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AzTrials

EmpathyGENENCT07834541

Sensory Restriction Simulation Training for Nursing Student Empathy and Communication

A study testing GENE Sensory Restriction Simulation Training and Standard Theoretical Empathy Education in people with Empathy, run by Volkan Gokmen at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Empathy
What is being tested?
GENE Sensory Restriction Simulation Training and Standard Theoretical Empathy Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
Oct 2026to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Declining to provide informed consent
  • Not currently enrolled as a third-year nursing student in the Nursing Department of Agri Ibrahim Cecen University

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Volkan Gokmen, PhD contact

+90 532 739 0938

vgokmen@agri.edu.tr

Turkey (Türkiye)1 site
  • Agri Ibrahim Cecen University Faculty of Health Sciences

    Ağrı

    Burcu Demir Gokmen, PhD, +90 506 751 6888, vgokmen@agri.edu.tr

    Volkan Gokmen, PhD

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Empathy
Being tested
GENE Sensory Restriction Simulation Training, Standard Theoretical Empathy Education
Keywords
Nursing Education, Simulation Training, Sensory Restriction Simulation, Communication Skills, Patient-Centered Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GENE Sensory Restriction Simulation TrainingBehavioural

    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.

  • Standard Theoretical Empathy EducationBehavioural

    Standard classroom-based theoretical education on empathy and patient-centered care, without the GENE sensory restriction simulation component.

Study groups in NCT07834541
Study groupRoleWhat they receive
GENE Sensory Restriction Simulation GroupExperimentalParticipants 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.
Receives: Behavioral: GENE Sensory Restriction Simulation Training
Control GroupActive comparatorParticipants receive standard theoretical education on empathy and patient-centered care, without the GENE sensory restriction simulation component.
Receives: Behavioral: Standard Theoretical Empathy Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Empathy Level (JSE-NS)

    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.

    Measured: Baseline (immediately before the session) and immediately after the session (same day)

Secondary outcomes (4)
  1. Change in Communication Skills

    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.

    Measured: Baseline (immediately before the session) and immediately after the session (same day)

  2. Change in Patience

    Change in patience from before to immediately after the session, measured with the Turkish version of the Patience Scale. Higher scores indicate greater patience.

    Measured: Baseline (immediately before the session) and immediately after the session (same day)

  3. Change in Psychological Resilience

    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.

    Measured: Baseline (immediately before the session) and immediately after the session (same day)

  4. Change in Patient-Centered Care Competency (HMBY)

    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.

    Measured: Baseline (immediately before the session) and immediately after the session (same day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07834541
Sponsor's protocol ID
AICU-GENE-2026
Other IDs
TUBITAK 2209-A (2025 Cycle)
Acronym
GENE
Status last verified
Sep 2026
First submitted
16 Sep 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34431189
  • 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.

    PubMed 36411407
  • 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.

    PubMed 33743185
  • 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.

    PubMed 29068733
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing GENE Sensory Restriction Simulation Training and Standard Theoretical Empathy Education in people with Empathy, run by Volkan Gokmen at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Volkan Gokmen, PhD (+90 532 739 0938, vgokmen@agri.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Empathy Level (JSE-NS) (time frame: Baseline (immediately before the session) and immediately after the session (same day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07834541, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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