Determining the effect of education based on the BASNEF model in control and prevention of cutaneous leishmaniasis in students
Design
This is a two arm parallel groups randomized trial. In Phase 2, 70 students who will be randomly divided to intervention and control groups will be enrolled in the study.
Settings and conduct
The sampling method in this study will be random sampling, so that among the cities of the eastern region of Isfahan, Nasrabad and Mohammadabad, which have a high prevalence of leishmaniasis, and are also similar in terms of demographic variables will be selected as the place of the study.
Among these cities, one will be considered randomly to select the students of the intervention group and the other to select the control group. One high-school in each city and one class from each high-school will randomly be selected. All the students of the selected class will be enrolled in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1: Student of the first high-school in Nasrabad and Mohamadabad
2: Students and parent's consent to participate in the study
Exclusion criteria
1: Absence from more than one educational session
2: incomplete completion of questionnaire
Intervention groups
This intervention will be done based on the BASNEF model's constructs.Three educational sessions is considered for the students and one session for their parents. The written content of sessions will be provided to students of the control group after ending training.
Main outcome variables
Improving BASNEF model structures (knowledge, attitude, abstract norms and enabling factors) in the intervention group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201024049131N1
Registration date:2020-11-20, 1399/08/30
Registration timing:prospective
Last update:2020-11-20, 1399/08/30
Update count:0
Registration date
2020-11-20, 1399/08/30
Registrant information
Name
Hossein Shahnazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3243
Email address
gh.alizadeh1397@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Educational Intervention Based on the BASNEF Model on Preventive Behaviors of Leishmaniasis among ّFirst high school boy Students
Public title
The effect of educational intervention based on the BASNEF model on preventive behaviors of leishmaniasis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ُStudent of the first high school of Nasrabad and Mohammadabad
Students and parent's consent to participate in the study
Exclusion criteria:
Absence from more than one training session
Incomplete completion of the questionnaire
Age
From 12 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method will be used in this study. Group random allocation is considered to sample selection. At first, one of the two cities where the study will be conducted will be considered randomly to select the intervention group and the other to select the control group. A boys' high school is randomly selected from each city, and a class is selected from each high school, and all students in that class will be enrolled in the study.
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 Isfahan University of Medical Sciences
Street address
School of health- Isfahan University of Medical Sciences- Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-07, 1399/08/17
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.463
Health conditions studied
1
Description of health condition studied
CUTANEOUS LEISHMANIASIS
ICD-10 code
L00–L99
ICD-10 code description
Diseases of the skin and subcutaneous tissue
Primary outcomes
1
Description
Knowledge
Timepoint
Before training and 2 months after training
Method of measurement
BASNEF Questionnaire
2
Description
Attitude
Timepoint
Before training and 2 months after training
Method of measurement
BASNEF Questionnaire
3
Description
Subjective norms
Timepoint
Before training and 2 months after training
Method of measurement
BASNEF Questionnaire
4
Description
Enabling factors
Timepoint
Before training and 2 months after training
Method of measurement
BASNEF Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
This intervention will be done based on the BASNEF model's constructs.Three educational sessions is considered for the students using lecture,group discussion and role-playing and one session will be held for their parents with lecture and demonstration.
Category
Prevention
2
Description
Control group: The written form of educational content will be provided to the students of control group after ending training sessions.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Health Center
Full name of responsible person
Hossein Shahnazi
Street address
School of Health, Isfahan University of Medical Sciences, Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Street address
School of Health, Isfahan University of Medical Sciences, Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, Isfahan University of Medical Sciences, Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, Isfahan University of Medical Sciences, Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, Isfahan University of Medical Sciences, Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
009837923243
Email
h_shahnazi@yahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the information about the main outcome
When the data will become available and for how long
One year after the results are published
To whom data/document is available
Researchers working in scientific institutions, local and education authorities
Under which criteria data/document could be used
Having permission from Isfahan University of Medical Sciences
From where data/document is obtainable
Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
The applicant for receiving the documents can submit his/her request through the Vice Chancellor for Research of Isfahan University of Medical Sciences one year after the publication of the results .