Determining the effect of intervention based on the health belief model on preventive behaviors of hydatidosis in rural communities
Design
This study is a clinical trial with an intervention group and a control group, with parallel groups, and random allocation through a coin toss method; and a census of all people in the village, which will be performed without blinding on 68 patients.
Settings and conduct
This study will be conducted in Jovein City in 2 rural areas of Abbasabad Malek and Ahmedabad Malek on 68 research samples that will be placed in two intervention and control groups. This clinical trial will be conducted by randomly assigning one of the villages to the intervention group and the other to the control group.
Participants/Inclusion and exclusion criteria
Inclusion critria:
Willingness to participate in the study
Literate to read and write
Having a personal cell phone
being in age group of 18 to 65 years
Exclusion criteria:
Reluctance to participate in the study
Migration from the village during the study
Absence in more than one training session
Intervention groups
intervention group:
One of the villages will be randomly placed in the intervention group, which will receive 2 training sessions based on the health belief model of hydatidosis prevention in addition to the routine care of the health center.
control group:
Another village will be randomly assigned to the control group, which will receive the routine care of the health center.
Main outcome variables
Prevention of hydatid disease in rural communities
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240625062254N1
Registration date:2024-07-07, 1403/04/17
Registration timing:prospective
Last update:2024-07-07, 1403/04/17
Update count:0
Registration date
2024-07-07, 1403/04/17
Registrant information
Name
sedigheh mehrandish
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4549 3326
Email address
smehrandish6@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intervention based on the health belief model on preventive behaviors of hydatidosis in rural communities
Public title
effect of the health belief model on prevention of hydatidosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being able to write and read
being between 18-65 years old
having his/her own self-phone
Exclusion criteria:
History of participation in training courses
Immigrants
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
This randomized clinical trial will be conducted in 2 rural areas of Abbas Abad Malek and Ahmad Abad Malek in Jovein City, on 68 samples who will be allocated randomly into two intervention and control groups. The random allocation process will be decided by a coin toss, in which one of the villages will be determined as the intervention group and the other as the control group.
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 Mashhad University of Medical Sciences
Street address
University St., Razavi Khorasan, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Approval date
2024-06-22, 1403/04/02
Ethics committee reference number
IR.MUMS.REC.1403.098
Health conditions studied
1
Description of health condition studied
hydatidosis
ICD-10 code
B67
ICD-10 code description
Echinococcosis
Primary outcomes
1
Description
The score obtained from the KAP questionnaire
Timepoint
before and after the intervention
Method of measurement
KAP questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:For the intervention group, a training session will be held in the village mosque or health house based on the structures of the health belief model in 2 training sessions of 45-60 minutes during two weeks
Category
Prevention
2
Description
Control group: No meeting will be held for the control group. Only the routine training of the health center is received
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Neqab Health Center
Full name of responsible person
Mohammadreza Sadr
Street address
Iran, Khorsan Razavi, Neghab city
City
Jovein
Province
Razavi Khorasan
Postal code
9647195433
Phone
+98 51 4522 2266
Email
hasanih2@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Hajiabadi
Street address
University St., Mashhad, Razavi Khorasan, Iran
City
Mashahd
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3841 2081
Email
p.relations@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Mehrandish
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neghab, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9647195433
Phone
+98 51 4401 6157
Email
smehrandish6@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Hajiabadi
Position
Assistant Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahd, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
009838412081
Email
HajiabadiF@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Mehrandish
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9647195433
Phone
0098514401657
Email
smehrandish6@gmail.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
Yes - There is 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
Not applicable
Title and more details about the data/document
The dataset will be published in related journals.
When the data will become available and for how long
the dataset will be published alongside the original article.
To whom data/document is available
the dataset will be publicly published.
Under which criteria data/document could be used
the data will be accessible for future analyses and assessments.
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document