HealthyNCT06176326
Program Development Study for Developing Ethical Decision Making and Ethical Sensitivity in Nursing Students
A study testing Ethics Education Program in Nursing in people with Healthy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this experimental study is to It is the development, implementation and evaluation of an ethics education program aimed at improving ethical decision making and ethical sensitivity in nursing students. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy
- What is being tested?
- Ethics Education Program in Nursing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2022to 10 Jun 2023
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Currently enrolled in a nursing undergraduate program
- Not having taken the Ethics in Nursing course as part of the student's academic program
- Willingness to voluntarily participate in the study
Who cannot join
- Having completed the Ethics in Nursing course as part of the academic program
- Not currently enrolled in a nursing undergraduate program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa Graduate Education Institute
Istanbul, Avcılar, 34000
About this study
The goal of this experimental study is to It is the development, implementation and evaluation of an ethics education program aimed at improving ethical decision making and ethical sensitivity in nursing students. The main questions it aims to answer are:
- Is the training program developed to develop ethical decision-making and ethical sensitivity in nursing students effective on students' ethical decision-making levels?
- Is the training program developed to develop ethical decision making and ethical sensitivity in nursing students effective on students' ethical sensitivity level?
Read more
The ındependent variable of the study is the developed education program, and the dependent variable is the students' ethical decision-making and ethical sensitivity levels.
Before the training program is applied to the participants, Ethical Sensitivity Scale Adapted to Nursing Students, Ethical Dilemma Test in Nursing, Preliminary Knowledge Test and Information Forms will be applied. During the implementation of the program, educator diaries and student diaries will be evaluated to evaluate the implementation process. At the end of the program implementation, the program will be evaluated. For evaluation purposes, the Curriculum Evaluation Form will be applied. In addition, Ethical Sensitivity Scale Adapted to Nursing Students and Ethical Dilemma Test in Nursing post-tests will be applied.
Read the detailed description
The program development study will commence with a needs analysis, employing a democratic approach during the needs analysis process. An analysis of existing documents related to ethical education in nursing will be conducted. Studies on the current status and trends of ethical education in nursing in Turkey and worldwide, expert opinions, and a review of international and national documents will be examined to determine the direction of existing efforts. The Taba-Tyler program development model is planned for use in developing the education program. Based on the data obtained from the needs analysis, the education program will be prepared. Following the preparation of the Ethics Education Program, the population of the study consisting of second-year nursing students will be administered the Adapted Ethical Sensitivity Scale for Nursing Students, Nursing Ethical Dilemma Test, and Information Forms. Students who agree to participate will be informed about the research, and their consent will be obtained.
Thirty-four students who agreed to participate were included in the Nursing Ethics Education Program. They attended a 7-session training program, with each session lasting an average of 2 hours. At the conclusion of this training program, an evaluation of the program was conducted, and the second set of data was collected using the same data collection tools. Following a 1-month follow-up period and a 3-month follow-up period, the Adapted Ethical Sensitivity Scale for Nursing Students and the Nursing Ethical Dilemma Test were administered again to complete continuous measurements.
- Conditions
- Healthy
- Being tested
- Ethics Education Program in Nursing
- Keywords
- Ethics education, Nursing students,, Ethics, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethics Education Program in NursingOther
In the 7-session training program, each session, lasting 2 hours, presented to students the topic headings determined through the needs analysis of the program development study. This education program consists of sessions on the Introduction to Ethics-Bioethics, Principles of Beneficence and Non-maleficence, Autonomy and Responsibility, Informed Consent and Those Lacking Capacity for Consent, Respect for Human Vulnerability and Individual Integrity, Respect for Private Life and Ensuring Confidentiality, Discrimination, Stigmatization, and Cultural Diversity.
| Study group | Role | What they receive |
|---|---|---|
| Implementation of the Developed Ethics Education Program | Experimental | The developed education program will be implemented as a 7 week-2 hour session. Receives: Other: Ethics Education Program in Nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Total Score of the Ethical Sensitivity Scale Adapted for Nursing Students (ESSNS)
ESSNS the statement is scored on a scale from 1 point (Strongly disagree) to 7 points (Strongly agree). The total score can range from 30 to 210. A high score indicates high ethical sensitivity, while a low score indicates low ethical sensitivity.
