<?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>IRCT20210612051555N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-30</date_registration>
      <primary_sponsor>Damanhour University- Faculty of Nursing</primary_sponsor>
      <public_title>Effect of Interactive Digital-based Psychoeducational Intervention about COVID-19 on Knowledge, Fear, and Anxiety among Secondary School Students</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Interactive Digital-based Psychoeducational Intervention about COVID-19 on Knowledge, Fear, and Anxiety among Secondary School Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59209</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Corona virus related anxiety and fear.</hc_freetext>
      <i_freetext>Intervention group: The intervention will be conducted according to the following phases: I. Needs assessment Phase: The study instrument will be entered to the Google form spreadsheet. A WhatsApp group will be created to share the link with the students for the pre-post-test. A pre-test will be completed to evaluate the students’ knowledge about COVID-19 and the associated level of fear and anxiety to address insufficiencies to be deemed during the construction of the psychoeducational intervention. It is also will be used as baseline data for comparison with the post-test. II. Planning phase: interactive digital-based psychoeducational intervention about COVID-19 will be developed by the researchers according to the following steps: -a. Setting objectives• General objective: Improve the students ‘knowledge about COVID-19 and alleviate fear and anxiety from COVID-19: •Specific objectives: -Identify the COVID-19 pandemic-List the possible signs and symptoms of COVID-19-	Discuss the preventive measures against Coronavirus infection-Explain the main complications of COVID-19 and its treatment-	Conceptualize the COVID-19 related fear and anxiety and their causes-	Mention symptoms linked to fear and anxiety and their alleviating measures -Demonstrate different relaxation techniques-Apply different ways to reduce fear and anxiety of COVID-19 b. Preparation of the content and presentation methods: The content will be designed by the researchers to cover all the predetermined objectives. It will be developed based on a review of relevant recent literature about COVID-19. It will contain information about the COVID-19 definition, possible signs and symptoms, modes of transmission, preventive behaviors and vaccination, complications, and treatment. In addition to the definition of COVID-19 related fear and anxiety, possible signs, and symptoms, causes, and different relaxation techniques and alleviating measures.-	Numerous interactive digital-based methods will be developed to present the content as a WhatsApp group, enlisting the students’ Emails, and Zoom meetings. In addition to, PowerPoint presentation, animated graphics, and educational videos- Implementation Phase:-The fieldwork will be spanned for six consecutive months starting from November 2021to May 2022. The total sample will be divided into six subgroups (30-35) where four sessions on Zoom (about 35-40 minutes) will be conducted for every subgroup with a total of 24 sessions for the whole sample. The WhatsApp group will be employed for fostering daily communication with the students either in written format or using audio messages. Emails will be used for delivering the PowerPoint, educational videos, and graphics. IV- Evaluation Phase. The posttest will be conducted after three months from implementing the intervention, with the aim of comparing the results with the baseline data from the pretest to assure the fulfillment of the study aim..</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:
Published research report that contains all the findings of the study.

When:
within one year and will be available long life

To whom:
for public

Conditions:
for scientific use and public education

Where to obtain:
None

How to obtain:
none

Comments:
none</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samiha Hamdi Sayed Ramadan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damanhour, Elbehira, Governorate, Egypt</address>
        <city>Damahour</city>
        <country1>Egypt</country1>
        <zip>22511</zip>
        <telephone>+20 45 3311679</telephone>
        <email>samihareda93@gmail.com</email>
        <affiliation>Damanhour University- Faculty of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samiha Hamdi Sayed Ramadan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damanhour, Elbehira, Governorate, Egypt</address>
        <city>Damahour</city>
        <country1>Egypt</country1>
        <zip>22511</zip>
        <telephone>+20 45 3311679</telephone>
        <email>samihareda93@gmail.com</email>
        <affiliation>Damanhour University- Faculty of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Egypt</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both sexes
Possessed a smart mobile phone/computer and internet connection
Willing to participate in the study</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>19 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Visual or auditory problems
Psychological or mental disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention will be conducted according to the following phases: I. Needs assessment Phase: The study instrument will be entered to the Google form spreadsheet. A WhatsApp group will be created to share the link with the students for the pre-post-test. A pre-test will be completed to evaluate the students’ knowledge about COVID-19 and the associated level of fear and anxiety to address insufficiencies to be deemed during the construction of the psychoeducational intervention. It is also will be used as baseline data for comparison with the post-test. II. Planning phase: interactive digital-based psychoeducational intervention about COVID-19 will be developed by the researchers according to the following steps: -a. Setting objectives• General objective: Improve the students ‘knowledge about COVID-19 and alleviate fear and anxiety from COVID-19: •Specific objectives: -Identify the COVID-19 pandemic-List the possible signs and symptoms of COVID-19-	Discuss the preventive measures against Coronavirus infection-Explain the main complications of COVID-19 and its treatment-	Conceptualize the COVID-19 related fear and anxiety and their causes-	Mention symptoms linked to fear and anxiety and their alleviating measures -Demonstrate different relaxation techniques-Apply different ways to reduce fear and anxiety of COVID-19 b. Preparation of the content and presentation methods: The content will be designed by the researchers to cover all the predetermined objectives. It will be developed based on a review of relevant recent literature about COVID-19. It will contain information about the COVID-19 definition, possible signs and symptoms, modes of transmission, preventive behaviors and vaccination, complications, and treatment. In addition to the definition of COVID-19 related fear and anxiety, possible signs, and symptoms, causes, and different relaxation techniques and alleviating measures.-	Numerous interactive digital-based methods will be developed to present the content as a WhatsApp group, enlisting the students’ Emails, and Zoom meetings. In addition to, PowerPoint presentation, animated graphics, and educational videos- Implementation Phase:-The fieldwork will be spanned for six consecutive months starting from November 2021to May 2022. The total sample will be divided into six subgroups (30-35) where four sessions on Zoom (about 35-40 minutes) will be conducted for every subgroup with a total of 24 sessions for the whole sample. The WhatsApp group will be employed for fostering daily communication with the students either in written format or using audio messages. Emails will be used for delivering the PowerPoint, educational videos, and graphics. IV- Evaluation Phase. The posttest will be conducted after three months from implementing the intervention, with the aim of comparing the results with the baseline data from the pretest to assure the fulfillment of the study aim.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>COVID-19 knowledge. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Self-report knowledge questionnaire.</prim_outcome>
      <prim_outcome>COVID-19 related fear. Timepoint: Before intervention and 2 months after intervention. Method of measurement: COVID-19 fear scale (adopted from Ahorsu et. Al, 2020).</prim_outcome>
      <prim_outcome>COVID-19 related anxiety. Timepoint: Before intervention and 2 months after intervention. Method of measurement: COVID-19 anxiety scale - A screening tool for dysfunctional anxiety associated with the coronavirus crisis (Lee 2020).</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>Damanhour University- Faculty of Nursing</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-19</approval_date>
        <contact_name>Ethic's committee of the Faculty of Nursing- Damanhour University</contact_name>
        <contact_address>Damanhour, Elbehira, Governorate, Egypt Damahour Elbehira Governorate Egypt</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
