Akdeniz Üniversitesi Hemşirelik Fakültesi
Antalya, Turkey (Türkiye)
NCT Number: NCT07786948
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Antalya, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Akdeniz University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07521917
Awareness, Child Abuse
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07796009
Attitude, Behavior
Istanbul, Usküdar, Turkey (Türkiye)
View Trial DetailsNCT07789652
Neoplasms, Nursing Care
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07773844
First Aid, Hemorrhage
Izmir, Turkey (Türkiye)
View Trial Details