<?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>IRCT2017080335479N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-04</date_registration>
      <primary_sponsor>Vice chancellor for research and Technology, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of multimedia education on anxiety and physiological indexes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of multimedia education on anxiety and physiological indexes in patients candidate for cerebrovascular angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26794</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>2-3</phase>
      <hc_freetext>cerebrovascular angiography.</hc_freetext>
      <i_freetext>Intervention 1: The intervention of this study will be multimedia education. Multimedia education in this study will consist of movie (video), educational pamphlet (booklet), oral education and answers to questions posed by patients. The following is an explanation of each component of multimedia learning. (A) Educational movie (video): The content of the video includes information on the pre-angiography readiness, the conditions and equipment needed in the angiographic room, the way angiography is performed, the care required after angiography. Also, the things that need to be considered after taking out hospital care are provided in this video tutorial. This video will be made using Adobe Premiere. The film begins providing information about the preparation for angiography and will end with the necessary care after discharge from the hospital and at home. The film will use images and animations related to angiography and will be called by one of the researchers. The contents of the educational and video materials will be based on the resources and standards related to the cerebrovascular angiography, and after the approval of the professors of the faculty of internal medicine and the neuroscience department will be used for training. B) Educational pamphlet (booklet): In the educational pamphlet, the content of the movie displayed to patients will be summarized in a written and color-coded form with pictures for patients. This booklet will be available to patients for reading. C) verbal education: verbal education will provide patients with information on cerebrovascular angiography, how to do it and its related care as a lecture and verbal to the candidate for cerebrovascular angiography. D) Answering patient questions: At the end, patients are requested to ask questions if they need additional information, as well as express their concerns. Their questions will be answered and the relevant information will be provided to them. Intervention in the intensive care unit will be performed on the cerebral  angiography in Firoozgar Hospital. After admission to this section, patients will be prepared for brain angiography. Intervention at the time of hospitalization in patients and at least 30 minutes in a room designed to patients education. Since cerebrospinal angiography is performed in the morning and afternoon shifts and on non-holiday days, interventions will take place in the morning and evening shifts of non-holiday days. Intervention 2: The control group will not receive any educational intervention. This group will receive only the routine method in the department. Routine measures include: a) informed consent of patients about performing angiography; b) cleaning the skin; insertion of the catheter; c) taking the peripheral vessel; d) administering the drug in accordance with the relevant physician's orders; c) monitoring the vital signs every two hours before and after cerebral angiography.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Ahmadkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirkhani St (East Nosrat), Tohid Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4325</telephone>
        <email>ahmadkhani.nrsz@gmail.com</email>
        <affiliation>School of Nursing &amp; Midwifery, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Sayadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirkhani St (East Nosrat), Tohid Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4322</telephone>
        <email>l-sayadi@sina.tums.ac</email>
        <affiliation>School of Nursing &amp; Midwifery, Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients participating in the study will have the following characteristics: • For the first time candidates for vascular catheterization, • At least 16 years of age, • Speak in Persian. • Ability to read and write and able to complete the questionnaire; • Satisfy the study; • During cerebral angiography; they have not received sedative medications; • They are not part of the hospital staff and are not familiar with cerebrovascular angiography; • Emergency needs; Do not have a catheterization of the cerebrospinal• Have no previous history of brain or cardiac catheterization; • Have no cognitive impairment; • Do not receive drugs for psychiatric disorders / benzodiazepines or anxiolytic drugs; • Steroids and substances Drugs do not consume; • Do not have blindness and severe hearing / hearing impairment; • Do not have chronic or life-threatening illnesses (such as cancer); •Do not require admission to specialized care because of their conditions; • Pre-admission patients have special training in no association with cerebral angiography • There are no hormonal disorders associated with thyroid, adrenal gland, and pituitary. &#13;
Exclusion criteria: Do not wish to continue research. The patient dies during or after angiography. The patient has a loss of consciousness.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vascular syndromes of brain in cerebrovascular diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention of this study will be multimedia education. Multimedia education in this study will consist of movie (video), educational pamphlet (booklet), oral education and answers to questions posed by patients. The following is an explanation of each component of multimedia learning. (A) Educational movie (video): The content of the video includes information on the pre-angiography readiness, the conditions and equipment needed in the angiographic room, the way angiography is performed, the care required after angiography. Also, the things that need to be considered after taking out hospital care are provided in this video tutorial. This video will be made using Adobe Premiere. The film begins providing information about the preparation for angiography and will end with the necessary care after discharge from the hospital and at home. The film will use images and animations related to angiography and will be called by one of the researchers. The contents of the educational and video materials will be based on the resources and standards related to the cerebrovascular angiography, and after the approval of the professors of the faculty of internal medicine and the neuroscience department will be used for training. B) Educational pamphlet (booklet): In the educational pamphlet, the content of the movie displayed to patients will be summarized in a written and color-coded form with pictures for patients. This booklet will be available to patients for reading. C) verbal education: verbal education will provide patients with information on cerebrovascular angiography, how to do it and its related care as a lecture and verbal to the candidate for cerebrovascular angiography. D) Answering patient questions: At the end, patients are requested to ask questions if they need additional information, as well as express their concerns. Their questions will be answered and the relevant information will be provided to them. Intervention in the intensive care unit will be performed on the cerebral  angiography in Firoozgar Hospital. After admission to this section, patients will be prepared for brain angiography. Intervention at the time of hospitalization in patients and at least 30 minutes in a room designed to patients education. Since cerebrospinal angiography is performed in the morning and afternoon shifts and on non-holiday days, interventions will take place in the morning and evening shifts of non-holiday days.</i_keyword>
      <i_keyword>The control group will not receive any educational intervention. This group will receive only the routine method in the department. Routine measures include: a) informed consent of patients about performing angiography; b) cleaning the skin; insertion of the catheter; c) taking the peripheral vessel; d) administering the drug in accordance with the relevant physician's orders; c) monitoring the vital signs every two hours before and after cerebral angiography.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: before and after intervention. Method of measurement: Spielberger  State Anxiety Inventory (SAI).</prim_outcome>
      <prim_outcome>Blood pressure (Systolic, diastolic). Timepoint: before and after intervention - from admission to discharge- q2hours. Method of measurement: mmHg - monitoring blood pressure.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: before and after intervention - from admission to discharge- q2hours. Method of measurement: beats per minute in the monitoring that is attached to patient.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: before and after intervention - from admission to discharge- q2hours. Method of measurement: breaths per minute in the monitoring that is attached to patient.</prim_outcome>
      <prim_outcome>Tempreture. Timepoint: before and after intervention - from admission to discharge- q2hours. Method of measurement: Centigrade - °C-  Temperature is shown by thermometer.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: before and after intervention - from admission to discharge- q2hours. Method of measurement: pulse oximeters-A finger pulse oximeter  that is attached to patient.</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>Vice chancellor for research and Technology, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-30</approval_date>
        <contact_name>School of Nursing &amp; Midwifery, Tehran University of Medical Sciences,  Nursing Ethics Committee</contact_name>
        <contact_address>Mirkhani St (East Nosrat), Tohid Sq Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
