<?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>IRCT20200907048651N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-03</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education on raising mothers' awareness of accidents in children</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Multimedia Educational Intervention on Prevention of Home Accidents in Mothers with Children Under Five Years: An Application of Protection Motivation Theory</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50861</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling will be done in two stages so that initially 4 centers (2 centers for training and 2 centers as a control group) will be selected from 10 comprehensive health service centers in Bushehr by simple random method. Then, in each center, in proportion to the number of women with children under 5 years old, covered by that center and based on the calculated sample size, the number of samples is selected. Then, the electronic file of mothers in the integrated health system (Apple) is evaluated to check the inclusion criteria and among the mothers with the initial inclusion criteria, the desired number (equal to the sample size) is randomly selected by lot and then contacted. Will be taken to get information about other criteria for entering the study (having a computer, tablet or smart phone, Internet access) and having the consent to participate in the study. According to the number of selected mothers who did not meet the conditions for entering the study or willingness to participate in the study, the rest of the list is randomly selected and sampling continues until the sample size is reached.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Accidents.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: educational intervention for the intervention group is designed and presented in ten days through multimedia including motion graphics, video with motion graphics plugins, podcasts and illustrated text attachments on the website, and then sending a reminder message for up to two months as a reminder. Intervention 2: Control group: They only receive routine training.</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 I have not made a decision yet, there is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Seyed Hamamuddin Javadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr University of Medical Sciences; Salman Farsi street</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 913 021 6071</telephone>
        <email>homamjavadzade@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyed Homamuddin Javadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr University of Medical Sciences; Salman Farsi street</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 913 021 6071</telephone>
        <email>homamjavadzade@gmail.com</email>
        <affiliation>Boushehr 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>
    </countries>
    <criteria>
      <inclusion_criteria>Having an electronic health record in the integrated health system (Sib)
Having a child under 5 years old
Have a computer, tablet or smart phone and get acquainted with working with it
Internet access
Literacy for reading and writing
Willingness to participate in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>51 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The child has incurable disease
The mother has physical or mental health problems that affect her caring role
The child is cared for full time by a person other than the mother.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S00-T98</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury, poisoning and certain other consequences of external causes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: educational intervention for the intervention group is designed and presented in ten days through multimedia including motion graphics, video with motion graphics plugins, podcasts and illustrated text attachments on the website, and then sending a reminder message for up to two months as a reminder.</i_keyword>
      <i_keyword>Control group: They only receive routine training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Preventive behaviors of home accidents. Timepoint: Before training and two months after training. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Awareness. Timepoint: Before training and two months after training. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Perceived sensitivity. Timepoint: Before training and two months after training. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Perceived severity. Timepoint: Before training and two months after training. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Perceived self-efficacy. Timepoint: Before training and two months after training. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Perceived costs. Timepoint: Before training and two months after training. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Perceived reward. Timepoint: Before training and two months after training. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Perceived response efficiency. Timepoint: Before training and two months after training. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Fear. Timepoint: Before training and two months after training. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Protective motivation. Timepoint: Before training and two months after training. 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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-14</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>Bushehr University of Medical Sciences; Salman Farsi street Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
