General purpose: determination the effect of self care education By workshop method for mothers in prevention of self medication to children
Design
Clinical trials with community based control group, with parallel and randomized blocks, with a block size of 53 samples per group (106)
Settings and conduct
The present study is a randomized clinical trial study. The research population includes all mothers under the age of six years covered by health centers in Shazand. Methods: At first, the pretest will be taken from the control group and then the pretest and educational intervention will be performed for the test group. The control group will receive the usual care at the center. The research includes 5 sessions of 2 hours in a workshop that includes education self care in mild illnesses in children and self-medication in this regard and the expression of the complications and consequences of drug abuse for children based on cognitive theory constructs The Bandura Social will be taught .
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Mothers with child under the age of 6 years
Mothers who have the ability to read and write
Mothers self reported about not having mental problems
Mothers with child without chronic disease
Exclusion criteria:
Mothers who are Health Ambassadors
Unwillingness to continue to participate in research
Absence of more than two consecutive sessions in classrooms
Intervention groups
Intervention group: Participate in training sessions includes 5 sessions 2 hours with self-care educational content in minor children's illnesses
Control group: Get regular care at the health center
Main outcome variables
Self-care education based on the structures of social cognitive theory
Self-care knowledge, Expectations of the consequences , Social support, Self efficacy in self care
Mothers' practice in self medication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180524039819N1
Registration date:2018-07-28, 1397/05/06
Registration timing:prospective
Last update:2018-07-28, 1397/05/06
Update count:0
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
Akram Naeimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
a-naeimi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-30, 1397/05/08
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self care education By workshop method for mothers in prevention of self medication to children
Public title
The effect education in prevention of self medication
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with child under 6 years of age
Mothers who have the ability to read and write
Mothers self-reported about not having mental problems
Mothers with child without chronic disease
Exclusion criteria:
Mothers who are Health Ambassadors
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block
Random unit: Individual
Randomization Tool: Online Software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Use of Bandura Social Cognitive Theory
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghodss St,Keshavarz Blvd, Central Office of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-09-05, 1396/06/14
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3391
Health conditions studied
1
Description of health condition studied
Prevention of self medication
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Practice on self medication
Timepoint
Before the beginning of the study and 3 months after the educational intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Knowledge and awareness
Timepoint
Before the beginning of the study and 3 months after the educational intervention
Method of measurement
Questionnaire
2
Description
Expect the outcome
Timepoint
Before the beginning of the study and 3 months after the educational intervention
Method of measurement
Questionnaire
3
Description
Social support
Timepoint
Before the beginning of the study and 3 months after the educational intervention
Method of measurement
Questionnaire
4
Description
Self-efficacy
Timepoint
Before the beginning of the study and 3 months after the educational intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: 5 sessions of 2 hours, in a workshop for 2 months, the content of the education included self-care book on minor illnesses the part childhood approved by the Ministry of Health and Medical Education
Category
Prevention
2
Description
Control group: Get regular health care center care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Services Centers number1
Full name of responsible person
Majid Shams
Street address
Enghelab Street, Imam Hossein Square,Comprehensive Health Services Center
City
Shazand
Province
Markazi
Postal code
3861818547
Phone
+98 86 3822 2050
Fax
+98 86 3822 6377
Email
shazandshabakeh@arakmu.ac.ir
Web page address
https://shazanddh.arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Ghods St,Keshavarz Blvd, Central Organization of the University, Sixth Department of Research and Technology
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Akram Naeimi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr Mirkhani St. (Eastern Nusrat), Tavid Square, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
mnaeimi88@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahzad PashaeiPour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr Mirkhani St. (Eastern Nusrat),Tavid Square. School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
pashaeypoor.sh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akram Naeimi
Position
Student Master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr Mirkhani St. (Eastern Nusrat),Tavid Square,Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
mnaeimi88@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main implications are interchangeable, including mothers'practice in self medication use and And the effect of education on the structures of social cognitive theory
When the data will become available and for how long
Start one year after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to data and documentation is available in accordance with Tehran University of Medical Sciences
From where data/document is obtainable
To access the data, I am referring to Akram Naeimi
E-mail: mnaeimi88@yahoo.com
What processes are involved for a request to access data/document
The applicant receives the data after sending the email to the address given and presenting the goals of accessing the data and after clarifying the accuracy of the goals according to the criteria of the Tehran University of Medical Sciences and the magazine that scanned the article can access the data.