Protocol summary

Summary
This experimental study will be conducted on 100 mothers of children aged 3 to 6 years old under the coverage of Healthcare Center No 1 in the city of Ilam in two groups, intervention and control. The educational intervention will be based on Health Belief Model components in the intervention group in which perceived severity, susceptibility, benefits, and barriers, self-efficacy, and cues to action as well as oral health behaviors of mothers to children and dental plaque index are measured. The study population is composed of mothers of children aged 3 to 6 years old referred to Healthcare Center No 1 in the city of Ilam. After providing a full description of the study procedure, mothers will complete a consent form. The inclusion criteria are mothers with children aged 3 to 6 years old, coverage by Health Center No 1, and mothers’ willingness to participate in the study. The exclusion criteria are absence of women in all educational classes, lack of children’s cooperation in oral examinations, and dental plaque measurement. To perform this study, Health Center No 1 in the city of Ilam is selected because of its activity and the large population of children aged 3 to 6 years old. After obtaining written permission from Ilam University of Medical Sciences, it is presented to Health Center No 1 to follow the legal procedure of entry into the research context. The first step of the study (before intervention) includes children’s oral examination and completion of the questionnaire; afterwards, the educational intervention will be conducted in three 45-minute sessions; and the second step of the study (after intervention) includes children’s oral re-examinations and completion of the questionnaire. Finally, the data will be analyzed by using the SPSS software version 16.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014112220031N1
Registration date: 2016-02-18, 1394/11/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-18, 1394/11/29
Registrant information
Name
Maryam Esmaili Kia
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3335 4724
Email address
esmaili66leila@gmail.com
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Sciences
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education to mothers based on health Belif model on decreasing dental plaque index of 3-6 years old children of Ilam city in 2015.
Public title
The effect of education on decreasing dental plaque index
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria are mothers with children aged 3 to 6 years old, coverage by Health Center No 1, and mothers’ willingness to participate in the study. The exclusion criteria are absence of women in all educational classes, lack of children’s cooperation in oral examinations, and dental plaque measurement.
Age
From 2 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Ilam University of Medical Sciences
Street address
Ilam
City
Banganjab, Pajoohesh Blvd., Ilam City
Postal code
6939177143
Approval date
2015-10-13, 1394/07/21
Ethics committee reference number
IR.Medilam.REC.1394.72

Health conditions studied

1

Description of health condition studied
Plauqe Dental
ICD-10 code
K05.5
ICD-10 code description
Other Periodonta Diseases

Primary outcomes

1

Description
oral health behavior
Timepoint
pre test intervention, 30 days after last educational program
Method of measurement
Questionari

Secondary outcomes

empty

Intervention groups

1

Description
intervention based on is structures on three sessaion ,intervention class is resercher is hold, that are education oral health, care health, plauqe dental preventive.
Category
Prevention

2

Description
in control group is done normal care.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Healthcare Center No 1 in the city of Ilam
Full name of responsible person
Maryam Esmaili kia
Street address
Shahid Bashiri Alley, Edalat Blvd, Fatehan Memak Squre, Ilam City.
City
Ilam

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Behzad Badakhsh
Street address
Banganjab, Pazhohesh Streat, Ilam City.
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Amin Mirzaei
Position
Ph.d
Other areas of specialty/work
Street address
Banganjab, Pazhohesh Streat, Ilam.
City
Ilam
Postal code
6939177143
Phone
+98 84 3223 5734
Fax
Email
amin.mirzaei@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Zeinab Ghazanfari
Position
Ph.d
Other areas of specialty/work
Street address
Banganjab, Pazhohesh Streat, Ilam.
City
Ilam
Postal code
6939177143
Phone
+98 842235735
Fax
Email
zghazanfari2006@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ilam, University of Medical Science
Full name of responsible person
Leda Hemati
Position
Employee
Other areas of specialty/work
Street address
Banganjab, Pazhohesh Streat, Ilam.
City
Ilam
Postal code
6939177143
Phone
+84 2235734
Fax
Email
Hematile@gmail.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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