Protocol summary

Summary
Objectives; Evaluation of the effect of educational intervention based on Pender’s Health Promotion Model on oral and dental health behaviors among high school students in Talish city. Design; This study is a random control trial that was carried out on 172 high school students, using two-stage sampling method in Talish city, in 2014. Setting and conduct; Samples were divided randomly into two groups, control and intervention. Data collection tool was a validity and reliability assessed questionnaire, designed on the Health Promotion Model. Educational intervention was designed based on the data collected from pre-test and carried out in five 50 to 60-minute sessions within four weeks on intervention group. Post-test data were collected two weeks and three months after educational intervention and were analyzed in SPSS 18 software, using statistic tests including independent T-tests, Mann-whithneyu, Wilcoxon, Paired t-tests, ANOVaand Chi-square. Inclusion criteria; Voluntary participating in study, Studying in 2nd grade of high school Exclusion criteria; The fail of the participating in each of the training sessions,The lack of consent to continue in study. Main outcome; improving the students' oral health behaviors

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014062618248N1
Registration date: 2014-10-25, 1393/08/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-10-25, 1393/08/03
Registrant information
Name
Maryam Pourhallaji
Name of organization / entity
Guilan University of medical sciences and health care services
Country
Iran (Islamic Republic of)
Phone
+98 13 4422 0386
Email address
maryampourhallaji@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan university of medical sciences and health care services
Expected recruitment start date
2014-06-04, 1393/03/14
Expected recruitment end date
2016-03-02, 1394/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on Pender’s Health Promotion Model on oral and dental health behaviors among high school students
Public title
The effect of educational intervention based on Pender’s Health Promotion Model on oral and dental health behaviors among high school students in
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Voluntary participating in study, Studying in 2nd grade of high school Exclusion criteria: The fail of the participating in each of the training sessions, The lack of consent to continue in study
Age
From 16 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 172
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
Vice chancellor for research, Guilan University of medical sciences and health care services
Street address
Vice chancellor for research, Guilan University of medical sciences and health care services, Shahid beheshti Gharbi bulevard, Gaz Square
City
Rasht
Postal code
4193893345
Approval date
2014-06-02, 1393/03/12
Ethics committee reference number
4930111205

Health conditions studied

1

Description of health condition studied
Oral health behaviors
ICD-10 code
Z72.9
ICD-10 code description
Problem related to lifestyle, unspecified

Primary outcomes

1

Description
Dental Plaque
Timepoint
before intervention, two weeks after intervention, three months after intervention
Method of measurement
Dental examinathon

2

Description
Oral Health behavior
Timepoint
before intervention, two weeks after intervention, three months after intervention
Method of measurement
Questionare

Secondary outcomes

1

Description
tooth brushing
Timepoint
before intervention, two after intervention, three months after intervention
Method of measurement
questionair, check list

Intervention groups

1

Description
Control; no intervention
Category
Lifestyle

2

Description
Intervention group; Educational intervention was designed based on the data collected from pre-test and carried out in five 50 to 60-minute sessions within four weeks.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Azadi high school of Talesh
Full name of responsible person
Jamile Jafari
Street address
Khoramshahr Street
City
Talesh

2

Recruitment center
Name of recruitment center
Efaf high school Of Talesh
Full name of responsible person
Zeinab Balazade
Street address
Moalem street, Taleghani Street
City
Talesh

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heydarzade
Street address
Vice Chancellor for research of Guilan University of Medical Sciences, Shahid Beheshti Gharbi Bulevard, Gaz Square
City
rasht
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 Guilan 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
Guilan university of medical sciences and health care services
Full name of responsible person
Maryam Pourhallaji
Position
Student
Other areas of specialty/work
Street address
No 38, Moalem Street
City
Talesh
Postal code
4371967835
Phone
+98 134420386
Fax
Email
mbdsh86703@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan university of medical sciences and health care services
Full name of responsible person
Parisa kasmai
Position
Instructor, Member of the academic staff
Other areas of specialty/work
Street address
Shahid Siadati Street, Namjou Street, Rasht
City
Rasht
Postal code
Phone
+1 313234154
Fax
www.gums.ac.ir
Email
parisak81@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences and health services
Full name of responsible person
Maryam Pourhallaji
Position
Student
Other areas of specialty/work
Street address
No 38, Moalem Street
City
Talesh
Postal code
4371967835
Phone
+98 13 4422 0386
Fax
Email
mbdsh86703@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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