Protocol summary

Summary
The purpose of this study was to determine the effect of an educational intervention based on Pender’s Health Promotion Model on oral health among pregnant women in Hamadan city. In this study 128 pregnant women from 8 health centers in Hamadan city were randomly allocated to intervention (4 health centers and 64 women) and control (4 health centers and 64 women) groups. Inclusion criteria: being satisfied to participate in the study, having an active health record in the health center, and being in the first trimester. Exclusion criteria: absence from educational sessions more than twice, migration, and ending the pregnancy during intervention. The main intervention included three 45- minute sessions and a booklet in order to provide information and motivation to change in Pender’s model construct. After 45 days of last session, a reminder of 8 informational and motivational text messages was offered to women of intervention group during 4 days (9 am, and 7 pm). Information about the individual characteristics, constructs of Pender’s Health Promotion Model, and women’s oral health behaviors (brushing before sleeping, brushing after each meal, and brushing after eating sweets) was collected by questionnaire before intervention, immediately after sessions and 3 months after sessions in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013080212456N3
Registration date: 2013-08-15, 1392/05/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-15, 1392/05/24
Registrant information
Name
Akram Karimi-Shahanjarini
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0583
Email address
karimi.a@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-02-23, 1391/12/05
Expected recruitment end date
2013-03-18, 1391/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational program based on Pender’s Health Promotion Model on oral health among pregnant women in Hamadan city
Public title
Oral health and pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: being satisfied to participate in the study; having an active health record in the health center, and being in the first trimester Exclusion criteria: absence from educational sessions more than twice; migration, and ending the pregnancy during intervention.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 128
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
Hamadan University of Medical Science
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave Hamadan
City
Hamadan
Postal code
Approval date
2013-02-19, 1391/12/01
Ethics committee reference number
d/p/16/35/9/1051

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
Z80-99
ICD-10 code description
Persons with potential health hazards related to family and personal history and certain conditions influencing health status

Primary outcomes

1

Description
Perceived benefits
Timepoint
Baseline,immediately after intervention and 3 months after intervention
Method of measurement
Questionnaire

2

Description
Perceived barriers
Timepoint
Baseline,immediately after intervention and 3 months after intervention
Method of measurement
Questionnaire

3

Description
Perceived self efficacy
Timepoint
Baseline,immediately after intervention and 3 months after intervention
Method of measurement
Questionnaire

4

Description
Affect related to behavior
Timepoint
Baseline,immediately after intervention and 3 months after intervention
Method of measurement
Questionnaire

5

Description
Interpersonal influences
Timepoint
Baseline,immediately after intervention and 3 months after intervention
Method of measurement
Questionnaire

6

Description
Commitment to plan of action
Timepoint
Baseline,immediately after intervention and 3 months after intervention
Method of measurement
Questionnaire

7

Description
Pattern
Timepoint
Baseline,immediately after intervention and 3 months after intervention
Method of measurement
Questionnaire

8

Description
brushing before sleeping
Timepoint
Baseline, 3 months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Brushing after each meal
Timepoint
Baseline, 3 months after intervention
Method of measurement
Questionnaire

2

Description
Brushing after eating sweets
Timepoint
Baseline, 3 months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
The main intervention included three 45- minute sessions and a booklet in order to provide information and motivation to change in Pender’s model construct. After 45 days of last session, a reminder of 8 informational and motivational text messages was offered to women of intervention group during 4 days (9 am, and 7 pm).
Category
Prevention

2

Description
Control group: no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Karrbasian
Full name of responsible person
Street address
City
Hamedan

2

Recruitment center
Name of recruitment center
Ghods
Full name of responsible person
Street address
City
Hamedan

3

Recruitment center
Name of recruitment center
Shohada
Full name of responsible person
Street address
City
Hamedan

4

Recruitment center
Name of recruitment center
Morad beyg
Full name of responsible person
Street address
City
Hamedan

5

Recruitment center
Name of recruitment center
Joulan
Full name of responsible person
Street address
City
Hamedan

6

Recruitment center
Name of recruitment center
Emam Hosein
Full name of responsible person
Street address
City
Hamedan

7

Recruitment center
Name of recruitment center
Sameei 3
Full name of responsible person
Street address
City
Hamedan

8

Recruitment center
Name of recruitment center
Sameei 10
Full name of responsible person
Street address
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Ahmad Tavilani
Street address
Hamedan University of Medical Sciences
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-chancellor of Research and Technology, Hamadan 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
Hamedan University of Medical Sciences
Full name of responsible person
Akram Karimi
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1838 0583
Fax
Email
karimi.a@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Akram Karimi
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81118380509
Fax
Email
karimi.a@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Akram Karimi
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
00
Fax
Email
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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