The effect of educational intervention based on precede model on the performance of mothers with infants in preventive behaviors of middle ear infection
The effect of educational intervention based on precede model on the performance of mothers with infants in preventive behaviors of middle ear infection
Design
Training case including intervention and control groups. One-blind, SPSS software was used on 88 mothers with infants for randomization.
Settings and conduct
This study is performed in Arak health centers on mothers with infants who are registered in the apple system. The study is done in two stages: cross-sectional and intervention. The type of intervention will be educational.
Participants/Inclusion and exclusion criteria
Entry requirements:Mother have infant without otitis media and she and her housband be satisfied to be in the educational intervention and mother have at least 5 calss literacy and mothers home be in arak city,No entry conditions:Reluctance to participate in the study, change of residence of the mother and lack of access to her
Intervention groups
Intervention group: Receiving an educational intervention in the field of strategies to prevent middle ear infection in infants, which is done once a week during 4 training sessions. An educational package containing educational videos, photos, booklets and pamphlets is also given to the intervention group members.
Control group: The members of the control group receive only the routine trainings of the health center. In addition, they receive the training package including booklets and pamphlets and educational videos and photos.
Main outcome variables
Awareness
Attitude
Enabling factot
Reinforcement factors
Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210202050228N1
Registration date:2021-05-21, 1400/02/31
Registration timing:prospective
Last update:2021-05-21, 1400/02/31
Update count:0
Registration date
2021-05-21, 1400/02/31
Registrant information
Name
Atefe Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3862 4348
Email address
a.moradi98@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on precede model on the performance of mothers with infants in preventive behaviors of middle ear infection
Public title
The effect of educational intervention based on precede model on the performance of mothers with infants in preventive behaviors of middle ear infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Mother have infant
Resident of Arak city
Literate (5 literacy classes)
She and her housband's consent to participate in the study
Her child does not currently have a middle ear infection (based on the mother's self-declaration)
Exclusion criteria:
Reluctance to participate in the study
Change of mother's residence
Lack of access to the mother
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization unit is a class. The tool used is SPSS. For this purpose, after entering the list of eligible people to participate in the study in SPSS software, use the random select option to randomly assign samples to the case and control groups. The randomization method is also simple.
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 Arak University of Medical Sciences
Street address
Laleh Blvd., No. 209, Arghavan St
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.ARAKMU.REC.1399.298
Health conditions studied
1
Description of health condition studied
The effect of educational intervention based on precede model on the performance of mothers with infants in preventive behaviors of middle ear infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Knowledge
Timepoint
At the beginning of the study and before the educational intervention. Then 3 months after the end of the educational intervention
Method of measurement
Through a researcher-made questionnaire
2
Description
Attitude
Timepoint
At the beginning of the study and before the educational intervention. Then 3 months after the end of the educational intervention
Method of measurement
Through a researcher-made questionnaire
3
Description
Behavior
Timepoint
At the beginning of the study and before the educational intervention. Then 3 months after the end of the educational intervention
Method of measurement
Through a researcher-made questionnaire
4
Description
Enabling factor
Timepoint
At the beginning of the study and before the educational intervention. Then 3 months after the end of the educational intervention
Method of measurement
Through a researcher-made questionnaire
5
Description
Reinforcement factors
Timepoint
At the beginning of the study and before the educational intervention. Then 3 months after the end of the educational intervention
Method of measurement
Through a researcher-made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving an educational intervention in the field of strategies to prevent middle ear infection in infants, which is done once a week during 4 training sessions. An educational package containing educational videos, photos, booklets and pamphlets is also given to the intervention group members.
Category
Behavior
2
Description
Control group: The members of the control group receive only the routine trainings of the health center. In addition, they receive the training package including booklets and pamphlets and educational videos and photos.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers of Arak city
Full name of responsible person
Atefe Moradi
Street address
Mostafa Khomeini St., Golestan St., Building No. 2 of Arak Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3366 2024
Email
a.moradi98@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Rahele Soltani
Street address
Mostafa Khomeini St., Golestan St., Building No. 2 of Arak Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3366 2024
Email
a.moradi98@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Atefe Moradi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Mostafa Khomeini St., Golestan St., Building No. 2 of Arak Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3366 2024
Email
a.moradi98@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Atefe Mordai
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Mostafa Khomeini St., Golestan St., Building No. 2 of Arak Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3366 2024
Email
a.moradi98@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Atefe Moradi
Position
Univercity student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Mostafa Khomeini St., Golestan St., Building No. 2 of Arak Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3366 2024
Email
a.mo4ad98@arakmu.ac.ir
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
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
After identifying people
When the data will become available and for how long
1 month
To whom data/document is available
researchers
Under which criteria data/document could be used
For information on future research
From where data/document is obtainable
Arak univercity of medical sciences
What processes are involved for a request to access data/document