<?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>IRCT20230324057770N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-18</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Digital Etiquette Educational Intervention on Adherence to Virtual Healthy Behaviors in Students</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Effect of Digital Etiquette Educational Intervention on Adherence to Virtual Healthy Behaviors in Primary School Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>245</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70448</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In the present study, one -stage cluster sampling was used. In fact, individuals are not the sampling unit, but schools are the sampling unit. First, the list of all schools with their exact addresses was obtained from the Department of Education, which included 82 schools. Then, based on the resulting list and to homogenize the samples, we categorized them based on the address of each school. Then, all the schools that were more homogenous in terms of socio-economic status and other conditions in the center of Khomeini Shahr were identified, which included 46 schools. In the sampling process, the gender distribution of the participants and their educational level were also considered. Then, considering all the mentioned conditions, using random number table, the following schools were selected as research units, separately from case and control groups:

Selected schools of the intervention group (125 people)
5th grade of Shahid Iraqi Boys' School with 30 students
6th grade of Tarbiyat Boys' School with 24 students
5th grade of Davrpanah 20 Girls' School with 33 students
6th grade of Gol Narges Girls' School with 38 students

Selected schools of the control group (120 people)
5th grade of Besat Boys' School with 30 students
6th grade of Dr. Hassan Ayat Boys' School with 27 students
5th grade of Shahed Amirkhani Girls' School with 30 students
6th grade of Forough girls' school with 33 students.</study_design>
      <phase>N/A</phase>
      <hc_freetext>-.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention will be performed in the following steps: 1. Justification of the selected samples in person regarding the objectives of the study, duration of the study, confidentiality of the participants' information, permission to withdraw from the study while conducting the research, distribution of the written consent form and emphasis to be completed by their parents 2. If the parents do not agree, random selection of another student, distribution of a virtual healthy behavior questionnaire made by the researcher based on the model of prototype and willingness personal information questionnaire and completed by the students of both groups before the educational intervention. 3. Justification of the intervention group regarding the conditions and manner of holding training sessions. 4. The beginning of educational intervention programs for the intervention group on a weekly basis and each session lasts 60-90 minutes.                                                 The duration of the intervention is 6 weeks and is as follows:                       First week: promoting a positive attitude regarding healthy behavior in the cyberspace, holding an educational session by a health education specialist; In the form of questions and answers regarding the definition of digital etiquette and the dimensions of digital citizenship and a discussion about the personal, family and social consequences of not observing etiquette in cyberspace along with solving the exercise (beliefs related to not observing etiquette in cyberspace) and stating statistics relevant in this field, as well as brainstorming and conducting group discussions about responsibility and paying attention to one's own and others' emotions and feelings in the virtual space. Second week: promoting a positive attitude regarding healthy behavior in the virtual space, holding a training session by a health education specialist; In the form of a review of the points presented in the last week, as well as brainstorming and group discussion about successful or unsuccessful experiences regarding the observance of etiquette in cyberspace. Third week: reducing the impact of subjective norms regarding unhealthy behavior in cyberspace, holding a training session by a health education specialist; in the form of group discussions and questions and answers regarding students' reference groups in cyberspace behavior (best friend, parents, teachers, etc.) The exercise solution technique by presenting a scenario related to peer pressure and the behavior of teenagers in cyberspace. Fourth week: promoting positive behavioral ideas of students regarding healthy behavior in cyberspace, holding a training session by a health education specialist; In the form of group discussion and questions and answers regarding the identification of positive and negative mental images of students and the strengthening of positive mental images (regarding teenagers who observe etiquette in cyberspace) and negative (regarding teenagers who observe etiquette in cyberspace) and develop a scenario for teenagers to evaluate a person who performs unhealthy virtual behavior and find that behavior distasteful and reduce their similarity with that person. Fifth week: promoting positive behavioral willingness of students regarding healthy behavior in virtual space, holding a training session by an expert Health Education; In the form of a speech to determine the difference between intentional and unintentional behavior for teenagers, teaching behavioral steps and steps in relation to observing etiquettein cyberspace in high-risk situations, designing a scenario to imagine a high-risk situation and playing a role to change the reaction of students. Sixth week: holding a training session by a health education specialist; In the form of answering questions, repeating topics if needed and getting feedback from students. Intervention 2: Control group: For this group, the following will be done:1- describing the objectives of the study to the participants and obtaining their consent 2- Providing educational content to all members of the control group after completing the study.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Participants' data will remain confidential to the researcher due to the given assurance at the beginning of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Hajihashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 3204</telephone>
