Protocol summary

Study aim
Determining the Impact of Kitchener's Ethical Decision-Making Model Training on the Moral Sensitivity and Reasoning of Emergency Nurses
Design
This experimental study, with two groups (intervention and control, each consisting of 44 participants), is designed to assess the impact of teaching ethical concepts based on the Kitchener model (through lectures and scenarios) on the ethical reasoning and sensitivity of emergency department nurses in hospitals in Bandar Abbas. Sampling is done using stratified random sampling, and the samples are randomly allocated to the intervention and control groups.
Settings and conduct
This experimental study consists of two groups: an intervention group and a control group, each comprising 44 participants. Stratified random sampling is utilized, followed by random allocation into the two groups, conducted within the emergency departments of hospitals in Bandar Abbas.The individual who enters the data and performs the analysis will be blinded.
Participants/Inclusion and exclusion criteria
Sampling will be conducted among emergency department nurses in Bandar Abbas hospitals. Inclusion criteria include: not having attended ethics workshops in the past three months, holding at least a bachelor's degree, willingness to participate in the workshop, and no history of mental illness in the past year. Exclusion criteria include absence from more than two workshop sessions and participation in ethics workshops during the intervention period.
Intervention groups
The training sessions will be held at least once a week, using lecture and scenario-based methods, with each session lasting between 45 to 60 minutes. A total of 7 training sessions will be held.
Main outcome variables
moral sensitivity and moral reasoning

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241010063325N1
Registration date: 2024-12-10, 1403/09/20
Registration timing: prospective

Last update: 2024-12-10, 1403/09/20
Update count: 0
Registration date
2024-12-10, 1403/09/20
Registrant information
Name
Fereshteh Salarpour mohammad moradi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 917 397 6545
Email address
f.salarpour@modares.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-05-20, 1404/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effectiveness of Teaching Ethical Concepts Based on Kitchener's Ethical Decision-Making Model on the Moral Sensitivity and Reasoning of Emergency Nurses.
Public title
Investigating the Impact of Ethical Decision-Making Training on the Moral Sensitivity and Reasoning of Nurses.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Non-participation in ethics training workshops 3 months prior to entering the study Holding at least a bachelor's degree Willingness to participate in an ethics workshop Absence of mental health disorders in the past year according to self-report
Exclusion criteria:
do not satisfy to participate in all sessions all nurses who are not in fixed shifts
Age
From 22 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, stratified random sampling will be used. For this purpose, hospitals will be considered as strata for sampling. The proportion of emergency nurses in each hospital to the total number of emergency nurses across all six hospitals will determine the share of each hospital in the sampling. Within each hospital, the sample will be randomly selected. First, numbers will be assigned to the members of each hospital, and then the desired number of participants will be randomly chosen from these numbers. The selected individuals will be randomly allocated to intervention and control groups using random numbers so that each group will consist of 44 participants. Random assignment to the two test and control groups will ensure that each individual has an equal chance of being placed in either group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person entering the data and performing the analysis must remain blinded.
Placebo
Not used
Assignment
Other
Other design features
The specific objectives of the study include the following: Reducing stress Improving nurses' performance To measure stress levels, the Depression Anxiety Stress Scales-21 (DASS-21) will be used. This instrument, hereafter referred to as DASS-21, is widely utilized for the assessment of these psychological variables. Additionally, to evaluate nurses' performance, the Rest’s Moral Judgment Test (1973) will be employed. In this study, this tool will serve to measure the primary variable, namely, nurses' moral reasoning. The instrument not only assesses an individual's ability to engage in moral reasoning but also evaluates nurses' performance in addressing ethical situations and making clinical decisions. In other words, Rest’s Moral Judgment Test provides a robust measure of moral reasoning levels while also enabling the assessment of nurses’ practical responses to ethical issues in clinical practice.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modares University
Street address
Tehran, Jalal Al Ahmad, Paul Nasr, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2024-11-24, 1403/09/04
Ethics committee reference number
IR.MODARES.REC.1403.124

Health conditions studied

1

Description of health condition studied
Moral sensitivity and reasoning
ICD-10 code
F59
ICD-10 code description
Unspecified behavioral syndromes associated with physiological disturbances and physical factors

2

Description of health condition studied
Ethical decision making
ICD-10 code
F53
ICD-10 code description
Puerperal psychosis

Primary outcomes

1

Description
Moral sensitivity
Timepoint
Before starting the study, immediately and two months after the end of the study
Method of measurement
To measure moral sensitivity among nurses, the Moral Sensitivity Questionnaire (MSQ) developed by Lützén et al. will be utilized. This instrument, hereafter referred to as MSQ, is a validated and widely used tool for assessing moral sensitivity in various ethical situations encountered in the nursing profession. The MSQ, designed by Lützén and colleagues, examines different dimensions of moral sensitivity and evaluates nurses’ ability to identify and respond to ethical challenges in clinical settings. In other words, this instrument serves as a comprehensive measure of nurses’ awareness and responses to ethical issues.

