<?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>IRCT2012090510749N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-10-25</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of including a component of distant learning into empathy training</public_title>
      <acronym></acronym>
      <scientific_title>A randomized controlled trial on the effectiveness of including a component of distant learning into communication skill training program compared to attending the workshop, in improving empathy of the first year residents of psychiatry</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>14</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11166</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Basic communication skills &amp; empathy.</hc_freetext>
      <i_freetext>Intervention 1: Attending group: Training basic communication skills and empathy in a two-day workshop performed by a board certified psychiatrist. The first day of the workshop includes a 2-hour lecture on basic communication skills and one role playing on “clinical setting and basic communication skills in therapeutic relationship”. The second day of the workshop includes two different role plays on “getting information from patient” and “giving information to patient”. All of the role plays of the two-day workshop are performed twice; first, with some mistakes and negative points in the performance of the “physician”, and then in a professionally correct manner. After the “flawed” performance, residents discuss the negative points with the instructor. Furthermore, each session ends with a group discussion on the topics of that session. Intervention 2: Distant learning group: Training basic communication skills and empathy by watching the videotape of the first day and participation in the second day of a two-day workshop performed by a board certified psychiatrist. The first day of the workshop includes a 2-hour lecture on basic communication skills and one role playing on “clinical setting and basic communication skills in therapeutic relationship”. The second day of the workshop includes two different role plays on “getting information from patient” and “giving information to patient”. All of the role plays of the two-day workshop are performed twice; first, with some mistakes and negative points in the performance of the “physician”, and then in a professionally correct manner. After the “flawed” performance, residents discuss the negative points with the instructor. Furthermore, each session ends with a group discussion on the topics of that session.</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>Mojgan Behzadipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Institute of Psychiatry, Shahid Mansouri Lane, Niayesh Street, Sattarkhan Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6655 1515</telephone>
        <email>m_behzadipour@razi.tums.ac.ir, mojgan_beh@yahoo.com, ahjalali@tums.ac.ir, vshariat@tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan Behzadipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Institute of Psychiatry, Shahid Mansouri Lane, Niayesh Street, Sattarkhan Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6650 6862</telephone>
        <email>m_behzadipour@razi.tums.ac.ir, mojgan_beh@yahoo.com, ahjalali@tums.ac.ir, vshariat@tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: First year residents of psychiatry; Giving consent for the study&#13;
Exclusion Criteria: Not giving consent for the study; Not participating in the sessions of the workshop</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Attending group: Training basic communication skills and empathy in a two-day workshop performed by a board certified psychiatrist. The first day of the workshop includes a 2-hour lecture on basic communication skills and one role playing on “clinical setting and basic communication skills in therapeutic relationship”. The second day of the workshop includes two different role plays on “getting information from patient” and “giving information to patient”. All of the role plays of the two-day workshop are performed twice; first, with some mistakes and negative points in the performance of the “physician”, and then in a professionally correct manner. After the “flawed” performance, residents discuss the negative points with the instructor. Furthermore, each session ends with a group discussion on the topics of that session.</i_keyword>
      <i_keyword>Distant learning group: Training basic communication skills and empathy by watching the videotape of the first day and participation in the second day of a two-day workshop performed by a board certified psychiatrist. The first day of the workshop includes a 2-hour lecture on basic communication skills and one role playing on “clinical setting and basic communication skills in therapeutic relationship”. The second day of the workshop includes two different role plays on “getting information from patient” and “giving information to patient”. All of the role plays of the two-day workshop are performed twice; first, with some mistakes and negative points in the performance of the “physician”, and then in a professionally correct manner. After the “flawed” performance, residents discuss the negative points with the instructor. Furthermore, each session ends with a group discussion on the topics of that session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Empathy. Timepoint: Before and 3 month after the training. Method of measurement: Jefferson Scale of Empathy.</prim_outcome>
      <prim_outcome>Empathy. Timepoint: Before and 3 month after the training. Method of measurement: Objective Assessment of Empathy.</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, Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-08-15</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>6th floor, the Central Campus  of the Tehran University of Medical Sciences, Ghods Street, Keshavarz Blvd Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
