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Humanistic Approach-Based Caring Relationship Teaching in Nursing Students

25 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

42

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Caring-Oriented Nurse-Patient Interaction Scale Total Score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Simulation Experience Satisfaction Scale Total Score
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 marzo 2026

Completamento primario (Effettivo)

28 aprile 2026

Completamento dello studio (Effettivo)

8 maggio 2026

Date di iscrizione allo studio

Primo inviato

11 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 agosto 2026

Primo Inserito (Effettivo)

26 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • TBAEK-1168

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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