2

Description
Moral reasoning
Timepoint
Before starting the study, immediately and two months after the end of the study
Method of measurement
Standard Moral Reasoning Questionnaire (Rost et al. 1973)

Secondary outcomes

1

Description
Reduce stress
Timepoint
Before and after and 2 months after intervention
Method of measurement
To measure the levels of depression, anxiety, and stress, the Depression Anxiety Stress Scales-21 (DASS-21) questionnaire was used. This instrument, hereafter referred to as DASS-21, is widely utilized for the assessment of these three psychological variables.

2

Description
Improving the performance of nurses
Timepoint
before and after and 2 months after intervention
Method of measurement
To measure moral sensitivity among nurses, the Moral Sensitivity Questionnaire (MSQ) developed by Lützén et al. will be utilized. This instrument, hereafter referred to as MSQ, is a validated and widely used tool for assessing moral sensitivity in various ethical situations encountered in the nursing profession. The MSQ, designed by Lützén and colleagues, examines different dimensions of moral sensitivity and evaluates nurses’ ability to identify and respond to ethical challenges in clinical settings. In other words, this instrument serves as a comprehensive measure of nurses’ awareness and responses to ethical issues.

Intervention groups

1

Description
Intervention group:This group consists of 44 emergency nurses who will receive training on ethical concepts based on the steps of Kitchener's model, aimed at enhancing their ethical reasoning and sensitivity. The training sessions will be conducted weekly, utilizing a combination of lectures and scenario-based methods. Each session will last 45–60 minutes and will be repeated within the same week for those unable to attend. Over two months, a total of seven educational sessions are planned. The educational content is specifically designed in alignment with the steps of Kitchener's model.
Category
Behavior

2

Description
Control group: This group comprises 44 nurses working in the emergency department who will not receive any educational intervention during the study. Members of this group will only participate in the pre-test and post-test assessments. To uphold ethical principles in research, the educational content will be provided to the control group after the study's completion, ensuring equal opportunities to learn ethical concepts. Additionally, as an expression of gratitude for their cooperation, each participant will receive a flash drive as a token of appreciation.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Mitra Khoobi
Street address
Farhangian Neighborhood, Bandar Abbas, Hormozgan Province
City
Bandar Abbas
Province
Hormozgan
Postal code
۷۹۱۷۷۱۶۹۸۵
Phone
+98 76 3334 7000
Email
info@hums.ac.ir

2

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Mitra Khoobi
Street address
Dr. Ali Shariati Hospital, Next to the Revolutionary Court, Shaheed Naser Boulevard, Bandar Abbas, Hormozgan Province
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 2424
Email
info@hums.ac.ir

3

Recruitment center
Name of recruitment center
Children's Hospital
Full name of responsible person
Mitra Khoobi
Street address
Golshahr-e Shomali, Imam Khomeini Boulevard, Bandar Abbas, Hormozgan Province
City
Bandar Abbas
Province
Hormozgan
Postal code
7915873665
Phone
+98 76 3366 6240
Email
kdkh@hums.ac.ir

4

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mitra Khoobi
Street address
Northern Side of Astaneh Seyyed Mozaffar, Imam Khomeini Boulevard, Bandar Abbas, Hormozgan Province
City
Bandar Abbas
Province
Hormozgan
Postal code
۷۹۱۵۷۵۳۳۷۵
Phone
+98 76 3333 3338
Email
emamrezahospital@gmail.com

5

Recruitment center
Name of recruitment center
Ome Leila Hospital
Full name of responsible person
Mitra Khoobi
Street address
Umm Leila Hospital, Behind Astaneh Seyyed Mozaffar, Naiband-e Shomali, Imam Khomeini Boulevard, Bandar Abbas, Hormozgan Province
City
Bandar Abbas
Province
Hormozgan
Postal code
7915753615
Phone
+98 76 3333 3339
Email
online@omeleilahospital.ir

6

Recruitment center
Name of recruitment center
Persian Gulf Hospital
Full name of responsible person
Mitra Khoobi
Street address
Pardis Boulevard, Azad University Street, Imam Khomeini Boulevard, Bandar Abbas, Hormozgan Province
City
Bandar Abbas
Province
Hormozgan
Postal code
٧٩١٩٧٨٣١٤١
Phone
+98 76 3367 0286
Email
info@tamin.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University - Research Affairs Deputy
Full name of responsible person
Dr. Mohammad Javan
Street address
Tehran, Jalal Al Ahmad, Paul Nasr, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Email
m.khoobi@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University - Research Affairs Deputy
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
Tarbiat Modares University, School of Medical Sciences
Full name of responsible person
Mitra Khoobi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jalal Al Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3554
Email
m.khoobi@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mitra Khoobi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jalal Al Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3554
Email
m.khoobi@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mitra Khoobi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jalal Al Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
009882883590
Email
m.khoobi@modares.ac.ir

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
statistical data is considered and can be shared after code insertion.
When the data will become available and for how long
Starting to access data from 2025
To whom data/document is available
Access to the data is open to all interested parties
Under which criteria data/document could be used
for generalization on the same group is useful.
From where data/document is obtainable
Dr. Mitra Khoobi
What processes are involved for a request to access data/document
Official application by email
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