Objective: provide simple administrative solutions in order to create attitudes and behavior in order of importance of oral health.
Field of study: randomized, double-blind, placebo-uncontrolled, multi-center, one phase of clinical trial.
A) Study population: male and female students in primary schools (fourth, fifth and sixth) at saveh city.
Inclusion criteria: willingness to participate in the study; fourth to sixth primary school students; without learning disorders such as ADHD and autism; Without attending similar training.
Exclusion criteria: reluctance to continue to participate in the study; school managers opposing to participate of students in the study; reluctance of parents to participate of students in the study.
Sample size: 520, with the possibility of sample loss.
B) Intervention study: the effect of planned behavioral theory training on behaviors that associated with mouth and tooth health in primary students
C) The study period: from 10 March 2017 to 30 May 2017.
D) The primary outcome: the creation of a positive attitude about the importance of oral health.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017012831522N5
Registration date:2017-02-20, 1395/12/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Vahid Naseri Salahshour
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
v.naserisalahshour@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Saveh University of Medical Sciences
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2017-05-10, 1396/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of planned behavioral theory training on behaviors that associated with mouth and tooth health in primary students
Public title
The effect of education According to planned behavioral theory on mouth and tooth health in primary students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; fourth to sixth primary school students; without learning disorders such as ADHD and autism; without attending similar training.
Exclusion criteria: reluctance to continue to participate in the study; school managers opposing to participate of students in the study; reluctance of parents to participate of students in the study; irregular participation in training classes.
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
520
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples were randomly placed in two groups.
If the first sample is girl, the sample placed in intervention group and after the samples alternative (one to one) placed in control and intervention groups and if the first sample is boy, the sample placed in control group and after the samples alternative (one to one) placed in intervention and control groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Saveh University of Medical Sciences
Street address
Saveh University of Medical Sciences, Madar Sq, SHariati St, Saveh
City
Saveh
Postal code
3918698786
Approval date
2015-07-26, 1394/05/04
Ethics committee reference number
IR.SAVEHUMS.REC139407
Health conditions studied
1
Description of health condition studied
Mouth and tooth health
ICD-10 code
Z41.8
ICD-10 code description
Other procedures for purposes other than remedying health state
Primary outcomes
1
Description
Observance of mouth and tooth health
Timepoint
The questionnaire immediately after the intervention and one month after it is completed by samples of two experimental and control groups
Method of measurement
The seven-part questionnaire including: knowledge, attitude, subjective norm, perceived behavioral control, intention and behavior
Secondary outcomes
empty
Intervention groups
1
Description
Intervention groups: The samples of intervention group training at 3 sessions of 40 minutes in the form of lectures, group discussions and practical view.
Educational content classes includes:
First session: raising awareness and attitude,
Second session: the importance of perceived behavioral control on empowerment
And third Session: Practical showing the correct way of brushing and flossing and practice on themselves.
Category
Behavior
2
Description
Control group: samples of the control group as well as samples of the intervention group (without participation in the educational classes) to complete the questionnaires.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Saveh city primary schools
Full name of responsible person
The managers of saveh city primary schools
Street address
Saveh city department of education, Fajr town entrance, SHahid Beheshti Blvd, Saveh.
City
Saveh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Saveh University of Medical Sciences
Full name of responsible person
Hamidreza Baradaran, Vice Chancellor for research of Saveh University of Medical Sciences
Street address
Saveh University of Medical Sciences, Madar Sq, SHariati st, Saveh
City
Saveh
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 Saveh 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
Saveh University of Medical Sciences
Full name of responsible person
Vahid Naseri Salahshour, MSc of Nursing Education in Medical Surgical Field
Position
MSc of Nursing Education in Medical Surgical Field
Other areas of specialty/work
Street address
Saveh University of Medical Sciences, Madar Sq, SHariati st, Saveh
City
Saveh
Postal code
3918698786
Phone
+98 86 4230 1291
Fax
-
Email
v.naserisalahshour@arakmu.ac.ir
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Vahid Naseri Salahshour (MSc of Nursing Education in Medical Surgical Field)
Position
MSc of Nursing Education in Medical Surgical Field
Other areas of specialty/work
Street address
Saveh University of Medical Sciences, Madar Sq, SHariati st, Saveh
City
Saveh
Postal code
3918698786
Phone
+98 86 4230 1291
Fax
-
Email
v.naserisalahshour@arakmu.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Vahid Naseri Salahshour (MSc of Nursing Education in Medical Surgical Field)
Position
MSc of Nursing Education in Medical Surgical Field
Other areas of specialty/work
Street address
Saveh University of Medical Sciences, Madar Sq, SHariati st, Saveh
City
Saveh
Postal code
3918698786
Phone
+98 86 4230 1291
Fax
-
Email
v.naserisalahshour@arakmu.ac.ir
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)