<?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>IRCT20141026019677N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-22</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of two educational methods of multimedia (educational film) and peer education on the anxiety of patients with trans esophageal echo cardiography candidates</public_title>
      <acronym>دو روش آموزشی مولتی مدیا(فیلم آموزشی) و آموزش توسط همتا بر میزان اضطراب</acronym>
      <scientific_title>Comparison of the effect of two educational methods of multimedia (educational film) and peer education on the anxiety of patients with trans esophageal echo cardiography candidates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: We will have three groups in this research Which is a group; education by multimedia (educational video), a peer education group and a third group of control group Which will receive routine training, Randomization description: Block random assignment is done. Block random assignment means that the person belonging to the target group is unpredictable. In this study, due to the nature of the research (due to the interval of at least two weeks between the time of admission of patients and performing TEE), to prevent the interference of intervention and control groups, their allocation to the groups is selected randomly and weekly blocks. ; So that by using the cards on which the names of each of the groups are written separately is chosen randomly, which of the control, multimedia and peer groups are sampled each week, this method continues so much To reach the required sample size, Blinding description: Vote Preventing Injury and Infecting Information Starting sampling per week is subject to the TEE of all units under study last week. If not even one of the units is discharged, sampling will not be done until the TEE is completed.  In order to prevent bogus, according to the activity of three different physicians in the TEE unit, all three physicians are sampled every three days of each week. The statistical analyst also does not know the allocation of people to any of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: peer group, peer education training session for peer group patients one day before TEE, delivered by lecture and question and answer method, held at Fatemeh Zahra Hospital, Sari.To select the peer for training, before starting the study and sampling, referring to the Echo Mary Clinic, among the patients who referred to the TEE and selected according to the criteria for the peer, is selected based on the review of the text. Intervention 2: Intervention group: A multimedia group for educating multimedia group patients, educational researcher (CD) for 7 minutes and 12 seconds with introductory content and necessity of TEE diagnostic method, its procedure, possible complications and care before and after It will be shown one day before performing the TEE at the training hall of Fatemeh Zahra (S) Sari Hospital, as a group presentation. Intervention 3: Control group (control): Includes patients who use the current routine training (educational brochure) at the TEE clinic.</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 Incomplete study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Ranjbar Katie Late</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vesal University Hospital Nasibe Nursing and Midwifery Faculty</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4761759687</zip>
        <telephone>+98 11 4226 6375</telephone>
        <email>ranjbar1360.zr@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Esmaeili Ravanbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasseibeh Nursing &amp; Midwifery Facultry,Vesal Street, Amir Mazandarani Blvd, Sari, Mazandaran</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816713445</zip>
        <telephone>+98 113257230</telephone>
        <email>r.esmaeili@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having at least 18 years of age
Performing TEE for the first time in a non-emergency
The patient's willingness to participate in the educational program
Have at least reading and writing skills (elementary education)
The absence of any cognitive, visual or auditory (disorder Disturbing communication and lack of attention and understanding of training) Based on the evidence in the previous medical record and self-declaration
Being able to speak and understand Persian language
No addiction
Not having medical education or related
Unmet medical diagnosis of anxiety and depression (based on medical records)
Do not use sedative medicine 3 hours before TEE</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having experience of other invasive diagnostic methods (such as angiography) before taking trans esophageal echo cardiography
Dissatisfaction to continue with the researcher
Getting sick
Death of the patient</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: peer group, peer education training session for peer group patients one day before TEE, delivered by lecture and question and answer method, held at Fatemeh Zahra Hospital, Sari.To select the peer for training, before starting the study and sampling, referring to the Echo Mary Clinic, among the patients who referred to the TEE and selected according to the criteria for the peer, is selected based on the review of the text.</i_keyword>
      <i_keyword>Intervention group: A multimedia group for educating multimedia group patients, educational researcher (CD) for 7 minutes and 12 seconds with introductory content and necessity of TEE diagnostic method, its procedure, possible complications and care before and after It will be shown one day before performing the TEE at the training hall of Fatemeh Zahra (S) Sari Hospital, as a group presentation.</i_keyword>
      <i_keyword>Control group (control): Includes patients who use the current routine training (educational brochure) at the TEE clinic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Immediately before training, one hour before performing TEE. Method of measurement: Spielberger Anxiety Inventory.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-01</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vice-Chancellor for Research, Mazandaran University of Medical Sciences, Teacher Field,Sari Qaemshahr Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
