NCT07786948

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

August 11, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Humanistic NursingPaterson and Zderad's Humanistic Nursing ApproachCaring RelationshipNurse-Patient Interaction

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

EXPERIMENTAL

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.

Behavioral: Standardized-Patient Simulation Group

Conventional Education Group

NO INTERVENTION

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.

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.

Standardized-Patient Simulation Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two parallel groups will be compared. Participants will be randomly assigned to an intervention group receiving humanistic approach-based theoretical education followed by standardized-patient simulation or a control group receiving conventional theoretical education.
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.

Locations