Program Development Study for Developing Ethical Decision Making and Ethical Sensitivity in Nursing Students

December 10, 2023 updated by: Esra Sezer, Istanbul University - Cerrahpasa (IUC)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Avcılar
      • Istanbul, Avcılar, Turkey, 34000
        • Istanbul University-Cerrahpasa Graduate Education Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Having completed the Ethics in Nursing course as part of the academic program
  • Not currently enrolled in a nursing undergraduate program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Implementation of the Developed Ethics Education Program
The developed education program will be implemented as a 7 week-2 hour session.
Other: Ethics Education Program in Nursing
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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).
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).
Before the education, immediately after the education, one month after the education, three months after the education

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HemsirelikOgrencilerindeEtik

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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