<?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>IRCT20170520034052N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-15</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Mobile App-based education on reproductive health awareness and self-care behaviors i</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Mobile App-based education on reproductive health awareness and self-care behaviors in married students: a Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>164</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40659</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Tabriz University and Tabriz University of Medical Sciences each have 4 government dormitories that sampling will be placed at every 8 dormitories. In order to avoid contamination, 4 dormitories will be allocated into the intervention and 4 dormitories into the control group by non-researcher person (random allocation). Considering the fact that knowledge and self-care is likely to be higher among married students of the medical university, stratification will be done in terms of type of dormitory. For stratification, the first 4 envelopes will be dedicated to Tabriz medical university and 4 next envelopes to Tabriz University. In this condition, for each intervention dormitory, there will be a control group at the same university. Then, in order to allocation concealment, the name of dormitories will be written on the matte and closed envelopes based on the random allocation sequence, and the type of intervention will be placed in a  paper inside envelope by the same person. In the next step, 20-22 eligible married students from each dormitory will be included in the study through availability sampling. The researcher and the participants will not be informed about the allocation type until the stage of opening the envelopes (after completing the questionnaires).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Knowledge regarding reproductive health. Condition 2: Self-care behaviors regarding reproductive health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The counseling program for the intervention group will be presented in two sessions for 45-60 minutes, in  the 12 people' groups once a week. Invitational counseling in this intervention will be based on  William w.Purkey. During counseling sessions, combined methods such as; face-to-face training, question and answer, and group discussion, will also be used. At the end of the session, the reproductive health education software program will be installed on the mobile phone of the intervention group and will be studied by the participants within the next four weeks. Intervention 2: Control group: There will be no action for the control group at the time of the intervention. If the training be effective for the intervention group, after the completion of the study, educational materials for reproductive health will be provided to the control group in the form of a 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:
Requested information will be provided to researchers for statistical analysis of the submitted proposal.

When:
Start the access period immediately after printing the results

To whom:
Data will be available to researchers as well as to journals

Conditions:
Data will be available to researchers upon request and submission of a proposal to perform a meta-analysis using ipd data after unidentifiable individuals. Also, exceptionally, data will be exclusively for checking the data available to journals.

Where to obtain:
En Refer to email address.(aa.karimi.v@gmail.com)

How to obtain:
Requests will be sent by email and the data will be available within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Karimi Vanestanagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sciences, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5471895481</zip>
        <telephone>+98 41 4322 4562</telephone>
        <email>aa.karimi.v@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Karimi Vanestanagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>End of Dr. Shariati, Faculty of Nursing and Midwifery</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5471895481</zip>
        <telephone>+98 41 4322 4562</telephone>
        <email>aa.karimi.v@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being married
Student studying at Tabriz University of Medical Sciences or Tabriz University
Having a smartphone
Ability to use WhatsApp and mobile software.
Female sex</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>End of education (graduation, dispensing, expulsion, ...) and end of the course for guest students at the time of this study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z71</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Persons encountering health services for other counseling and medical advice, not elsewhere classified</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The counseling program for the intervention group will be presented in two sessions for 45-60 minutes, in  the 12 people' groups once a week. Invitational counseling in this intervention will be based on  William w.Purkey. During counseling sessions, combined methods such as; face-to-face training, question and answer, and group discussion, will also be used. At the end of the session, the reproductive health education software program will be installed on the mobile phone of the intervention group and will be studied by the participants within the next four weeks.</i_keyword>
      <i_keyword>Control group: There will be no action for the control group at the time of the intervention. If the training be effective for the intervention group, after the completion of the study, educational materials for reproductive health will be provided to the control group in the form of a book.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of knowledge on reproductive health. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: Researcher- made knowledge questionnaire.</prim_outcome>
      <prim_outcome>Score of self-care behavior on reproductive health. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: Researcher-made self-care questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in students awareness' score on reproductive health 8 weeks after the intervention compared to pre-intervention in each study group. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Awareness Questionnaire.</sec_outcome>
      <sec_outcome>Change in students self-care behaviors' score on reproductive health 8 weeks after the intervention compared to pre-intervention in each of the study groups. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Self-care 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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-17</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
