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Nursing EducationNCT07786948

Humanistic Approach-Based Caring Relationship Teaching in Nursing Students

A study testing Standardized-Patient Simulation Group in people with Nursing Education, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Nursing Education
What is being tested?
Standardized-Patient Simulation Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Mar 2026to 8 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Akdeniz Üniversitesi Hemşirelik Fakültesi

    Antalya

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Standardized-Patient Simulation Group
Keywords
Humanistic Nursing, Paterson and Zderad's Humanistic Nursing Approach, Caring Relationship, Nurse-Patient Interaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardized-Patient Simulation GroupBehavioural

    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.

Study groups in NCT07786948
Study groupRoleWhat they receive
Standardized-Patient Simulation GroupExperimentalParticipants 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.
Receives: Behavioral: Standardized-Patient Simulation Group
Conventional Education GroupNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and immediately after the educational intervent

Secondary outcomes (2)
  1. Simulation Experience Satisfaction Scale Total Score

    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.

    Measured: Immediately after the simulation intervention

  2. Simulation-Based Learning Evaluation Scale Total Score

    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.

    Measured: Immediately after the simulation intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2026
  2. Study start28 Mar 2026
  3. Primary completion28 Apr 2026
  4. Study completion8 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07786948
Sponsor's protocol ID
TBAEK-1168
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Standardized-Patient Simulation Group in people with Nursing Education, run by Akdeniz University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caring-Oriented Nurse-Patient Interaction Scale Total Score (time frame: Baseline and immediately after the educational intervent). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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