Protocol summary

Summary
The aim of this study is to determine the effectiveness of teaching based on the theory of planned behavior in mothers about prevention of self-medication in her children. The sample is mothers who attending health centers Azadshahr city with cluster random sampling method. A sample 126 people is divided in to two groups. After the pre-test in both groups, Implement training program is done for the intervention group. At the end of study the post-test will be held in both groups and the results will be analyzed. Inclusion Criteria:women with children under 6 year's old, literate mothers. Exclusion Criteria:lack of desire to continue to participate in the test sample, absence from meeting.The primary outcome: Adopt behaviors to prevent of self-medication in children;The Secondary outcome: Knowledge؛ Attitude؛ Subjective norms؛ Perceived behavioral control and behavioral intention.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2014082118893N1
Registration date: 2014-09-28, 1393/07/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-28, 1393/07/06
Registrant information
Name
Samaneh Mozafari
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3368 4615
Email address
mozafari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Theory-based Education on Promoting Mothers Preventive Behaviors about Self-medication in Children
Public title
The effect of education on the prevention of self-medication.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:women with children under 6 year's old, literate mothers Exclusion Criteria:lack of desire to continue to participate in the test sample, absence from meeting.
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: 126
Randomization (investigator's opinion)
Randomized
Randomization description
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
Golestan University of Medical Sciences
Street address
Golestan, Gorgan, Herkan Boulevard, Golestan University of Medical Sciences
City
Gorgan
Postal code
4934174515
Approval date
2014-07-27, 1393/05/05
Ethics committee reference number
100116393050519

Health conditions studied

1

Description of health condition studied
Education of women with children under 6 year's old in order to prevent self-medication in children
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Adopt behaviors to prevent of self-medication in children.
Timepoint
Before and after the intervention.
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Knowledge؛ Attitude؛ Subjective norms؛ Perceived behavioral control and behavioral intention
Timepoint
Before and after the intervention.
Method of measurement
Questionnaire

Intervention groups

1

Description
Educational intervention such as the use of educational booklet, lecture, questioning and answer, group and individual counseling with mothers.
Category
Prevention

2

Description
The control group received no intervention.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Azadshahr1 Health Center
Full name of responsible person
Samaneh Mozafari
Street address
Azadshahr, Gonbad Street, Azadshahr1 Health Center
City
Azadshahr

2

Recruitment center
Name of recruitment center
Azadshahr2 Health Center
Full name of responsible person
Samaneh Mozafari
Street address
Azadshahr, Gorgan Street, Azadshahr2 Health Center
City
Azadshahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafie
Street address
Arak - Sardashat - Basij Sq - Pardis Educational Complex
City
Arak
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Samaneh Mozafari
Position
MSC
Other areas of specialty/work
Street address
Mustafa Khomeini, Golestan Koi, Department of Public Health
City
Arak
Postal code
3818146851
Phone
+98 86 3368 6443
Fax
Email
mozafari@arakmu.ac.ir ؛ m.mozafari72@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohsen Shamsi
Position
PHD
Other areas of specialty/work
Street address
Mustafa Khomeini, Golestan Koi, Department of Public Health
City
Arak
Postal code
3818146851
Phone
+98 86 3368 6443
Fax
Email
dr.shamsi@arakmu.ac.ir ؛ mohsen_shamsi1360@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Samaneh Mozafari
Position
MSC
Other areas of specialty/work
Street address
Sardasht, Basij SQ, Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 3368 6443
Fax
Email
mozafari@arakmu.ac.ir ؛ m.mozafari72@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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