Protocol summary
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Study aim
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The main goal is determining the effect of multimedia puberty health education on body image and self-esteem for male students in the middle school.
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Design
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participants were selected using random sampling method. Between high schools at Ilam city 2 ones were chose randomly after that among 2 selected high schools one of them as intervention group and the other one as control group were selected. In general, there were 58 students in intervention group and 60 students in control group.
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Settings and conduct
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Intervention program was included of 4 sections which each section was 60 minutes time duration. Educational content teaching Was conducted by using a researcher self-made compact disc. The used tools which were used in order to gathering information were Multidimensional Body Self-Relation Questionnaire, Rosenberg self-esteem questioner and personal profile. The mentioned resources during 3 stages were presented to the samples (before, immediately after and 3 months after education). After gathering information, they were analyzed by SPSS software.
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Participants/Inclusion and exclusion criteria
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Criterions of this study are as follow:
• Iranian nationality
• Living with original family (stepchild not included)
• None history of presenting a puberty education
• Full physical and mental health
• Without facing any kind of nervous experience
• Parents should not be educated in psychological, educational or medical sciences
Criterions of sample rejection are as follow:
• Being absent more than one section of educational courses
• Occurring nervous accident during study or 3 months at the end of Educational intervention
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Intervention groups
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Puberty health program runs in the intervention group.About control group any type intervention won’t be performed.
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Main outcome variables
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-Self esteem
- Body image
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170822035833N1
Registration date:
2017-12-07, 1396/09/16
Registration timing:
registered_while_recruiting
Last update:
2018-07-16, 1397/04/25
Update count:
1
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Registration date
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2017-12-07, 1396/09/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Investigator
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Expected recruitment start date
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2017-10-23, 1396/08/01
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Expected recruitment end date
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2018-03-22, 1397/01/02
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Actual recruitment start date
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2017-11-25, 1396/09/04
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Actual recruitment end date
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2018-04-04, 1397/01/15
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Trial completion date
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empty
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Scientific title
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The Investigation of Multimedia Puberty Health Education on Body Image and Self-esteem for Male Students in The Middle School
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Public title
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The Investigation of Multimedia Puberty Health Education on Body Image and Self-esteem for Male Students in The Middle School
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Iranian nationality
Living with original family (stepchild not included)
None history of educational leap or failing a hole year
None history of presenting a puberty education
Full physical and mental health
Without facing any kind of nervous experience
Parents should not be educated in psychological, educational or medical sciences
Exclusion criteria:
Being absent more than one section of educational courses
Occurring nervous accident during study or 3 months at the end of Educational intervention
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Age
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No age limit
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
112
Actual sample size reached:
118
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Between high schools at Ilam city 2 ones were chose randomly after that among 2 selected high schools one of them as intervention group and the other one as control group were select.After that two classes were chosen randomly through seconds grade ones which all their students were participate in intervention. The control group selection method was same as intervention group method.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-07-12, 1396/04/21
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Ethics committee reference number
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IR.IUMS.FMD.REC۱۳۹۶.۹۴۱۱۳۷۳۰۱۰
Health conditions studied
1
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Description of health condition studied
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health education
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ICD-10 code
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z71.9
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ICD-10 code description
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medical advice NOS
Primary outcomes
1
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Description
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body image
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Timepoint
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before, immediately after and 3 months after education
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Method of measurement
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Multidimensional Body Self-Relation Questionnaire
2
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Description
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self-esteem
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Timepoint
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before, immediately after and 3 months after education
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Method of measurement
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Rosenberg self-esteem questioner
Intervention groups
1
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Description
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intervention program was included of 4 sections with 60 minutes time duration which each section were held for boy students with 14-15 members separately. Content of each section consisted of such titles like Puberty physical and mental changes - Anatomy and Physiology of male reproductive system- Puberty health - sexual transmitted diseases - high risk behaviors- Nutrition - exercise - Life skills –self-esteem and body image.
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Category
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Prevention
2
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Description
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About control group any type intervention were not performed.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Part of the data is related to the main outcome is Publishable.
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When the data will become available and for how long
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The beginning of the access period is 6 months after the publication of the results.
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To whom data/document is available
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Use for everyone is free
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Under which criteria data/document could be used
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There are no specific conditions for using data.
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From where data/document is obtainable
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mahsa alimohammadi
email: mahsa71al@gmail.com
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What processes are involved for a request to access data/document
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There is no specific process.
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Comments
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