., & Saygılı, S. (2014). Validity and reliability of the Turkish version of Jefferson Scale of Empathy for nursing students. Türkiye Klinikleri Journal of Medical Sciences, 34(1), 111-119. https://doi.org/10.5336/medsci.2013-37793
- Perry, A. G., Potter, P. A., & Ostendorf, W. R. (2022). Sensory impairments. In Nursing Fundamentals. NCBI Bookshelf.
- Aryuwat, P., Suwanno, J., & Cummings, E. (2022). An integrative review of resilience among nursing students. International Journal of Nursing Studies, 130, 104115.
- Aoki Y, Katayama H. Development of the Clinical Interpersonal Reactivity Index to evaluate nurses' empathy. Nurs Health Sci. 2021 Dec;23(4):862-870. doi: 10.1111/nhs.12875. Epub 2021 Sep 15.
- Abdelnasser N, Abdel Aziz SAE, El-Gamal SMA. Effect of nursing guidelines on first-year nursing students' knowledge and reported practice towards sensory impairments among the elderly. BMC Geriatr. 2022 Nov 21;22(1):883. doi: 10.1186/s12877-022-03524-3.
- Kiegaldie, D., Hauck, Y., & Chang, S. (2023). Virtual reality simulation for nursing education: A scoping review. Simulation in Healthcare, 18(2), 121-135.
- Yu J, Parsons GS, Lancastle D, Tonkin ET, Ganesh S. "Walking in Their Shoes": The effects of an immersive digital story intervention on empathy in nursing students. Nurs Open. 2021 Sep;8(5):2813-2823. doi: 10.1002/nop2.860. Epub 2021 Mar 20.
- Stjernetun, B. B., Hovland, M. S., & Kristoffersen, M. (2024). "It's like walking in a bubble": Nursing students' perspectives on sensory-impairment simulation suits. BMC Nursing, 23(1), 147.
- Ferri, P., Giorgi, F., Lecca, L. I., Agostinis, A., & Arcangeli, G. (2019). Impact of expert-patient teaching on empathy in nursing students. Nurse Education Today, 76, 104-110.
- Cho MK, Kim MY. Effectiveness of simulation-based interventions on empathy enhancement among nursing students: a systematic literature review and meta-analysis. BMC Nurs. 2024 May 11;23(1):319. doi: 10.1186/s12912-024-01944-7.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AICU-GENE-2026
- TUBITAK 2209-A (2025 Cycle) (Other Grant/Funding Number: The Scientific and Technological Research Council of Turkey (TUBITAK))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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