Change=(Before the education, immediately after the education, one month after the education, three months after the education).
Measured: Before the education, immediately after the education, one month after the education, three months after the education
Change from Nursing Ethical Dilemma Test Scale "Practical Thinking" Subscale
The statement includes a six-item expression that students can consider regarding their approach to the moral dilemma scenario indicated on the scale. Students are expected to choose the most important among these statements and prioritize them according to their importance. Based on the responses given to this section of the test, the aim is to determine the students' level of "Practical Thinking (PD) [Practical Considerations= PC]." The minimum achievable PD score on the test is 6, and the maximum PD score is 36.
Change=(Before the education, immediately after the education, one month after the education, three months after the education).
Measured: Before the education, immediately after the education, one month after the education, three months after the education
Change from Nursing Ethical Dilemma Test Scale "Principle Thinking" Subscale
Students are presented with a six-item statement reflecting their approach to the moral dilemma scenario indicated on the scale. They are expected to choose the most important among these statements and prioritize them according to their own perceived importance. The purpose of this section of the test is to determine the students' level of "Principled Thinking (PT) [Nursing Principled Thinking= NP]." The minimum achievable PT score on the test is 18, and the maximum is 66, based on the responses given in this section.
Change=(Before the education, immediately after the education, one month after the education, three months after the education).
Measured: Before the education, immediately after the education, one month after the education, three months after the education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start20 Dec 2022
- Primary completion27 Jan 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- One-group Pretest-Posttest Experimental Method
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Sezer, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176326
- Sponsor's protocol ID
- HemsirelikOgrencilerindeEtik
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program Development Study for Developing Ethical Decision Making and Ethical Sensitivity in Nursing Students
- ClinicalTrials.gov ID
- NCT06176326
- Acronym / sponsor ID
- HemsirelikOgrencilerindeEtik
- Conditions
- Healthy
- Keywords
- Ethics education, Nursing students,, Ethics, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 19 Dec 2023 (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.
The goal of this experimental study is to It is the development, implementation and evaluation of an ethics education program aimed at improving ethical decision making and ethical sensitivity in nursing students. The main questions it aims to answer are:
- Is the training program developed to develop ethical decision-making and ethical sensitivity in nursing students effective on students' ethical decision-making levels?
- Is the training program developed to develop ethical decision making and ethical sensitivity in nursing students effective on students' ethical sensitivity level?
The ındependent variable of the study is the developed education program, and the dependent variable is the students' ethical decision-making and ethical sensitivity levels.
Before the training program is applied to the participants, Ethical Sensitivity Scale Adapted to Nursing Students, Ethical Dilemma Test in Nursing, Preliminary Knowledge Test and Information Forms will be applied. During the implementation of the program, educator diaries and student diaries will be evaluated to evaluate the implementation process. At the end of the program implementation, the program will be evaluated. For evaluation purposes, the Curriculum Evaluation Form will be applied. In addition, Ethical Sensitivity Scale Adapted to Nursing Students and Ethical Dilemma Test in Nursing post-tests will be applied.
Detailed description
The program development study will commence with a needs analysis, employing a democratic approach during the needs analysis process. An analysis of existing documents related to ethical education in nursing will be conducted. Studies on the current status and trends of ethical education in nursing in Turkey and worldwide, expert opinions, and a review of international and national documents will be examined to determine the direction of existing efforts. The Taba-Tyler program development model is planned for use in developing the education program. Based on the data obtained from the needs analysis, the education program will be prepared. Following the preparation of the Ethics Education Program, the population of the study consisting of second-year nursing students will be administered the Adapted Ethical Sensitivity Scale for Nursing Students, Nursing Ethical Dilemma Test, and Information Forms. Students who agree to participate will be informed about the research, and their consent will be obtained.
