Protocol summary

Study aim
Determining the impact of education based on ethical concepts scenario on the professional moral courage of nursing students
Design
A controlled, single-blind, randomized clinical trial was conducted with 24 students in each group. Simple randomization was employed using coin tossing for the randomization process.
Settings and conduct
This study is of a quasi-experimental design. The research setting includes the School of Nursing at Tehran University of Medical Sciences. The study population will consist of all undergraduate nursing students at this university. For the experimental group, a workshop on the concepts of ethics will be held. This group will receive the ethics concepts training program in the form of a single 4-hour workshop. This study is single-blind.
Participants/Inclusion and exclusion criteria
**Study Population:** Undergraduate nursing students of this university. **Inclusion Criteria:** - Willingness to participate in the study. - Successful completion of the theoretical course in professional ethics. - Having at least one year of clinical experience as a student. - No addiction or use of psychiatric medications. - No history of diagnosed psychological disorders. **Exclusion Criteria:** - Failure to attend the training workshop. - Incomplete filling of more than 10% of the questionnaire.
Intervention groups
For the test group, a single 4-hour workshop on medical ethics will be conducted, covering the principles of benefit, non-harm, justice, autonomy, confidentiality, truthfulness, and disclosure. Students will discuss and critique scenarios from an ethical perspective. Educational materials, including scenarios and videos, will be provided via a Telegram group to reinforce the training until the end of the intervention.
Main outcome variables
Professional Moral Courage of Nursing Students

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240319061338N1
Registration date: 2024-07-31, 1403/05/10
Registration timing: prospective

Last update: 2024-07-31, 1403/05/10
Update count: 0
Registration date
2024-07-31, 1403/05/10
Registrant information
Name
Ali Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3233 0742
Email address
aliakbari.1379110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of Scenario-Based moral Concepts Training on the Professional Moral Courage of Nursing Students
Public title
Impact of Scenario-Based Moral Concepts Training on The Moral Courage
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having the willingness to participate in the study Successful completion of the theoretical course in professional ethics Having at least one year of clinical experience as a student No addiction or use of psychiatric medications No history of diagnosed psychological disorders
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of classes to either the test group or the control group will be conducted using simple randomization through a coin flip. One of the study groups will be assigned heads and the other tails, and the coin will be flipped for each class. Based on the outcome of the coin flip, students will be randomly assigned to one of the two groups. Accordingly, all nursing students of the 68th cohort at Tehran University of Medical Sciences who meet the inclusion criteria will be divided into test and control groups (one class for the test group and one class for the control group) after obtaining informed consent (as provided in the appendices).
Blinding (investigator's opinion)
Single blinded
Blinding description
The training workshop for the test group is held at separate times and places, and the educational materials are presented to them in a natural and non-obvious manner. Pre- and post-intervention evaluation questionnaires are collected online and face-to-face without the participants being aware of the specific intervention, thus reducing psychological effects and biases related to group knowledge.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Room 604, 6th Floor, Central Building, Tehran University of Medical Sciences Intersection of Qods Street, Keshavarz Boulevard Office of the Ethics Committee for Biomedical Research, University of Tehran
City
Tehran
Province
Tehran
Postal code
1417994575
Approval date
2024-03-17, 1402/12/27
Ethics committee reference number
IR.TUMS.FNM.REC.1402.249

Health conditions studied

1

Description of health condition studied
Professional Moral Courage of Nursing Students
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Professional Moral Courage of Nursing Students
Timepoint
Immediately before the workshop, immediately at the end of the workshop, 1 month later and 3 months after the intervention, both groups will be examined in terms of the dependent variable.
Method of measurement
Sekarka Professional Moral Courage Questionnaire (2009)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the test group, 1 session of the workshop on ethics concepts will be held. This group will receive the training program of ethics concepts in the form of 1 4-hour workshop. The training program for this group includes teaching concepts such as the 4 principles of medical ethics, including benefit, non-harm, justice, autonomy (informed consent), and concepts such as confidentiality, truthfulness, and disclosure. According to the ethical concepts presented in this workshop, several cases or scenarios will be presented with an ethical approach, and students will examine and criticize the dimensions of the scenarios. Also, until the end of the intervention, moral education materials will be provided in the form of different scenarios and educational videos on the platform of the Telegram group for the students of the test group to complete and consolidate the ethics education.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Nursing, Tehran University of Medical Sciences
Full name of responsible person
Alireza Nikbakht Nasrabadi
Street address
Nursing and Midwifery Faculty, Tehran University of Medical Sciences, Towhid Street
City
Tehran
Province
Tehran
Postal code
1417994575
Phone
+98 930 073 8967
Email
aliakbari.1379110@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
Central Headquarters of Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417994575
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Nikbakht Nasrabadi
Position
Full professor and faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Tehran University of Medical Sciences, Towhid Street
City
Tehran
Province
Tehran
Postal code
1417994575
Phone
+98 930 073 8967
Email
nikbakht@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Nikbakht Nasrabadi
Position
Full professor and faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Tehran University of Medical Sciences, Towhid Street
City
Tehran
Province
Tehran
Postal code
1417994575
Phone
+98 930 073 8967
Email
nikbakht@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari
Position
MSc student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Dormitory, Sa'adat Alley, 16 Azar Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417994575
Phone
+98 930 073 8967
Email
aliakbari.1379110@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only a part of the data, such as the information related to the main outcome or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions and people working in industry
Under which criteria data/document could be used
Expansion of nursing concepts
From where data/document is obtainable
Please contact the corresponding author: [Alireza Nikbakht Nasrabadi] Email: [nikbakht@tums.ac.ir]
What processes are involved for a request to access data/document
Through the first author's email, which usually may take 1 month
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