Protocol summary

Study aim
Determining of the Effect of Education Based on 7E Learning Cycle Model on Knowledge of Diabetic Foot Ulcer Prevention,Critical Thinking and Self-Efficacy of Nursing Students
Design
A clinical trial with a control group, parallel-group, single-blind, randomized، with 100 participants, A coin toss was used for randomization.
Settings and conduct
Students from one of the two classes of the fourth semester of the Bachelor of Nursing course will be randomly selected as the intervention group. Up to 8 people will be divided, and for better education, they will appear at the bedside of patients with diabetes at risk or diabetic foot ulcers. The hospitals covered by Shahid Beheshti University of Medical Sciences.The first session of training will be held in the faculty and the second session will be held in the mentioned hospitals covered by Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:studying in the fourth semester of the Bachelor of Nursing course of the Faculty of Nursing and Midwifery,Shahid Beheshti University of Medical Sciences/passing adult and elderly nursing course3(endocrine and diabetes)at the same time or in the last semester/Passing internship(clinical) units at the time of the study;Exclusion criteria:Unwillingness to participate in research/Attending or enrolling in advanced wound classes outside of the faculty schedule, prior to study.
Intervention groups
Intervention group:They will attend two 45 to 60minute sessions of diabetic foot ulcer prevention training based on the 7E learning cycle model. The control group will receive the common education of adult and elderly nursing course 3 (endocrine and diabetes) at the same time or in the last semester and will attend the relevant internships in the hospital.
Main outcome variables
Diabetic foot ulcer prevention knowledge; Critical thinking ; Self-Efficacy

General information

Reason for update
Acronym
7E
IRCT registration information
IRCT registration number: IRCT20221031056354N1
Registration date: 2022-11-19, 1401/08/28
Registration timing: prospective

Last update: 2022-11-19, 1401/08/28
Update count: 0
Registration date
2022-11-19, 1401/08/28
Registrant information
Name
Mehrad Nekouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7748 1347
Email address
mehrad.nekouei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Education Based on 7E Learning Cycle Model on Knowledge of Diabetic Foot Ulcer Prevention, Critical Thinking and Self-Efficacy of Nursing Students
Public title
Evaluation of the Effect of Education Based on 7E Learning Cycle Model on Knowledge of Diabetic Foot Ulcer Prevention, Critical Thinking and Self-Efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Studying in the fourth semester of the Bachelor of Nursing course of the Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences Passing adult and elderly nursing course 3 (endocrine and diabetes) at the same time or in the last semester Passing internship (clinical) units at the time of the study
Exclusion criteria:
Unwillingness to participate in research Attending or enrolling in advanced wound classes outside of the faculty schedule, prior to study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of students to two test and control groups will be done by a simple random method using the coin toss method and therefore, by chance, one of the two classes will be the test group and the other group will be the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Students of one of the two classes of the fourth semester of the Bachelor of Nursing course of the Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences will be randomly selected as the intervention group. Class A students have classes in the college on the first three days of the week and internships on the second three days of the week, but the program of class B students is the opposite, in that they have internships on the first three days of the week and classes on the second three days of the week. For this reason, the samples are not matched and all the participants think that they will receive the intervention, although the control group will receive the general education of adult and geriatric nursing course 3 (endocrine and diabetes) at the same time or in the last semester. and will not receive training on the prevention of diabetic foot ulcers based on the 7E learning cycle model.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University
Street address
SBMU School of Nursing & Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.163

Health conditions studied

1

Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
L97
ICD-10 code description
Non-pressure chronic ulcer of lower limb, not elsewhere classified

Primary outcomes

1

Description
Knowledge level score of diabetic foot ulcer prevention in Kaya questionnaire
Timepoint
At the beginning of the study (before the intervention) and one month after the educational intervention
Method of measurement
Diabetic foot ulcer prevention knowledge Kaya questionnaire

2

Description
Critical thinking score in Ricketts questionnaire
Timepoint
At the beginning of the study (before the intervention) and one month after the educational intervention
Method of measurement
Ricketts Critical thinking questionnaire

3

Description
Score of General Standard self-efficacy in Schwartzer & Jerusalem questionnaire
Timepoint
At the beginning of the study (before the intervention) and one month after the educational intervention
Method of measurement
Schwartzer & Jerusalem General Standard Self-Efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The participants of the intervention group will attend two 45-60 minute sessions of diabetic foot ulcer prevention training based on the 7E learning cycle model (Elicit, Engagement, Exploration, Explanation, Elaboration, Evaluation and Extending). The first session of training for students of the intervention group in the Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences and the second session in the hospitals covered by Shahid Beheshti University of Medical Sciences (Imam Hossein Hospital, Loghman-e Hakim Hospital, Shohadaye Tajrish Hospital, Shahid Labbafinezhad Hospital , Modarres Hospital) will be held. The students of the intervention group will be divided into groups of 6 to 8 people and for better education, they will attend at the patients’ be with diabetes at risk or with diabetic foot ulcers.
Category
Prevention

2

Description
Control group:The participants of the control group will receive the common education of adult and elderly nursing course 3 (endocrine and diabetes) at the same time or in the last semester and will attend the relevant internships in the hospital.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Roghaye Esmaieli
Street address
SBMU School of Nursing & Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr.Soheila Sadeghi
Street address
Imam Hossein Square, Madani Ave, Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8001
Email
info@ehmc.ir

3

Recruitment center
Name of recruitment center
Loghman-e Hakim Hospital
Full name of responsible person
Dr.Mohamadreza Hajiesmaeili
Street address
Makhsoos St, South Karegar Ave, Loghman-e Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir

4

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Dr.Seyed Pouzhia Shojaei
Street address
Tjirish Square, Shahrdari St., Shohadaye Tjirish Hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir

5

Recruitment center
Name of recruitment center
Shahid Labbafinezhad Hospital
Full name of responsible person
Dr.Sahba Fekri
Street address
Pasdaran St., 9th Bostan, corner of Paydarfard St., Shahid Labafinejad Hospital
City
Tehran
Province
Tehran
Postal code
١٦٦٦٦٦٣١١١
Phone
+98 21 23601
Email
labafinejad.hos@tamin.ir

6

Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Dr.Vahid Eslami
Street address
Saadat Abad St. Yadegare Imam Highway. Modarres Hospital
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
pr_modaress@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
SBMU School of Nursing & Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrad Nekouei
Position
Master of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 5, No. 20, Bayat Alley, Saeed Arab St., Khaghani Crossroad, Damavand St, NewTehran .
City
Tehran
Province
Tehran
Postal code
1745853576
Phone
+98 21 7748 1347
Email
mehrad.nekouei@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Fereshteh Javaheri Tehrani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
fereshte.javaheri@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrad Nekouei
Position
Master of Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 5, No. 20, Bayat Alley, Saeed Arab St., Khaghani Crossroad, Damavand St, NewTehran .
City
Tehran
Province
Tehran
Postal code
1745853576
Phone
+98 21 7748 1347
Email
mehrad.nekouei@sbmu.ac.ir

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
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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