Thirty-four students who agreed to participate were included in the Nursing Ethics Education Program. They attended a 7-session training program, with each session lasting an average of 2 hours. At the conclusion of this training program, an evaluation of the program was conducted, and the second set of data was collected using the same data collection tools. Following a 1-month follow-up period and a 3-month follow-up period, the Adapted Ethical Sensitivity Scale for Nursing Students and the Nursing Ethical Dilemma Test were administered again to complete continuous measurements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One-group Pretest-Posttest Experimental Method
| Arm | Type | Receives |
|---|---|---|
| Implementation of the Developed Ethics Education Program | Experimental | Other: Ethics Education Program in NursingThe developed education program will be implemented as a 7 week-2 hour session. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Currently enrolled in a nursing undergraduate program
- Not having taken the Ethics in Nursing course as part of the student's academic program
- Willingness to voluntarily participate in the study
Key exclusion criteria (2 listed)
- Having completed the Ethics in Nursing course as part of the academic program
- Not currently enrolled in a nursing undergraduate program
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 |
|---|---|---|
| Ethics Education Program in NursingIn the 7-session training program, each session, lasting 2 hours, presented to students the topic headings determined through the needs analysis of the program development study. This education program consists of sessions on the Introduction to Ethics-Bioethics, Principles of Beneficence and Non-maleficence, Autonomy and Responsibility, Informed Consent and Those Lacking Capacity for Consent, Respect for Human Vulnerability and Individual Integrity, Respect for Private Life and Ensuring Confidentiality, Discrimination, Stigmatization, and Cultural Diversity. | Other | Implementation of the Developed Ethics Education Program |
Primary outcome
Change from Total Score of the Ethical Sensitivity Scale Adapted for Nursing Students (ESSNS)
Time frame: Before the education, immediately after the education, one month after the education, three months after the education
ESSNS the statement is scored on a scale from 1 point (Strongly disagree) to 7 points (Strongly agree). The total score can range from 30 to 210. A high score indicates high ethical sensitivity, while a low score indicates low ethical sensitivity. Change=(Before the education, immediately after the education, one month after the education, three months after the education).
Change from Nursing Ethical Dilemma Test Scale "Practical Thinking" Subscale
Time frame: Before the education, immediately after the education, one month after the education, three months after the education
The statement includes a six-item expression that students can consider regarding their approach to the moral dilemma scenario indicated on the scale. Students are expected to choose the most important among these statements and prioritize them according to their importance. Based on the responses given to this section of the test, the aim is to determine the students' level of "Practical Thinking (PD) [Practical Considerations= PC]." The minimum achievable PD score on the test is 6, and the maximum PD score is 36. Change=(Before the education, immediately after the education, one month after the education, three months after the education).
Change from Nursing Ethical Dilemma Test Scale "Principle Thinking" Subscale
Time frame: Before the education, immediately after the education, one month after the education, three months after the education
Students are presented with a six-item statement reflecting their approach to the moral dilemma scenario indicated on the scale. They are expected to choose the most important among these statements and prioritize them according to their own perceived importance. The purpose of this section of the test is to determine the students' level of "Principled Thinking (PT) [Nursing Principled Thinking= NP]." The minimum achievable PT score on the test is 18, and the maximum is 66, based on the responses given in this section. Change=(Before the education, immediately after the education, one month after the education, three months after the education).
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 19 Dec 2023.
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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 Ethics Education Program in Nursing in people with Healthy, run by Istanbul University - Cerrahpasa 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 3 inclusion and 2 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 19 Dec 2023. 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?
Change from Total Score of the Ethical Sensitivity Scale Adapted for Nursing Students (ESSNS) (time frame: Before the education, immediately after the education, one month after the education, three months after the education). The study lists 3 primary outcomes in all. 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 19 Dec 2023.