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Sensory Restriction Simulation Training for Nursing Student Empathy and Communication (GENE)

21 de septiembre de 2026 actualizado por: Volkan Gokmen

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Volkan Gokmen, PhD
  • Número de teléfono: +90 532 739 0938
  • Correo electrónico: vgokmen@agri.edu.tr

Ubicaciones de estudio

      • Ağrı, Turquía (Türkiye)
        • Agri Ibrahim Cecen University Faculty of Health Sciences
        • Contacto:
          • Burcu Demir Gokmen, PhD
          • Número de teléfono: +90 506 751 6888
          • Correo electrónico: vgokmen@agri.edu.tr
        • Investigador principal:
          • Volkan Gokmen, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Empathy Level (JSE-NS)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Communication Skills
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Volkan Gokmen, PhD, Agri Ibrahim Cecen University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

16 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de septiembre de 2026

Publicado por primera vez (Actual)

22 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • AICU-GENE-2026
  • TUBITAK 2209-A (2025 Cycle) (Otro número de subvención/financiamiento: The Scientific and Technological Research Council of Turkey (TUBITAK))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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