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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Nursing Education
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted26 Aug 2026
- Study start28 Mar 2026
- Primary completion28 Apr 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliye Yıldırım, Akdeniz University
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07786948
- Acronym / sponsor ID
- TBAEK-1168
- Conditions
- Nursing Education
- Keywords
- Humanistic Nursing, Paterson and Zderad's Humanistic Nursing Approach, Caring Relationship, Nurse-Patient Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 28 Mar 2026 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standardized-Patient Simulation Group | Experimental | Behavioral: Standardized-Patient Simulation GroupParticipants 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 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized-Patient Simulation GroupA 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. | Behavioural | Standardized-Patient Simulation Group |
Primary outcome
Caring-Oriented Nurse-Patient Interaction Scale Total Score
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.
2 secondary outcomes
Simulation Experience Satisfaction Scale Total Score
Time frame: Immediately after the simulation intervention
Simulation-Based Learning Evaluation Scale Total Score
Time frame: Immediately after the simulation intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.