<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20150119020719N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-09</date_registration>
      <primary_sponsor>Alorz University of Medical Sciences-vice President of Research</primary_sponsor>
      <public_title>impact of counseling on teenagers reproductive health</public_title>
      <acronym></acronym>
      <scientific_title>The impact of counseling based on protection motivation theory on self care of teenage girls reproductive health</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29347</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 4 digit block randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: "Control group":For ethical consideration, after compelete the questionnaires in one month after intervention ,they will receive sexual and reproductive health book.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All participants data can be shared after being unidentified

When:
Start the access period after publishing the results

To whom:
Public

Conditions:
For use in studies

Where to obtain:
Marjan havaie              
Marjane.havaie23@Gmail.com
00989199184356

How to obtain:
The application will be sent to the project implementer by email and within 24 hours will receive the necessary items

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Esmaelzadeh Saeieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing Midwifery-Golestan-i-Baghestan-Alborz-Iran</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098</zip>
        <telephone>+98 912 623 2569</telephone>
        <email>esmaelzadeh1360@gmail.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Esmaelzade Saieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>school of Nursing and Midwifery,first Golestan,Baghestan,Alborz,Iran</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098</zip>
        <telephone>+98 912 623 2569</telephone>
        <email>esmaelzadeh1360@gmail.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be female
Be single
The maximum age should be 21 years
The first or second year of university</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>21 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>mental illnesses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>"Control group":For ethical consideration, after compelete the questionnaires in one month after intervention ,they will receive sexual and reproductive health book.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>َ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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adolescence sexual behavior. Timepoint: before intervention, after intervention , one month after intervention. Method of measurement: world health organization questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Alorz University of Medical Sciences-vice President of Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-29</approval_date>
        <contact_name>Alborz University of Medical Sciences</contact_name>
        <contact_address>Alborz University of Medical Sciences,Azimieh,,Alborz,Iran Alborz Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
