<?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>IRCT20210623051681N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-26</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the impact of educational messages based on an Extended ‎Parallel ‎Process Model on preventive behaviors of the infectious respiratory ‎diseases, with emphasis on COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the impact of educational messages based on an Extended ‎Parallel ‎Process Model on preventive behaviors of the infectious respiratory ‎diseases, with emphasis on COVID-19 among elementary school girls: A ‎four-group randomized trial‏‏‏</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57161</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: First, a list of names of all girls' schools in Borkhar city, including the number of fifth grade elementary students, is prepared and given to each of the schools. The city will be given a two-digit code (01,02, 03, ..., 38). Then we select 16 codes randomly using a simple random number table, then again sampled using a random number table of 16 schools, into different study groups (three intervention groups and one control group) Will be allocated, Blinding description: The data analyzer is not aware of the allocation of individuals in study groups (intervention and control) which was done randomly. This random method has led to a one-way blinding of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infectious Respiratory Diseases, with emphasis on Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: The first group of intervention: by referring to the schools in question and talking to the principal of each school, they are asked to cooperate, then the parents of the children are called and the plan is explained to them and if they want to cooperate, they are asked to use Their contact number in WhatsApp or Shad should form a group and be divided into 4 study groups according to the randomly selected samples and, if necessary, attend the school in accordance with the health protocols. This study will be invited to participate in the study. Research subjects will be justified on how to do it, the confidentiality of information and also the purpose of the study, and all of them will enter the study if they wish and after expressing their consent. Before conducting the educational intervention in order to perform (Pre-test), the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Online questionnaires will be completed within 7 days. Educational posters will be selected from educational posters approved by the Ministry of Health and will be divided into three test groups based on the content of the poster. Will be sent with the intervention group. In the first intervention group: after the pre-test, 3 posters containing messages of perceived severity and sensitivity (perceived threat) based on EPPM and related to the topic of preventive behaviors Quid will be sent. After the educational intervention for post-test, the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Intervention 2: The second group of intervention: by referring to the schools in question and talking to the principal of each school, they are asked to cooperate, then the parents of the children are contacted by phone and the plan is explained to them and asked if they want to cooperate using Their contact number should be grouped in WhatsApp or Shad and should be divided into 4 study groups according to the randomly selected samples and, if necessary, attend the school in accordance with health protocols. Students should be selected based on the inclusion criteria and qualified This study will be invited to participate in the study. Research subjects will be justified on how to do it, the confidentiality of information and also the purpose of the study, and all of them will enter the study if they wish and after expressing their consent. Before performing the educational intervention in order to perform (Pre-test), the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Online questionnaires will be completed within 7 days. Educational posters will be selected from educational posters approved by the Ministry of Health and based on the content of the poster will be divided into three test groups and during the intervention (one week) three appropriate posters for each test group. Will be sent with the intervention group. In the second group of the intervention: After the pre-test, 3 posters will be sent containing the perceived efficiency messages based on EPPM and related to the topic of Covid prevention behaviors. After the educational intervention for post-test, the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Intervention 3: Intervention group 3: By referring to the schools in question and talking to the principal of each school, they are asked to cooperate, then the parents of the children are contacted by phone and the plan is explained to them and asked if they want to cooperate using Their contact number in WhatsApp or Shad should form a group and be selected in 4 groups according to the randomly selected samples and, if necessary, attend the school in accordance with health protocols. Students are selected based on the inclusion criteria and are eligible. This study will be invited to participate in the study. Research subjects will be justified on how to do it, the confidentiality of information and also the purpose of the study, and all of them will enter the study if they wish and after expressing their consent. Before conducting the educational intervention in order to perform (Pre-test), the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Online questionnaires will be completed within 7 days. Educational posters will be selected from educational posters approved by the Ministry of Health and will be divided into three test groups based on the content of the poster. Will be sent with the intervention group. In the third intervention group: After the pre-test, 3 posters containing threatening messages and perceived effectiveness based on EPPM and related to the topic of prevention behaviors will be sent. After the educational intervention for post-test, the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Intervention 4: Fourth intervention group (control): by referring to the schools in question and talking to the principal of each school, they are asked to cooperate, then the children's parents are called and the plan is explained to them and they are asked if they want to cooperate. Using their WhatsApp or Shad contact number, form a group and study in 4 groups according to the randomly selected samples and, if necessary, attend the school in accordance with health protocols. Students are selected based on the inclusion criteria and Eligible students of this study will be invited to participate in the study. Research subjects will be justified on how to do it, the confidentiality of information and also the purpose of the study, and all of them will enter the study if they wish and after expressing their consent. Before conducting the educational intervention in order to perform (Pre-test), the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Online questionnaires will be completed within 7 days. Educational posters will be selected from educational posters approved by the Ministry of Health and will be divided into three test groups based on the content of the poster. Will be sent with the intervention group. In the fourth group of intervention: the group that is considered as the control group will not be subjected to any educational intervention and one week after the intervention, simultaneously with the first, second and third groups of the post-test in this The group will do the same.</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>Soheila SHarifi habibabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No18, Haft Tir Ave., SHahid Motahari street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>‎8346138731‎</zip>
