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Humanistic Approach-Based Caring Relationship Teaching in Nursing Students

25 de agosto de 2026 actualizado por: Aliye Yıldırım, Akdeniz University

The Effect of Individualized Caring Relationship Teaching Based on Paterson and Zderad's Humanistic Approach on Caring-Oriented Nurse-Patient Interaction: A Randomized Controlled Trial

This randomized controlled study aims to evaluate the effect of individualized caring relationship teaching based on Paterson and Zderad's Humanistic Nursing Approach on caring-oriented nurse-patient interaction among first-year nursing students before their first clinical practice.

Eligible nursing students will be randomly assigned to an intervention group or a control group using a computer-based randomization method. The intervention group will receive structured theoretical education based on Paterson and Zderad's Humanistic Nursing Approach, including individualized caring relationships, presence, reciprocity, meaningful interaction, the I-Thou relationship, and empathic communication. Following the theoretical education, students in the intervention group will participate in a structured simulation session with a standardized patient. The simulation will consist of prebriefing, scenario implementation, and debriefing.

Students in the control group will receive the conventional theoretical education included in the nursing curriculum and will not participate in the standardized-patient simulation.

Data will be collected before and after the intervention. Caring-oriented nurse-patient interaction will be assessed using a validated measurement instrument. In addition, students in the intervention group will be evaluated during the simulation using structured assessment tools, and their simulation experience and simulation-based learning will be assessed.

The study is expected to provide evidence regarding the effectiveness of combining humanistic nursing theory-based education with standardized-patient simulation in preparing nursing students for clinical practice and developing caring-oriented nurse-patient interaction.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This randomized controlled educational intervention study is designed to evaluate the effect of individualized caring relationship teaching based on Paterson and Zderad's Humanistic Nursing Approach on caring-oriented nurse-patient interaction among first-year nursing students before their first clinical practice.

Paterson and Zderad's Humanistic Nursing Approach conceptualizes nursing care as a reciprocal and meaningful relationship between two individuals. Within this approach, the nurse participates in the caring process not only through technical knowledge and skills but also through awareness of one's own presence and openness to the presence of another person. The approach emphasizes meaningful interaction, reciprocity, presence, individualized care, empathy, and the I-Thou relationship. In this study, these concepts will be incorporated into a structured educational intervention to support nursing students' preparation for clinical practice.

The study population will consist of first-year nursing students at Akdeniz University Faculty of Nursing who are preparing to begin clinical practice. Students who meet the eligibility criteria and voluntarily agree to participate will be included in the study. Participants will be randomly assigned to an intervention group or a control group using a computer-based randomization method following the pre-intervention assessment.

The intervention will consist of two main components. First, students in the intervention group will receive structured theoretical education based on Paterson and Zderad's Humanistic Nursing Approach. The educational content will include individualized caring relationships, presence, reciprocity, meaningful interaction, the I-Thou relationship, and empathic communication. The purpose of this education is to help students understand and apply the humanistic and relational dimensions of nursing care before entering the clinical setting.

Second, following the theoretical education, students in the intervention group will participate in a structured simulation session with a standardized patient. The simulation will be conducted in three stages: prebriefing, scenario implementation, and debriefing. During the prebriefing stage, the objectives of the simulation, participant roles, and principles of a safe learning environment will be explained. During the scenario, students will interact individually with the standardized patient and will be expected to establish a caring relationship, understand the patient's emotions and needs, use empathic communication, and develop an individualized approach to care. During the debriefing stage, students will participate in a reflective discussion facilitated by the educator. Their behaviors, strengths, areas for improvement, and learning outcomes will be discussed.

Students assigned to the control group will receive the conventional theoretical education included in the existing nursing curriculum, consisting of theoretical instruction and brief classroom discussions. No standardized-patient simulation or additional intervention will be provided to the control group. This design will allow the effects of the humanistic approach-based educational intervention combined with simulation to be compared with conventional theoretical education.

Data will be collected before and after the intervention. The Sociodemographic Information Form will be used to collect participants' sociodemographic characteristics. The Caring-Oriented Nurse-Patient Interaction Scale will be used to assess caring-oriented nurse-patient interaction. The Simulation Experience Satisfaction Scale and the Evaluation of Simulation-Based Learning Scale will be used to assess students' simulation experience and simulation-based learning, respectively. Simulation performance in the intervention group will additionally be evaluated using a structured performance assessment form.

The primary purpose of the intervention is to determine whether individualized caring relationship teaching based on Paterson and Zderad's Humanistic Nursing Approach, combined with structured standardized-patient simulation, improves caring-oriented nurse-patient interaction among nursing students compared with conventional theoretical education.

