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The effect of educational intervention based on protection–motivation theory on oral health literacy promotion among female high school students

Protocol summary

Summary
This study is an educational randomized controlled trial. The purpose of this study is to determine the effect of educational intervention based on protection motivation theory on oral health literacy promotion. 180 students are selected by a multistage cluster sampling from four secondary schools of the zone 2 and 4 of Shiraz education after elimination of special schools (gifted, non-profit and exceptional) and assign into experimental and control groups. The data is obtained by using oral health literacy and protection motivation theory questionnaire before and after the educational intervention. Inclusion criteria are being female students studying at ninth grade of high school in Shiraz and willingness to participate in the study and exclusion criteria are unwillingness to continue participating in research, absence in the pre-test or post-test, absence of more than one session in educational classes and incomplete filling of questionnaires. Educational intervention include four educational sessions of 45 to 60 minutes once a week based on booklet " be the best friend of your teeth" Which has been prepared by reviewing of the literature and the results of pre-test questionnaire analysis and are perform by lecture, question and answer, group discussion, role playing, video playback, training booklet and poster in intervention group. Primary research outcomes are oral health literacy, behavior and teeth plaque index, and secondary outcome are Protection Motivation Theory components (perceived vulnerability, perceived severity, self-efficacy, response efficacy and response costs) and knowledge.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201702176261N16
Registration date: 2017-07-12, 1396/04/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-12, 1396/04/21
Registrant information
Name
Mohammad Hussein Kaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
kaveh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences, Governmental
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on protection–motivation theory on oral health literacy promotion among female high school students
Public title
The effect of educational intervention on oral health literacy promotion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: female students studying at the base of the ninth school Junior High School Shiraz willingness to cooperate in the study Exclusion criteria: study in special schools (gifted, non-profit and exceptional), unwillingness to cooperate, participate in the pre-test or post-test; absence of more than one meeting during the classes, withdrew from the study, a questionnaire corruption due to incomplete answer.
Age
From 14 years old to 15 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples were divided into intervention and control groups using closed envelopes.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice chancellor for research, seventh floor, Shiraz University Center Building, Zand Avenue
City
Shiraz
Postal code
7134814336
Approval date
2017-01-08, 1395/10/19
Ethics committee reference number
IR.SUMS.REC.1395.166

Health conditions studied

1

Description of health condition studied
Oral Health Literacy
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services

Primary outcomes

1

Description
Oral Health Literacy
Timepoint
Before the intervention and one month after educational intervention
Method of measurement
Oral Health Literacy questionnaire

2

Description
Plaque Index
Timepoint
Before the intervention and one month after intervention
Method of measurement
silness loe plaque index

3

Description
Oral health behavior
Timepoint
Before the intervention and one month after educational intervention
Method of measurement
Self-Made Protection Motivation Theory questionnaire

Secondary outcomes

1

Description
Perceived vulnerability
Timepoint
Before the intervention and one month after intervention
Method of measurement
Self-Made Protection Motivation Theory questionnaire

2

Description
perceived severity
Timepoint
Before the intervention and one month after intervention
Method of measurement
Self-Made Protection Motivation Theory questionnaire

3

Description
Self-efficacy
Timepoint
Before the intervention and one month after intervention
Method of measurement
Self-Made Protection Motivation Theory questionnaire

4

Description
Response Efficacy
Timepoint
Before the intervention and one month after intervention
Method of measurement
Self-Made Protection Motivation Theory questionnaire

5

Description
response costs
Timepoint
Before the intervention and one month after intervention
Method of measurement
Self-Made Protection Motivation Theory questionnaire

6

Description
Knowledge
Timepoint
Before the intervention and one month after intervention
Method of measurement
Self-Made Protection Motivation Theory questionnaire

Intervention groups

1

Description
Intervention group: educational intervention included 4 educational sessions of 45 to 60 minutes once a week based on booklet " Be the best friend of your teeth" and are performed by lecture, question and answer, group discussion, role playing, video playback, training booklet and poster.
Category
Behavior

2

Description
Control group: In the control group, educational intervention does not take place. These group will participate in the pre-test and post-test.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Narjes girls' High School
Full name of responsible person
Fatemeh Movasseghi
Street address
Nasr Blvd, Shiraz
City
Shiraz

2

Recruitment center
Name of recruitment center
Enghelab Eslami girls' High School
Full name of responsible person
Fatemeh Movasseghi
Street address
Saheli Sharghi Avenue, Shiraz
City
Shiraz

3

Recruitment center
Name of recruitment center
Shahid Nematolahi girls' High School
Full name of responsible person
Fatemeh Movasseghi
Street address
Zakaolmolk Avenue, Shiraz
City
Shiraz

4

Recruitment center
Name of recruitment center
Olum va Maaref girls' High School
Full name of responsible person
Fatemeh Movasseghi
Street address
Parvaneh Alley, Zand Avenue, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Sayed Basir Hashemi
Street address
Vice chancellor for research, seventh floor, Shiraz University Center Building, Zand Avenue
City
Shiraz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shiraz 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
Shiraz University of Medical sciences
Full name of responsible person
Fatemeh Movasseghi
Position
Master Student of Health Education
Other areas of specialty/work
Street address
Health education and health promotion,School of Public Health , Shiraz University of Medical sciences
City
Shiraz
Postal code
14336 71348
Phone
+98 71 3725 1001
Fax
Email
stud2296951880@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Mohamad Hosein Kaveh
Position
Associate Professor
Other areas of specialty/work
Street address
Health education and health promotion,School of Public Health , Shiraz University of Medical sciences
City
Shiraz
Postal code
14336 71348
Phone
+98 71 3725 1001
Fax
Email
kaveh@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Movasseghi
Position
Master Student of Health Education
Other areas of specialty/work
Street address
Health education and health promotion,School of Public Health , Shiraz University of Medical sciences
City
Shiraz
Postal code
14336 71348
Phone
+98 71 3725 1001
Fax
Email
stud2296951880@sums.ac.ir
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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