Protocol summary

Summary
Statistics prove the necessity of planning for the prevention of tooth decay in all populations, especially pregnant mothers. In order to achieve this goal, the researchers used the model to changes in behavior that one of these models is affecting the health of the health belief model. Study design and implementation of a systematic training program tries to find ways of improving the health of mothers and children to take a step in this study is a randomized controlled trial and a blind.110 sample of pregnant women attending 15 health centers in Rasht (33 bases) were selected using systematic random sample of 16 cases and 16 base base for the control group. taken. Inclusion criteria included nulliparous pregnant women at least literate, informed consent to participate in the study Exclusion criteria included known advanced gum disease or oral, occupation related to dentistry.Information both groups with standardized questionnaire that included questions on knowledge, HBM model and performance will be collected. At this stage of dental plaque index for both groups performed the index by a detector (fosion tablet or Disclosing) is measured in the mouth and areas of plaque formation on teeth show the way The tablets dissolve in the mouth in any part of the tooth that has plaque buildup that comes in pink plaque index formula and expressed as a percentage. After the needs assessment has been made at this stage and depending on the model designed for group intervention will be developed and implemented. After 3 months after educational intervention information from both groups were again collected by questionnaire and plaque index again be measured for both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015072423294N1
Registration date: 2015-08-21, 1394/05/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-21, 1394/05/30
Registrant information
Name
Abdolhosein Emami sigaroudi
Name of organization / entity
Guilan University of Medical Sciences،school of nursing & midwifery
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
emamisig@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-08-06, 1394/05/15
Expected recruitment end date
2015-10-07, 1394/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational program based on Health Belief Model on oral health behavior of pregnant women
Public title
Oral health behavior of pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : pregnant women nulliparous women ؛ at least to read and write ؛ an informed consent for the study .exclusion criteria : advanced gum disease ؛ oral knownunemployment associated with the dental profession
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences Vice Chancellor for Research and Technology
Street address
Gilan-Rasht-field gas-Martyr Beheshti Boulevard West-Opposite Bank Sepah-On behalf of Iran Radiator
City
Rasht
Postal code
41938-93345
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
IR.GUMS.REC.1394.75

Health conditions studied

1

Description of health condition studied
Oral health behavior of pregnant women
ICD-10 code
Z55.9
ICD-10 code description
Problem related to education and literacy, unspecified

Primary outcomes

1

Description
Oral health behavior of pregnant women
Timepoint
Before the intervention, three months after the intervention.
Method of measurement
Psychometric questionnaire based on HBM - dental plaque index with fuchsin tablet or Disclosing

Secondary outcomes

1

Description
Performance and plaque index
Timepoint
Before the intervention, three months after intervention
Method of measurement
Psychometric questionnaire based on HBM - dental plaque index with fuchsin tablet or Disclosing

Intervention groups

1

Description
Before intervention،information from groups with psychometric questionnaire in Iran collected by Heidarnia and colleagues. The plaque index is determined by research carried out in the presence of a dentist. The index, which through a detector material (fosion tablet or Disclosing) is measured in the mouth and areas of plaque formation on teeth show in this way that our teeth into four parts: top, back and sides expressed. After the needs assessment has been made at this stage and depending on the model designed for group intervention will be developed and implemented. The training program regarding the model mix (direct training includes group discussion, lecture, Q & A, film screenings and education indirect distribution and pamphlet and it was just the right message) will be executed for a month. After 3 months after intervention by questionnaire collected information about the group again and again for measured plaque index
Category
Prevention

2

Description
information from groups with psychometric questionnaire in Iran collected by Heidarnia and colleagues. The plaque index is determined by research carried out in the presence of a dentist. The index, which through a detector material (fosion tablet or Disclosing) is measured in the mouth and areas of plaque formation on teeth show in this way that our teeth into four parts: top, back and sides expressed . After 3 months by questionnaire collected information about the group again and again for measured plaque index
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Rasht
Full name of responsible person
Abdol hosein Emami sigarody-Sahar Nickbin poshtamsari
Street address
15 Health center in Rasht
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences, Research on the Social Determinants of Health
Full name of responsible person
Atefe GHanbari
Street address
Rasht - Highway martyr Beheshti - St. Student - Faculty of Nursing and Midwifery in Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences, Research on the Social Determinants of Health
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
Guilan University of Medical Sciences
Full name of responsible person
Rabiolla farmanbar
Position
PhD in health education and health promotion / Associate Professor, Faculty of Health،Guilan Univers
Other areas of specialty/work
Street address
Rasht - Highway martyr Beheshti - St. Student - Faculty of Nursing and Midwifery in Rasht
City
Rasht
Postal code
Phone
01333555056-33553202
Fax
+98 13 3355 0097
Email
emamisig@gmail.com s.nickbin@gmail.com Rabi_1345@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan university of medical sciences, School of Nursing & Midwifery
Full name of responsible person
Abdolhosein Emami Sigaroudi
Position
Doctor of Nursing
Other areas of specialty/work
Street address
Rasht - Highway martyr Beheshti - St. Student - Faculty of Nursing and Midwifery in Rasht
City
Rasht
Postal code
Phone
01333555056-33553202
Fax
+98 133328843
Email
emamisig@gmail.com s.nickbin@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
sahar nickbin poshtamsary
Position
Senior nursing student, health trends
Other areas of specialty/work
Street address
Rasht - Highway martyr Beheshti - Street Student - Faculty of Nursing and Midwifery in Rasht
City
Rasht
Postal code
Phone
01333555056-33553202
Fax
+98 13 3355 0097
Email
emamisig@gmail.com s.nickbin@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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