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The impact of counseling based on protection motivation theory on self care of teenage girls reproductive health

Protocol summary

Study aim
Determining the Effect of counseling based on protective motivation theory on reproductive health self care of girl adolescent students in Alborz university Of Medical Sciences
Design
Clinical trials with a control group, community based and pragmatic, with parallel,Not blind , randomized groups
Settings and conduct
The study will be conducted on the girl students of the Alborz University of Medical Sciences. The colleges will be selected by cluster sampling, and then from among eligible girl students, the sample will be determined. Initially, the researcher will go to the relevant colleges, and the students will meet the entry criteria Identifies. Then the goals of the study are expressed to them and if they are willing to participate in the study, they will receive written consent. Subjects will be randomly assigned to two intervention and control groups according to the random numbers table. The intervention group has six counseling sessions With protective motivational approach, each one will receive 90 minutes . Meetings will be held once a week
Participants/Inclusion and exclusion criteria
Inclusion criteria: single,girl,first or second year of university,Maximum 21 years old ; mental illnesses
Intervention groups
The intervention group will receive six counseling sessions with a protective motivational approach for 90 minutes each. Meetings will be held once a week. The teaching method will be group discussion, question and answer, and role play. Immediately after the end of the session and then one month after the end of the interventions, the questionnaire will be completed by the group members
Main outcome variables
Determine rate of reproductive health self-care adolescent girls in the intervention group before, after and one month after counseling Determine rate of reproductive health self-care adolescent girls in the control group before, one month after counseling Comparison rate of reproductive health self-care in adolescents in two groups Determine rate of reproductive health self-care adolescent girls based on self efficacy before, after and one month after counseling Determination of self-care level of teenagers' reproductive health based on Perceived response efficiency in intervention group before, after and one month after counseling Determination of self-care level of reproductive health in adolescent girls based onperceived vulnerability in intervention group before, after and one month after counseling Determination of self-care fertility in adolescent girls based on severity of perception in intervention group before, after and one month after counseling. Determination of self-care level of reproductive health in adolescent girls based on Cost of response in intervention group before, after and one month after counseling.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150119020719N7
Registration date: 2018-05-09, 1397/02/19
Registration timing: retrospective

Last update: 2018-05-09, 1397/02/19
Update count: 0
Registration date
2018-05-09, 1397/02/19
Registrant information
Name
Sara Esmaelzadeh Saeieh
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
s-esmaelzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of counseling based on protection motivation theory on self care of teenage girls reproductive health
Public title
impact of counseling on teenagers reproductive health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be female Be single The maximum age should be 21 years The first or second year of university
Exclusion criteria:
mental illnesses
Age
From 18 years old to 21 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
4 digit block randomization
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
Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences,Azimieh,,Alborz,Iran
City
Alborz
Province
Alborz
Postal code
0098
Approval date
2018-01-29, 1396/11/09
Ethics committee reference number
Abzums.Rec.1396.164

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
َreproductive health of Adolescents behavior
Timepoint
before intervention,after intervention,one month after intervention
Method of measurement
reproductive health questionnaire of the World Health Organization،Adolescent Reproductive Health Questionnaire which was validated by Alimoradi،The Protection Motivation Theory Questionnaire which validated by faculty members of Alborz midwifery University

Secondary outcomes

1

Description
adolescence sexual behavior
Timepoint
before intervention, after intervention , one month after intervention
Method of measurement
world health organization questionnaire

Intervention groups

1

Description
Intervention group: Receiving six sessions will be held once a week,in each session they have consultation for 90 minutes.The content of the sessions will be as follows: Session 1: definition of reproductive and sexual health, genital anatomy and physiology, counseling about normal and abnormal menstruation, premenstrual syndrome, will include the sharing of information and experiences of girl students in this part. Session 2:The Importance of pregnancy methods and sexual dangers(Understanding the threat and the severity of the vulnerability) Unplanned pregnancy complications at an early age, complications of abortion and bleeding, contraceptive methods, the danger of sexually transmitted diseases. Session 3:( Understanding the internal rewards and external rewards ) sexual cycle, Sexual relationships, sexual health benefits and their impact on the body and mind, safe pregnancy, intended pregnancy, safe sex, self-restraint, loyalty, the benefits of saying no to sexual relationships before marriage from the perspective of students, reasons for doing sexual activity Pre-marriage from the perspective of students and researcher, efficiency improvement of the answer. session 4: Understanding the vulnerability of sexually transmitted diseases, high-risk sexual behavior, its complications, prevention strategies, and the spread of diseases, especially HIV.session 5: Understanding the severity of the risk of high-risk behaviors,sexual rapes,Ways to prevent sexual rape and measures after rape,the ways of protecting against high-risk behaviors (such as smoking and addiction) and their impact on reproductive health.The sixth session :Effectiveness of responses, HIV prevention and counseling ways to reduce the risk of HIV transmission. It includes consultation of negotiation with the sexual partner for using condom and also skill of using condom.understanding self-efficacy, and receiving feedback from prevention methods, self-control skills,skill in control risky behavior and understanding the effectiveness of recommended preventive behavior.The sessions will be validated by the faculty members of the midwifery department at the university.
Category
Lifestyle

2

Description
"Control group":For ethical consideration, after compelete the questionnaires in one month after intervention ,they will receive sexual and reproductive health book.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Alborz university of Medical Sciences
Full name of responsible person
Marjan Havaie
Street address
Alborz University of Medical Sciences,Taleghani avenue,Alborz,Iran
City
Alborz
Province
Alborz
Postal code
0098
Phone
+98 21 5595 6588
Email
marjan.havaie23@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alorz University of Medical Sciences-vice President of Research
Full name of responsible person
Mohammad Noorisepehr
Street address
The research Chonsellor Department of Alborz Medical University,Azimieh Square,Alborz,Iran
City
Alborz
Province
Alborz
Postal code
0098
Phone
+98 26 3255 8920
Email
marjan.havaie23@gmail.com
Grant name
Alorz University of Medical Sciences-vice President of Research
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alorz University of Medical Sciences-vice President of Research
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
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzadeh Saeieh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing Midwifery-Golestan-i-Baghestan-Alborz-Iran
City
Alborz
Province
Alborz
Postal code
0098
Phone
+98 912 623 2569
Email
esmaelzadeh1360@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzade Saieh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
school of Nursing and Midwifery,first Golestan,Baghestan,Alborz,Iran
City
Alborz
Province
Alborz
Postal code
0098
Phone
+98 912 623 2569
Email
esmaelzadeh1360@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzade Saieh
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,first Golestan,Alborz
City
Alborz
Province
Alborz
Postal code
0098
Phone
+98 912 623 2569
Email
esmaelzadeh1360@gmail.com

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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participants data can be shared after being unidentified
When the data will become available and for how long
Start the access period after publishing the results
To whom data/document is available
Public
Under which criteria data/document could be used
For use in studies
From where data/document is obtainable
Marjan havaie Marjane.havaie23@Gmail.com 00989199184356
What processes are involved for a request to access data/document
The application will be sent to the project implementer by email and within 24 hours will receive the necessary items
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