Protocol summary

Summary
This study has been designed in 1394 to determine the effect of counseling with mothers and the function and Awareness of high school adolescent girls about reproductive health in the Hamadan city. Sampling is done inform of blocking,the study population will comprise all mothers and school`s adolescent girls. Inclusion criteria: girls 13-16 years old; the occurrence of menarche; being single; living with parents; mothers: Physical and mental health and the absence of drug`s Consumption.Exclusion criteria:Girls:marriage; separation From parents; transfer to the another school during the study; the occurrence of physical and mental illness during The study: mothers lacking of participation in training Sessions .The volume of sample: 60 persons in the intervention group and the 60 persons in the control group have been determined. Reproductive health teaching in The intervention group will be carried out during 4 session by the researcher. The main outcome variable in this study is the awareness and operation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015082623640N3
Registration date: 2016-04-19, 1395/01/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-19, 1395/01/31
Registrant information
Name
Farzaneh Soltani
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 813220683
Email address
soltani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Research Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of maternal advice and knowledge about the practice of female reproductive health
Public title
The effect of maternal advice and knowledge about the practice of female reproductive health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Girls: age 13-16 years; the occurrence of menarche; being single; living with parents; physical and mental health. Maternal: physical and mental health of mothers and no drugs. exclusion criteria: Girls: Marriage; Separation from parents;Transfer to another school. Mothers: Physical or mental illness; failure to attend training classes
Age
From 13 years old to 16 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling will be done in the case of double stage clustering sampling. In the first stage, 8 schools from two district of educating of Hamadan( each district has consisted of Four schools) elected in the case of simple random sampling, in the second stage from every elected school with use of student`s lists and the table of random numerals from each degree elected 5 students randomly.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences
City
Hamadan
Postal code
65178
Approval date
2015-08-16, 1394/05/25
Ethics committee reference number
1394.255 IR.UMSHA.REC

Health conditions studied

1

Description of health condition studied
Knowledge and adolescent reprodactive health
ICD-10 code
z00.3
ICD-10 code description
Examination for adolescent development state Puberty development state

Primary outcomes

1

Description
Awareness of reproductive health
Timepoint
Before and three months after intervention
Method of measurement
Adolescent Reproductive Health QuestionnaireWHO

2

Description
Performance reproductive health
Timepoint
Before and three months after intervention
Method of measurement
Adolescent Reproductive Health Questionnaire WHO

Secondary outcomes

1

Description
Counseling mothers
Timepoint
Before and three months after intervention
Method of measurement
Checklist

Intervention groups

1

Description
The intervention group: Teaching the mothers in 4 sessions will take 60 minutes and the number of the participants in each session will be 10-12 person. They will receive thenecessary advice about different aspects of reproductive health. The content of counsulting sessions consist of some information about genitali anatomy, fertility`s Physiology and menstration,menstruation hygiene and its complications, nutrition of adolescence period. The source of information is about reproductive health.
Category
Other

2

Description
The control group will not be intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Somaye govermental girlie school
Full name of responsible person
Fattahy Zainab
Street address
Rokni street
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of Research Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Bashirian Saeed
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research Technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Farzaneh Soltani
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave, Hamadan
City
Hamadan
Postal code
6516845977
Phone
+98 81 3827 6051
Fax
Email
Farzanehsoltani2008@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farzaneh Soltani
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Hamadan University of Medical sciences, School of Nursing and Midwifery, Fahmideh Ave, Hamadan
City
Hamadan
Postal code
6516845977
Phone
+98 81 3827 6051
Fax
Email
Farzanehsoltani2008@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farzaneh Soltani
Position
PhD in Reproductive Health / Assistant
Other areas of specialty/work
Street address
Fahmideh Street, Hamadan Universiy of Medical Sciences
City
Hamadan
Postal code
6516845977
Phone
+98 81 3827 6051
Fax
Email
Farzanehsoltani2008@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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