The effect of an educational program based on Pender's health promotion model on the frequency and duration of toothbrushing among pregnant women: Application of social networks
The effect of an educational program based on Pender's health promotion model on the frequency and duration of toothbrushing among pregnant women using social networks
Design
104 pregnant women who meet the inclusion criteria will be randomly assigned to intervention and control groups (control group: 52 and intervention group: 52 ). The pre-test will be completed by both groups. Three months after the intervention, the post-test will be completed in both groups.
Settings and conduct
The study will be conducted among pregnant women with records at Arak health centers. The intervention group will receive training through the social network. In the present study, blinding will be done regarding the participants and statistical investigator.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a record in one of the health centers of Arak city, gestational age under 12 weeks, age between 16 and 46 years, ability to use social network
Exclusion criteria: abortion, premature birth, complicated problems during pregnancy, reluctance to continue participation in the study
Intervention groups
The intervention group will receive the educational program based on Pender's health promotion model for three months through social network. The control group will receive trainings on self-care during pregnancy.
Main outcome variables
toothbrushing behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221228056955N1
Registration date:2023-01-17, 1401/10/27
Registration timing:prospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Maryam Barati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3727 5830
Email address
barati85@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational program based on Pender's health promotion model on the frequency and duration of toothbrushing among pregnant women: Application of social networks
Public title
The effect of educational program on oral health in pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a pregnancy record in one of the health centers of Arak
Gestational age under 12 weeks
Age 16 to 46 years
Ability to use social networks
Exclusion criteria:
Abortion
Preterm birth
complicated problems during pregnancy
Reluctance to continue participation in the study
Age
From 16 years old to 46 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Since the city of Arak is divided into five municipal districts, the health centers were also divided into five parts according to these districts. Some of the health centers were randomly selected from each of the districts depending on their scope and population. The selected centers were randomly assigned to the control group (20 centers) and the intervention group (19 centers).Finally, due to the small number of pregnant women in the first trimester in each center, pregnant women who meet the inclusion criteria will be included in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study participants do not know that they were in the control or intervention groups.
The statistical investigator do not know that the data is related to the control or intervention groups.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Committee of Hamadan University of Medical Sciences
Street address
Health Faculty, Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
8138380509
Approval date
2021-01-09, 1399/10/20
Ethics committee reference number
IR.UMSHA.REC.1399.863
Health conditions studied
1
Description of health condition studied
Oral health including the frequency and duration of tooth brushing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Constructs of Pender's Health Promotion Model
Timepoint
Before and three months after the intervention
Method of measurement
Researcher made questionnaire
Secondary outcomes
1
Description
Tooth brushing behavior including frequency and duration of tooth brushing
Timepoint
Before and three months after the intervention
Method of measurement
Researcher made questionnaire
Intervention groups
1
Description
Intervention group: In this study, educational intervention will be done through social network. The educational intervention will be conducted from 12 to 28 weeks of pregnancy (3 months).Then the women will be followed up for 3 months.
Category
Behavior
2
Description
Control group: The control group will receive the educational program including self-care during pregnancy (topics except oral hygiene and related issues) through social network.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Arak city
Full name of responsible person
Shariar Hoseini
Street address
Shahid Beheshti Phase 2, Hepko Street, Arak,Iran.
City
Arak
Province
Markazi
Postal code
3177-8-38189
Phone
+98 83 3313 9035
Fax
Email
arakmarkazi@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/arakdh/fa/page/1927
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Health Faculty, Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamadan, Iran.
City
Arak
Province
Markazi
Postal code
8138380509
Phone
+98 83 3727 5830
Email
Fanavari@umsha.ac.ir
Web page address
https://research.umsha.ac.ir
Grant name
Grant code / Reference number
9904242558
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Barati
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Health Faculty, Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamadan, Iran. Postal Code: 8138380509
City
Hamadan
Province
Hamadan
Postal code
8138380509
Phone
+98 83 3727 5830
Fax
+98 83 3838 0509
Email
barati85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Barati
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Maryam Barati, Health Faculty, Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamadan, Iran. Phone: +98 9186030112. barati85@gmail.com.
City
Hamadan
Province
Hamadan
Postal code
8138380509
Phone
+98 83 3727 5830
Fax
+98 83 3838 0509
Email
barati85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Barati
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Maryam Barati, Health Faculty, Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamadan, Iran. Phone: +98 9186030112. barati85@gmail.com.
City
Hamadan
Province
Hamadan
Postal code
8138380509
Phone
+98 83 3727 5830
Fax
+98 83 3838 0509
Email
barati85@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data related to questionnaire and anonymous demographic information.
When the data will become available and for how long
Access to data after publication of results
To whom data/document is available
The data will be available for researchers.
Under which criteria data/document could be used
Using data to conduct meta-analysis studies
From where data/document is obtainable
The applicant can receive the data and documents by sending an email to barati85@gmail.com.
What processes are involved for a request to access data/document
After receiving the email and reviewing the request, the data will be available to the requester within a week.