Quantitative data will be analyzed using the SPSS statistical software. Descriptive statistics, including mean, standard deviation, minimum and maximum values, frequencies, and percentages, will be calculated. Depending on the distribution of the data, paired-samples t-test or Wilcoxon signed-rank test will be used to evaluate within-group changes, while independent-samples t-test or Mann-Whitney U test will be used to compare differences between the intervention and control groups. Repeated-measures analysis of variance or appropriate non-parametric alternatives may be used to evaluate time and group effects when appropriate. Statistical significance will be accepted at p < 0.05.

The sample size will be determined using the G*Power program based on the expected effect size, statistical power, and significance level. The study protocol specifies a minimum of 90 students per group to provide adequate statistical power.

Participation in the study is not expected to involve any physical or clinical risk. Participation will be voluntary, written informed consent will be obtained from all participants, and personal information will be kept confidential. Simulation sessions will be conducted according to principles of a safe learning environment, and students' emotional comfort will be supported through the debriefing process.

The study is expected to contribute to nursing education by providing evidence on the educational applicability of Paterson and Zderad's Humanistic Nursing Approach and the use of standardized-patient simulation for developing caring-oriented nurse-patient interaction. The findings may provide a basis for integrating relationship-centered and humanistic approaches into preclinical nursing education and may support students' preparation for clinical practice.

Tipo de estudio

Intervencionista

Inscripción (Actual)

42

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.

Ubicaciones de estudio

      • Antalya, Turquía (Türkiye)
        • Akdeniz Üniversitesi Hemşirelik Fakültesi

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Being a first-year nursing student
  • Being scheduled to begin clinical practice for the first time
  • Being able to read and write in Turkish
  • Volunteering to participate in the study and providing written informed consent

Exclusion Criteria:

  • Not participating in the education or simulation session
  • Not completing the post-test measurements
  • Developing health-related or personal circumstances that negatively affect participation in the study

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: Standardized-Patient Simulation Group
Participants in this group received the conventional theoretical education included in the nursing curriculum followed by a structured standardized-patient simulation consisting of prebriefing, scenario implementation, and debriefing.
A structured simulation session with a standardized patient consisting of prebriefing, scenario implementation, and debriefing. During the simulation, students interacted individually with a standardized patient and practiced establishing a caring relationship, understanding the patient's emotions and needs, using empathic communication, and developing an individualized approach to care.
Sin intervención: Conventional Education Group
Participants in this group received the conventional theoretical education included in the nursing curriculum. The education consisted of theoretical instruction and brief classroom discussions. Participants in this group did not receive the standardized-patient simulation or any additional educational intervention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Caring-Oriented Nurse-Patient Interaction Scale Total Score
Periodo de tiempo: Baseline and immediately after the educational intervent
The level of caring-oriented nurse-patient interaction will be assessed using the Caring-Oriented Nurse-Patient Interaction Scale. The scale consists of 70 items rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The scale includes the dimensions of significance, competence, and applicability. All items are positively worded and there are no reverse-scored items. Higher total scores indicate higher levels of caring-oriented nurse-patient interaction behaviors.
Baseline and immediately after the educational intervent

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Simulation Experience Satisfaction Scale Total Score
Periodo de tiempo: Immediately after the simulation intervention
Satisfaction with the simulation-based educational experience will be assessed using the Simulation Experience Satisfaction Scale. The scale consists of 18 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). It includes three dimensions: debriefing and reflection, clinical reasoning, and clinical learning. There are no reverse-scored items. Higher scores indicate greater satisfaction with the simulation experience. Total and subscale scores will be evaluated.
Immediately after the simulation intervention
Simulation-Based Learning Evaluation Scale Total Score
Periodo de tiempo: Immediately after the simulation intervention
Simulation-based learning will be assessed using the Simulation-Based Learning Evaluation Scale. The scale consists of 37 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with a total score ranging from 37 to 185. The scale evaluates nursing process, patient safety, professional knowledge, communication, and reflective behaviors in the context of the simulation scenario. There are no reverse-scored items. Higher scores indicate greater achievement of the targeted competencies in the simulation scenario.
Immediately after the simulation intervention

Colaboradores e Investigadores

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

Patrocinador

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 (Actual)

28 de marzo de 2026

Finalización primaria (Actual)

28 de abril de 2026

Finalización del estudio (Actual)

8 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

11 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de agosto de 2026

Publicado por primera vez (Actual)

26 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de agosto de 2026

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

25 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • TBAEK-1168

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared with other researchers. The study data will be used for the purposes of the present research and reported in aggregate form to protect participant privacy and confidentiality.

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. .