        <telephone>+98 31 4548 2051</telephone>
        <email>ssharifi514@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fereshteh Zamani Alavijeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 3292</telephone>
        <email>fe.zamani@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fifth grade elementary school girls living in Borkhar city
Having the consent to participate in the study
Having a smartphone and attending a virtual application (SHad or Whats App)</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Student's unwillingness to continue participating in the study
Leaving the city for any reason
Failure to complete the questionnaire in the pre-test or post-test
Loss of access to messages and questionnaires for any reason related to the smartphone and leaving the virtual application (SHad or Whats App)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first group of intervention: by referring to the schools in question and talking to the principal of each school, they are asked to cooperate, then the parents of the children are called and the plan is explained to them and if they want to cooperate, they are asked to use Their contact number in WhatsApp or Shad should form a group and be divided into 4 study groups according to the randomly selected samples and, if necessary, attend the school in accordance with the health protocols. This study will be invited to participate in the study. Research subjects will be justified on how to do it, the confidentiality of information and also the purpose of the study, and all of them will enter the study if they wish and after expressing their consent. Before conducting the educational intervention in order to perform (Pre-test), the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Online questionnaires will be completed within 7 days. Educational posters will be selected from educational posters approved by the Ministry of Health and will be divided into three test groups based on the content of the poster. Will be sent with the intervention group. In the first intervention group: after the pre-test, 3 posters containing messages of perceived severity and sensitivity (perceived threat) based on EPPM and related to the topic of preventive behaviors Quid will be sent. After the educational intervention for post-test, the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully.</i_keyword>
      <i_keyword>The second group of intervention: by referring to the schools in question and talking to the principal of each school, they are asked to cooperate, then the parents of the children are contacted by phone and the plan is explained to them and asked if they want to cooperate using Their contact number should be grouped in WhatsApp or Shad and should be divided into 4 study groups according to the randomly selected samples and, if necessary, attend the school in accordance with health protocols. Students should be selected based on the inclusion criteria and qualified This study will be invited to participate in the study. Research subjects will be justified on how to do it, the confidentiality of information and also the purpose of the study, and all of them will enter the study if they wish and after expressing their consent. Before performing the educational intervention in order to perform (Pre-test), the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Online questionnaires will be completed within 7 days. Educational posters will be selected from educational posters approved by the Ministry of Health and based on the content of the poster will be divided into three test groups and during the intervention (one week) three appropriate posters for each test group. Will be sent with the intervention group. In the second group of the intervention: After the pre-test, 3 posters will be sent containing the perceived efficiency messages based on EPPM and related to the topic of Covid prevention behaviors. After the educational intervention for post-test, the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully.</i_keyword>
      <i_keyword>Intervention group 3: By referring to the schools in question and talking to the principal of each school, they are asked to cooperate, then the parents of the children are contacted by phone and the plan is explained to them and asked if they want to cooperate using Their contact number in WhatsApp or Shad should form a group and be selected in 4 groups according to the randomly selected samples and, if necessary, attend the school in accordance with health protocols. Students are selected based on the inclusion criteria and are eligible. This study will be invited to participate in the study. Research subjects will be justified on how to do it, the confidentiality of information and also the purpose of the study, and all of them will enter the study if they wish and after expressing their consent. Before conducting the educational intervention in order to perform (Pre-test), the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Online questionnaires will be completed within 7 days. Educational posters will be selected from educational posters approved by the Ministry of Health and will be divided into three test groups based on the content of the poster. Will be sent with the intervention group. In the third intervention group: After the pre-test, 3 posters containing threatening messages and perceived effectiveness based on EPPM and related to the topic of prevention behaviors will be sent. After the educational intervention for post-test, the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully.</i_keyword>
      <i_keyword>Fourth intervention group (control): by referring to the schools in question and talking to the principal of each school, they are asked to cooperate, then the children's parents are called and the plan is explained to them and they are asked if they want to cooperate. Using their WhatsApp or Shad contact number, form a group and study in 4 groups according to the randomly selected samples and, if necessary, attend the school in accordance with health protocols. Students are selected based on the inclusion criteria and Eligible students of this study will be invited to participate in the study. Research subjects will be justified on how to do it, the confidentiality of information and also the purpose of the study, and all of them will enter the study if they wish and after expressing their consent. Before conducting the educational intervention in order to perform (Pre-test), the link of the online questionnaire will be placed among the selected students of the test and control groups, then they will be asked to answer the questionnaire carefully. Online questionnaires will be completed within 7 days. Educational posters will be selected from educational posters approved by the Ministry of Health and will be divided into three test groups based on the content of the poster. Will be sent with the intervention group. In the fourth group of intervention: the group that is considered as the control group will not be subjected to any educational intervention and one week after the intervention, simultaneously with the first, second and third groups of the post-test in this The group will do the same.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory Infectious Diseases Prevention Behaviors, with Emphasis on Covid-19. Timepoint: One week after the intervention. Method of measurement: A  researcher-made 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-09</approval_date>
        <contact_name>Ethics committee of isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
