Protocol summary

Study aim
To compare the effect of two educational interventions on the awareness and self-reported performance of pregnant women regarding oral and dental health.
Design
semi-experimental clinical trial, two parallel intervention groups, 70 samples. Randomization will be performed for each center using SAS software version 9, and for randomization of individuals in each center into two groups, a 4-block permutation method will be used.
Settings and conduct
Setting: Private women's and maternity clinics in Islamshahr. Conduct: After random distribution between the two intervention groups, the first intervention will be received at the clinic. After that, both video content and brochures will be sent again to mothers every month through social networks. The awareness and self-reported performance of mothers in both groups will be assessed using an online questionnaire, once before the intervention, immediately after the intervention at the clinic, and three times at one-month, three-month, and six-month intervals after the intervention. Blinding: Single-blind, the data analyst will be unaware of the interventions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women who have access to one of the social networks (WhatsApp, Telegram, Eitaa, etc.). Exclusion criteria: Individuals who are in emergency situations or have unfavorable general conditions, or do not provide written informed consent.
Intervention groups
Group 1: Receiving educational intervention in the form of a text with images through a brochure. Group 2: Receiving educational intervention in the form of audio-visual content through a video.
Main outcome variables
Awareness of dental and oral health; self-reported dental and oral health performance.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160910029765N3
Registration date: 2023-10-24, 1402/08/02
Registration timing: prospective

Last update: 2023-10-24, 1402/08/02
Update count: 0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
Mohammad Reza Khami
Name of organization / entity
Tehran University of Medical Sciences, School of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5960
Email address
mkhami@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of two educational interventions including brochure or film on the awareness and self-reported performance of pregnant women regarding oral and dental health
Public title
Comparing the effect of educating pregnant women through brochure or film on oral and dental health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women Having access to one of the social networks such as WhatsApp, Telegram, Eitaa, etc
Exclusion criteria:
Emergency or unfavorable general conditions Not providing informed written consent
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Considering each district of Islamshahr as a cluster, clusters are selected, and then within each cluster, a private women's and maternity clinic is selected using simple random sampling. To randomize individuals in each center, a 4-block permutation block randomization method is used.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data collection tool is a self-administered anonymous questionnaire and only the participants know the confidential code which he/she writes in the baseline and follow up questionnaire to enable assessment of individual changes. All the data will be remained anonymous and confidential to the statistical analyst.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
End of North Kargar, School of Dentistry, Tehran University of Medical Sciences, Oral Health Department
City
Tehran
Province
Tehran
Postal code
Approval date
2023-07-18, 1402/04/27
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1402.040

Health conditions studied

1

Description of health condition studied
Awareness and self-reported performance of pregnant women regarding oral and dental health
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Awareness of oral and dental health
Timepoint
Before the intervention, immediately after the intervention, 1, 3, and 6 months after the intervention
Method of measurement
Baseline questionnaire and follow-up questionnaire

2

Description
Self-reported oral and dental health practice
Timepoint
Before the intervention, immediately after the intervention, 1, 3, and 6 months after the intervention
Method of measurement
Baseline questionnaire and follow-up questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: receiving educational intervention in the form of a text with images through a brochure
Category
Other

2

Description
Intervention group 2: receiving educational intervention in the form of audio-visual content through a video
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Private women's and maternity clinics in Islamshahr
Full name of responsible person
Mohammad Reza Khami
Street address
End of North Kargar, School of Dentistry, Tehran University of Medical Sciences, Oral Health Department
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
mkhami@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Keshavarz Blvd. Qods St. TUMS Headquarter, 6th floor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of North Kargar, School of Dentistry, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
mkhami@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of North Kargar, School of Dentistry, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
mkhami@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of North Kargar, School of Dentistry, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
mkhami@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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