<?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>IRCT20190119042407N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-05</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mobile-based education on anxiety and physiological indices of candidates for coronary artery angiography</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mobile-based education on anxiety and physiological indices of candidates for coronary artery angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36958</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The method of assigning the intervention was randomized and random blocked blocks with block size 4.</study_design>
      <phase>3</phase>
      <hc_freetext>A Study of Mobile Based Learning Strategy on Reducing Anxiety in Candidate Patients for Coronary Angiography.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, educational content is presented using mobile software. To this end, the educational materials including familiarity of the patient with the process of angiography and its adaptation, its complications, familiarity with the angiography, anxiety control methods based on psychological references in a face-to-face meeting were developed as a program and Certification supervisors are displayed to the patient as software on a mobile phone and expressed by the researcher on how to use it. Intervention 2: Control group: The patient will receive the educational content routinely in the Angiography ward.</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'm still in the sampling stage.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Zafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 325, Mostafa Khomeini Ave</address>
        <city>Andimeshk</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6481749786</zip>
        <telephone>+98 61 4263 3716</telephone>
        <email>eh.zafari@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dariush Rokhafroz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Jundishapur University of Ahvaz</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61337338070</telephone>
        <email>darushrokhafroz@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients undergoing coronary artery angiography
For the first time candidate for angiography</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who do not have access to smart phones
Patients who do not read and write</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, educational content is presented using mobile software. To this end, the educational materials including familiarity of the patient with the process of angiography and its adaptation, its complications, familiarity with the angiography, anxiety control methods based on psychological references in a face-to-face meeting were developed as a program and Certification supervisors are displayed to the patient as software on a mobile phone and expressed by the researcher on how to use it.</i_keyword>
      <i_keyword>Control group: The patient will receive the educational content routinely in the Angiography ward</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The open and hidden anxiety variables are made up of 40 questions by the Spielberger questionnaire. This questionnaire is used to measure the amount of anxiety. The first 20 questions were the anxiety state (apparent anxiety) and 20 questions of the anxiety tract (hidden anxiety). puts. In answering subjects to anxiety, there are a number of options for each statement, which they should select the option that best expresses their emotion. These options are: 1. Altogether 2. Altogether 3. Medium 4. Altogether. Options to respond to the anxiety tract scale include: 1. Almost never 2. Sometimes 3. Often 4. Almost always. In order to obtain an individual's anxiety score in each of the two scales, the total score of all twenty words of each scale is computed with respect to the fact that some of the phrases are translated verbatim and some of the terms are scored in reverse order. Therefore, the scores of each of the two state scales and the anxiety trap can range from 20 to 80. Scoring weights are inverse for non-anxiety expressions. The terms that are scored in reverse order when scoring, that is, in these questions the answer of a score of 3, the response of the two scores 2, and the response of a score of 1, are: the scale of the anxiety state: 20, 19, 16, 15, 11, 10, 8, 5, 2, 1 Anxiety Tract Scale: 39, 36, 34, 33, 30, 27, 26, 23, 21 The rest of the questions are scored directly, so that the answers to these questions A score of 1, a double response, and a three-point response score of 3. According to the scale of the case, scores 20-30 represent no apparent anxiety, scores 42-31 indicate a clear, mild anxiety, scores 53-43 represent moderate anxiety and scores of 54 and more indicate severe anxiety. According to the vein scale, scores of 34-20 did not indicate or the lowest amount of hidden anxiety, scores of 45-35 representing mild anxiety, scores 56-46 representing moderate anxiety and scores of 57 and more indicate severe anxiety, this factor is mild, moderate Or the severity of the level of apparent and hidden anxiety is measured. Timepoint: The first turn is when the patient is angiographed by the candidate. A second shift takes place half an hour after entering the department and performing routine routine pre-angiography at rest in the bed. The third appointment is immediately investigated as soon as the patient is called to perform angiography. Further, the data will be taken through the statistical analysis methods described in the next section and will be carefully evaluated. Method of measurement: Spielberger Questionnaire, Physiological Indicator Questionnaire, Rossmax Manometer Device Made in Taiwan, CE Certificate.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>بهبود نمره پرسشنامه اسپیلبرگر، کاهش اضطراب، شاخص های فیزیولوژیکدر محدوده نرمال. Timepoint: The first turn is when the patient is angiographed by the candidate. A second shift takes place half an hour after entering the department and performing routine routine pre-angiography at rest in the bed. The third appointment is immediately investigated as soon as the patient is called to perform angiography. Further, the data will be taken through the statistical analysis methods described in the next section and will be carefully evaluated. Method of measurement: Spielberger Questionnaire, Physiological Indicator Questionnaire, Rossmax Manometer Device Made in Taiwan, CE Certificate.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-05</approval_date>
        <contact_name>Ethics committee of Ahwaz Jundishapor University of Medical Sciences</contact_name>
        <contact_address>Academic City, Adjacent to Central Office of Jundishapur University of Medical Sciences and Health Services, Ahwaz, Deputy of Research and Technology Development.َ Ahwaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
