Investigating the Effect of Teaching Ethical Principles Using the Flipped Classroom Method on Distress and Moral Sensitivity in Neonatal Intensive Care Unit Nurses
Assessing the impact of flipped classroom ethical principles training on ethical distress and ethical sensitivity among nurses in neonatal and pediatric intensive care units.
Design
This two-group clinical trial includes 80 participants selected by total enumeration and randomly assigned to intervention and control groups. Blinding of researchers and participants is not feasible, but the statistician remains unaware of group allocation.
Settings and conduct
Eighty nurses from Children’s Medical Center in Tehran were selected via total enumeration and randomly assigned to intervention and control groups. The control group receives standard hospital training, while the intervention group also receives flipped-classroom nursing ethics education
Participants/Inclusion and exclusion criteria
Nurses with at least a bachelor's degree in nursing and a minimum of six months of experience in neonatal and pediatric intensive care units. (due to having the minimum required training)
Intervention groups
After validation by nursing ethics experts, intervention group members were contacted to complete "ethical sensitivity" and "ethical distress" questionnaires. They received electronic educational content on ethical distress, resilience, and ethics knowledge, which they studied before attending three two-hour in-person sessions involving review, exercises, and discussions. Participants were continuously evaluated and given feedback. The control group received only standard hospital training.
Main outcome variables
moral distress; moral sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220203053920N4
Registration date:2025-05-29, 1404/03/08
Registration timing:prospective
Last update:2025-05-29, 1404/03/08
Update count:0
Registration date
2025-05-29, 1404/03/08
Registrant information
Name
Reihane Moghimian Shahrbabaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9438
Email address
moghimianreihane1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Teaching Ethical Principles Using the Flipped Classroom Method on Distress and Moral Sensitivity in Neonatal Intensive Care Unit Nurses
Public title
Investigating the Effect of Teaching Ethical Principles Using the Flipped Classroom Method on Distress and Moral Sensitivity in Neonatal Intensive Care Unit Nurses in Tehran Infant Medical Center
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses who hold at least a Bachelor's degree in Nursing.
Nurses who have worked in the Neonatal and Pediatric Intensive Care Unit for at least six months. (So that they have received at least basic initial training.)
Exclusion criteria:
failure to meet the eligibility criteria for participation in the study
failure to attend two sessions of the training courses
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random Sampling and Randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical committee of Kerman University of Medical Sciences
Street address
No. 2, floor, on the right., Alley 21 North 1., Bastani Paryizi Blvd., Kerman Town
City
Kerman
Province
Kerman
Postal code
7615864899
Approval date
2024-12-10, 1403/09/20
Ethics committee reference number
IR.KMU.REC.1403.471
Health conditions studied
1
Description of health condition studied
distress and moral sensitivity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Moral distress, moral sensitivity
Timepoint
Before the start of the intervention (holding the training sessions) and after completing the education via flipped classroom methods, with a total duration equivalent to four weeks.
Method of measurement
The Corley Ethical Stress Questionnaire, The Lutzen Ethical Sensitivity Questionnaire, Demographic Information Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nurses working in Neonatal and Pediatric Intensive Care Units.
Category
Behavior
2
Description
Control group: Nurses working in Neonatal and Pediatric Intensive Care Units.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center Hospital, Tehran City.
Full name of responsible person
Roghaye Badakhshan
Street address
No. 62, Dr. Mohammad Gharib Street, End of Keshavarz Boulevard, Next to Imam Khomeini Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9999
Fax
+98 21 6693 0024
Email
cmcpr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Sharifi PHD
Street address
Kerman University of Medical Sciences, Medical univesity Beginning of Haft Bagh-e-Alavi , Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
CRA@kmu.ac.ir
Web page address
https://www.kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Monirsadat Nematollahi
Position
Associate Professor and Head of the Pediatric Nursing and Neonatal Care Department
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5196
Fax
+98 34 3132 5218
Email
m.nematolahi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Monirsadat Nematollahi PHD
Position
Associate Professor and Head of the Pediatric Nursing and Neonatal Care Department.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5196
Fax
+98 34 3132 5218
Email
m.nematolahi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nematollahi Monirsadat
Position
Master’s student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, Block 401, Bu Ali Residential Complex, Kooey Faraz, Saadat Abad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981978113
Phone
+98 21 2214 0275
Email
roghaye.badakhshan1363@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available