<?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>IRCT20200924048825N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-08</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education Mobile application on the preventive behaviors of harmful effects of sunshine</public_title>
      <acronym></acronym>
      <scientific_title>design and evaluation of a Mobile application based on the protection motivation theory on the preventive behaviors of harmful effects of sunshine in girl and boy students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>320</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52097</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: Limited randomization because we want the sample size to be equal in both intervention and control groups, so we will choose this limited randomization as a block randomization with 5 blocks and in each block one school in the intervention group and one school in the group Control is placed.
Randomization unit: Multi-stage cluster
Randomization tool: statistical software
Random allocation concealment: using opaque envelopes sealed with random sequence In this way, based on the volume of the research sample, a number of envelopes with aluminum wrappers (in order not to clarify the contents of the envelopes) are prepared and each of the random assignments created is recorded on a card And the cards are placed in the mail envelopes in order .
In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside the boxes, respectively.

At the beginning of the registration of participants, based on the order of entry of eligible participants to study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>skin cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention in the school under evaluation, which includes a educational session of approximately 25 to 30 minutes, including the installation and download time of 45 minutes, will be performed in the virtual classroom environment of Shad software using a photography application. For the first 10 minutes, the student takes a three-dimensional selfie, then offers two categories of classification. . In 15 to 20 minutes, the student interacts with the remaining functions of the program, including facial changes, ABCDE rules, and sun protection instructions. In the last 5 to 10 minutes. After the intervention, the participants are sent instructions to remove the application from their phone and immediately after the intervention, students are asked to assess the understanding of the intervention immediately after the intervention. Complete (postest) and send to the executor. Again, 3 and 6 months after the intervention, an invitation will be sent to the students' knowledge, who will be asked to receive a post-test questionnaire and send it to the project manager after completion. Intervention 2: Control group: There is no intervention and at the end of the work, educational materials will be provided to them.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>esmat sadat hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>bolvare saralah 7</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817765377</zip>
        <telephone>+98 54 3344 0098</telephone>
        <email>hosini.esmat@gmail .com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>esmat sadat hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>bolvare saralah 7</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817765377</zip>
        <telephone>+98 54 3344 0098</telephone>
        <email>e.hosseini@stu.ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female students in the fourth to sixth grades of elementary school in Zahedan in the  year 1399-1400</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance and satisfaction to participate in the study
Absence of students</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>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention in the school under evaluation, which includes a educational session of approximately 25 to 30 minutes, including the installation and download time of 45 minutes, will be performed in the virtual classroom environment of Shad software using a photography application. For the first 10 minutes, the student takes a three-dimensional selfie, then offers two categories of classification. . In 15 to 20 minutes, the student interacts with the remaining functions of the program, including facial changes, ABCDE rules, and sun protection instructions. In the last 5 to 10 minutes. After the intervention, the participants are sent instructions to remove the application from their phone and immediately after the intervention, students are asked to assess the understanding of the intervention immediately after the intervention. Complete (postest) and send to the executor. Again, 3 and 6 months after the intervention, an invitation will be sent to the students' knowledge, who will be asked to receive a post-test questionnaire and send it to the project manager after completion.</i_keyword>
      <i_keyword>Control group: There is no intervention and at the end of the work, educational materials will be provided to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge and behavior and  structures of protection motivation. Timepoint: pretest and postest. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-21</approval_date>
        <contact_name>دانشگاه علوم پزشکی  شهید صدوقی یزد</contact_name>
        <contact_address>Sarollah Boulevard 7 zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
