The effect of education based on the locus of control theory on the puberty health and fertility of the first-grade female high school students of Faruj in 96
Determine the effect of education based on the locus of control theory on the puberty health and fertility of the first-grade girl students of Faruj
Design
The study method is a clinical trial with control group.At first, high school girls of the first grade will be divided into two urban areas (three schools) and a rural one (with three schools). In the second stage, we assume each school as one cluster in each region. Then, Two clusters are randomly chosen from the clusters. In the next step, each class (7th, 8th, and 9th grade) of selected schools will be assumed as a cluster. Finally, the students will be selected randomly from each cluster based on the attendance list.
Settings and conduct
Two girls' high schools are randomly selected and 53 students from each high school will be entered into the study. At first, the test and control groups complete the puberty and locus of control questionnaires. Then, the test group is trained in 5 sessions of puberty health and the control group does not receive any training.The questionnaires are completed immediately after the training by both groups and followed up 3 months later.
Participants/Inclusion and exclusion criteria
Entranc criteria:The desire to participate in the study Education at the 7th, 8th and 9th grade of the first grade high school ; Fluency in Farsi
Exclusion criteria: they are unable to answer questions For any reason;
Intervention groups
In this study, 7th, 8th and 9th grade girls are assigned to the test and control group. In the intervention group, the designed curriculum will consist of 5 sessions of theory training along with practical work and film screening on health of puberty and fertility. The control group does not receive any training.
Main outcome variables
Health of puberty and fertility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160710028863N33
Registration date:2019-04-16, 1398/01/27
Registration timing:retrospective
Last update:2019-04-16, 1398/01/27
Update count:0
Registration date
2019-04-16, 1398/01/27
Registrant information
Name
Nooshin Peyman
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 502 6195
Email address
peymann@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on the locus of control theory on the puberty health and fertility of the first-grade female high school students of Faruj in 96
Public title
The effect of education based on the locus of control theory on the puberty health and fertility of the first-grade female high school students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Education at the 7th, 8th and 9th grade of the first grade high school
Fluency in Farsi
Exclusion criteria:
they are unable to answer questions For any reason
Age
From 12 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the first grade female high school will be divided into two urban areas (three schools) and a rural one (with three schools). In the second stage, each school will be assumed as one cluster and then be selected from the clusters by simple random sampling two clusters.In the next step,the selected schools will be assumed one class(7th, 8th & 9th grade) as a cluster and finally, the students are selected from each cluster based on the attendance list by simple random method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences School of Health
Street address
School of Health, Mashhad University of Medical Science, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9137673119
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR.MUMS.REC.1397.201
Health conditions studied
1
Description of health condition studied
Puberty health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Health of puberty and fertility
Timepoint
Before the intervention, immediately and 3 months after the intervention
Method of measurement
knowledge and performance of puberty questionnaire
2
Description
Health Locus of control score
Timepoint
Before the intervention, immediately and 3 months after the intervention
Method of measurement
Waltzton Health Locus of Control questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The curriculum included 5 sessions of 45-minute group instructional theoretical and practical training along with the presentation of films on puberty health and the locus of control. According to the locus of control theory, first was introduced by Rutter, people's belief in their ability to control their outcomes is measured. The orientation of individuals’ locus of control is defined as a attribution of success or failure to internal or external factors. Individuals with an internal control source believe that they have a serious control over their lives and behave based on it. But individuals with external orientation believe that their successes and failures are governed by external factors such as destiny, luck, powerful people and unpredictable environmental forces.
Category
Behavior
2
Description
"Control group": this group will not receive any intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
First grade female High School in Farouj
Full name of responsible person
Dr Nooshin Peyman
Street address
Daneshgah18,Daneshgah street, The Faculty of Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3851 4548
Fax
+98 51 3852 2775
Email
Peymann@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University Street, opposite University of Mashhad, 18Vice-Chancellor for Research ,Mashhad University of Medical Sciences,In front of Daneshgah18,Daneshgah Street,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Nooshin Peyman
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Daneshgah18,Daneshgah Street,The faculty of Health,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3851 4548
Fax
+98 51 3852 2775
Email
Peymann@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Nooshin Peyman
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Daneshgah18,Daneshgah street,The faculty of Health,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3851 4548
Fax
+98 51 3852 2775
Email
Peymann@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Nooshin Peyman
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Daneshgah18,Daneshgah Street,The faculty of Health,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3851 4548
Fax
+98 51 3852 2775
Email
Peymann@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Potential data is sharable after distinguishing people.
When the data will become available and for how long
Starting the access period one month after the publication of result
To whom data/document is available
Researchers who work at the university.
Under which criteria data/document could be used
The data is sent via an official request and by email.
From where data/document is obtainable
Dr Nooshin Peyman Peymann@mums.ac.ir
What processes are involved for a request to access data/document
The data is sent via an official request and by email.