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The Effect of Education Based on Leininger's Nursing Model on Nurses' Cultural Competence: A Randomized Controlled Trial.

Protocol summary

Study aim
To determine the effect of training based on Leininger’s nursing model on nurses' cultural competence.
Design
A randomized controlled trial with a control group and a parallel-group design.
Settings and conduct
This study will be conducted at teaching hospitals in Yasuj. The intervention group will receive training based on Leininger's model, while the control group will continue to receive routine care; the study will be conducted without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Employment at teaching hospitals in Yasuj, age 23–60, minimum of a bachelor's degree, at least one year of clinical experience, informed consent, and active employment. Exclusion criteria: Unwillingness to continue participation, withdrawal from the study, or failure to complete the research procedures.
Intervention groups
Intervention Group: Nurses in this group will receive education based on Leininger’s Nursing Model to improve their cultural competence. Their cultural competence will be assessed before and after the intervention. Control Group: Nurses in this group will not receive education based on Leininger’s Nursing Model and will continue their usual activities. Their cultural competence will be assessed at the same time points as the intervention group.
Main outcome variables
Nurses’ cultural competence, measured before the intervention, immediately after the intervention, and two months after the intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20261013071423N1
Registration date: 2026-10-14, 1405/07/22
Registration timing: prospective

Last update: 2026-10-14, 1405/07/22
Update count: 0
Registration date
2026-10-14, 1405/07/22
Registrant information
Name
Hassan Jahanbin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 0327
Email address
hassanjahanbin0@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-10-16, 1405/07/24
Expected recruitment end date
2026-10-31, 1405/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Education Based on Leininger's Nursing Model on Nurses' Cultural Competence: A Randomized Controlled Trial.
Public title
Effect of Education Based on Leininger’s Nursing Model on Nurses’ Ability to Provide Culturally Appropriate Care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses working in teaching hospitals affiliated with Yasuj University of Medical Sciences. Nurses aged between 23 and 60 years Holding at least a bachelor's degree Having at least one year of clinical work experience. Willingness to participate in the study and provision of informed consent Being employed under a permanent, temporary (contractual), or active compulsory service (طرحی) employment arrangement at the time of the study.
Exclusion criteria:
History of substance and alcohol abuse Experience participating in training courses similar to cultural competence.
Age
From 23 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 156
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be used to assign the study hospitals to the research groups. Among the eligible teaching hospitals affiliated with Yasuj University of Medical Sciences, two hospitals will be assigned to the intervention group and one hospital to the control group. Subsequently, the required number of eligible nurses working in the clinical wards of the selected hospitals will be recruited using stratified sampling with proportional allocation. Clinical wards will be considered sampling strata, and the sample size for each ward will be determined proportionally to the number of eligible nurses working in that ward. Finally, eligible nurses will be randomly selected from the list of nurses in each ward.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
Enghelab Boulevard, Enghelab 20, Shahid Fattah Abbasi Street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75913693556
Approval date
2026-10-13, 1405/07/21
Ethics committee reference number
IR.YUMS.REC.1405.145

Health conditions studied

1

Description of health condition studied
Nurses' Cultural Competence
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The total score of nurses’ cultural competence measured using the 51-item Moulder Cultural Competence Questionnaire, with a score range of 51 to 255. A higher score indicates greater cultural competence.
Timepoint
Before the intervention, immediately after the intervention, and two months after the intervention.
Method of measurement
The Persian version of the Moulder Cultural Competence Questionnaire consists of 51 items across four subscales: cultural care knowledge, attitudes toward cultural care, cultural competence, and cultural care readiness. The questionnaire uses a five-point Likert scale, with a total score ranging from 51 to 255. The Persian version was psychometrically evaluated by Bastami et al. in 2016, with a reported Cronbach’s alpha coefficient of 0.86.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Nurses in this group will receive education based on Leininger’s Nursing Model to improve their cultural competence. Cultural competence will be assessed using the Moulder Cultural Competence Questionnaire before the intervention, immediately after the intervention, and two months later.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid beheshti hospital, Shahid jalil hospital, Imam sajad hospital
Full name of responsible person
Hassan Jahanbin
Street address
Enghelab Boulevard, Enghelab 20, Shahid Fattah Abbasi Street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591369356
Phone
+98 917 572 5761
Email
hassanjahanbin0@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hassan Jahanbin
Street address
Enghelab Boulevard, Enghelab 20, Shahid Fattah Abbasi Street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591369356
Phone
+98 917 572 5761
Email
hassanjahanbin0@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Hassan Jahanbin
Position
Master's student in management nursing, Student Research Committee, Yasuj University Of Medical Scie
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Master's student in management nursing, Student Research Committee, Yasuj University Of Medical Science, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591369356
Phone
+98 74 3323 0327
Email
hassanjahanbin0@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hassan Jahanbin
Position
Master's student in management nursing, Student Research Committee, Yasuj University Of Medical Scie
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Enghelab Boulevard, Enghelab 20, Shahid Fattah Abbasi Street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591369356
Phone
+98 74 3323 0327
Email
hassanjahanbin0@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hassan Jahanbin
Position
Master's student in management nursing, Student Research Committee, Yasuj University Of Medical Scie
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Enghelab Boulevard, Enghelab 20, Shahid Fattah Abbasi Street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591369356
Phone
+98 74 3323 0327
Email
hassanjahanbin0@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the need to maintain participant confidentiality and the limited scope of this academic study, there is currently no plan to share individual participant data. The study results will be reported in aggregate form without disclosing participants’ identities.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Study Protocol and Final Study Report: These documents will include the study objectives, methodology, implementation of the educational intervention based on Leininger’s Nursing Model, the instrument used to assess nurses’ cultural competence, and the overall study results. No identifiable or confidential participant information will be disclosed.
When the data will become available and for how long
The study protocol will be made available after finalization, subject to publication feasibility. The final study report will be made available after study completion and publication of the results, subject to applicable conditions.
To whom data/document is available
Researchers, academic faculty members, and university students may request access to the published study documents. Access is subject to compliance with research ethics principles and the confidentiality of participant information.
Under which criteria data/document could be used
The documents may be used for scientific, educational, and research purposes. Users must comply with research ethics principles, provide appropriate citations, and maintain confidentiality. Commercial use and any attempt to identify study participants are not permitted.
From where data/document is obtainable
Requests for access to the study documents may be directed to the principal investigator at Yasuj University of Medical Sciences. Contact details and the method of access will be provided once the official dissemination route has been determined.
What processes are involved for a request to access data/document
Requests should be submitted in writing and should include a description of the intended purpose of using the documents. The principal investigator will review each request to ensure compliance with research ethics principles. If approved, the available documents will be provided through an agreed method. The response time will depend on the nature of the request and the availability of the documents.
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