        <email>h.hashemimina@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Amidi mazaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 3204</telephone>
        <email>maryamamidi@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fifth and sixth grade boys and girls students wishing to participate in research,
Have a smartphone,
Their parents should be satisfied with their child's participation in the study.</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Students who Have more than 2 sessions absenteeism in training sessions,
Do not be present at the time of collecting data.</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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention will be performed in the following steps: 1. Justification of the selected samples in person regarding the objectives of the study, duration of the study, confidentiality of the participants' information, permission to withdraw from the study while conducting the research, distribution of the written consent form and emphasis to be completed by their parents 2. If the parents do not agree, random selection of another student, distribution of a virtual healthy behavior questionnaire made by the researcher based on the model of prototype and willingness personal information questionnaire and completed by the students of both groups before the educational intervention. 3. Justification of the intervention group regarding the conditions and manner of holding training sessions. 4. The beginning of educational intervention programs for the intervention group on a weekly basis and each session lasts 60-90 minutes.                                                 The duration of the intervention is 6 weeks and is as follows:                       First week: promoting a positive attitude regarding healthy behavior in the cyberspace, holding an educational session by a health education specialist; In the form of questions and answers regarding the definition of digital etiquette and the dimensions of digital citizenship and a discussion about the personal, family and social consequences of not observing etiquette in cyberspace along with solving the exercise (beliefs related to not observing etiquette in cyberspace) and stating statistics relevant in this field, as well as brainstorming and conducting group discussions about responsibility and paying attention to one's own and others' emotions and feelings in the virtual space. Second week: promoting a positive attitude regarding healthy behavior in the virtual space, holding a training session by a health education specialist; In the form of a review of the points presented in the last week, as well as brainstorming and group discussion about successful or unsuccessful experiences regarding the observance of etiquette in cyberspace. Third week: reducing the impact of subjective norms regarding unhealthy behavior in cyberspace, holding a training session by a health education specialist; in the form of group discussions and questions and answers regarding students' reference groups in cyberspace behavior (best friend, parents, teachers, etc.) The exercise solution technique by presenting a scenario related to peer pressure and the behavior of teenagers in cyberspace. Fourth week: promoting positive behavioral ideas of students regarding healthy behavior in cyberspace, holding a training session by a health education specialist; In the form of group discussion and questions and answers regarding the identification of positive and negative mental images of students and the strengthening of positive mental images (regarding teenagers who observe etiquette in cyberspace) and negative (regarding teenagers who observe etiquette in cyberspace) and develop a scenario for teenagers to evaluate a person who performs unhealthy virtual behavior and find that behavior distasteful and reduce their similarity with that person. Fifth week: promoting positive behavioral willingness of students regarding healthy behavior in virtual space, holding a training session by an expert Health Education; In the form of a speech to determine the difference between intentional and unintentional behavior for teenagers, teaching behavioral steps and steps in relation to observing etiquettein cyberspace in high-risk situations, designing a scenario to imagine a high-risk situation and playing a role to change the reaction of students. Sixth week: holding a training session by a health education specialist; In the form of answering questions, repeating topics if needed and getting feedback from students.</i_keyword>
      <i_keyword>Control group: For this group, the following will be done:1- describing the objectives of the study to the participants and obtaining their consent 2- Providing educational content to all members of the control group after completing the study</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attitude towards behavior. Timepoint: 1- Before the intervention 2- Two months after the implementation of the intervention program. Method of measurement: Virtual healthy behavior questionnaire based on prototype and willingness model.</prim_outcome>
      <prim_outcome>Subjective norms. Timepoint: 1- Before the intervention 2- Two months after the implementation of the intervention program. Method of measurement: Virtual healthy behavior questionnaire based on prototype and willingness model.</prim_outcome>
      <prim_outcome>Risk of Prototype. Timepoint: 1- Before the intervention 2- Two months after the implementation of the intervention program. Method of measurement: Virtual healthy behavior questionnaire based on prototype and willingness model.</prim_outcome>
      <prim_outcome>Willingness. Timepoint: 1- Before the intervention 2- Two months after the implementation of the intervention program. Method of measurement: Virtual healthy behavior questionnaire based on prototype and willingness model.</prim_outcome>
      <prim_outcome>Intention to observe netiquette. Timepoint: 1- Before the intervention 2- Two months after the implementation of the intervention program. Method of measurement: Virtual healthy behavior questionnaire based on prototype and willingness model.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Virtual healthy behavior. Timepoint: 1- Before the intervention 2- Two months after the implementation of the intervention program. Method of measurement: Virtual healthy behavior questionnaire based on prototype and willingness model.</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>2023-06-13</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
