Humanistic Approach-Based Caring Relationship Teaching in Nursing Students
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
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2026
CompletedFirst Submitted
Initial submission to the registry
August 11, 2026
CompletedFirst Posted
Study publicly available on registry
August 26, 2026
CompletedAugust 26, 2026
August 1, 2026
1 month
August 11, 2026
August 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caring-Oriented Nurse-Patient Interaction Scale Total Score
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
Secondary Outcomes (2)
Simulation Experience Satisfaction Scale Total Score
Immediately after the simulation intervention
Simulation-Based Learning Evaluation Scale Total Score
Immediately after the simulation intervention
Study Arms (2)
Standardized-Patient Simulation Group
EXPERIMENTALParticipants 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.
Conventional Education Group
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akdeniz Üniversitesi Hemşirelik Fakültesi
Antalya, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 11, 2026
First Posted
August 26, 2026
Study Start
March 28, 2026
Primary Completion
April 28, 2026
Study Completion
May 8, 2026
Last Updated
August 26, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
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.