<?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>IRCT20180120038453N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-06</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of training on stress, anxiety,depression and self-efficacy in patients with pacemakers and cardiopulmonary defibrillator</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison effect of Group Discussion and Video-Learning on Stress, anxiety,depression and self-efficacy in patients undergoing Pacemaker and Implantable- Cardioverter Defibrillator</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29269</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After the device was fitted, the informed consent form was given to qualified patients willing to participate in the study, and after completing the pre-test written permission and ensuring the confidentiality of the information, a demographic information questionnaire for the patients was completed.After completing initial information and rejection of psychiatric diseases, if the patient was at the age group and the patient or first-degree relatives were not part of the medical staff, they were divided into three groups based on the age group and date of the device, and according to the necessity Group discussion sessions were held for the video, the beginning of training with the group was discussed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with pacemakers or cardiac implantation defibrillators.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Learning by group discussion method : After calling patients and forming groups of 10-6, structured training was started during a 2-hour session at the conference hall of Shahid Beheshti Hospital with the participation of researchers after the completion of the initial questionnaires. Intervention 2: Intervention group 2: Video tutorial: After filming the content provided by the researchers in the group discussion group and reviewing and editing, a compact disc prepared from each session is reviewed by three qualified individuals (an educational expert and two cardiologists) in the minimum possible time (7-10 days). And confirmed and presented to the video tutoring group in person after completion of the initial questionnaires. The approximate duration of the video was about an hour and fifteen minutes. Intervention 3: Control group: Routine tutorial: This group did not receive any educational intervention except for a manual and explanations provided by the department to all patients (even two educational groups).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Allahyar Golabchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gotbe Ravandi Blvd</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8741135911</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>s.sokoutmedical89@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Allahyar Golabchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotbe Ravandi Blvd.</address>
        <city>Kashsn</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8741135911</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>s.sokoutmedical89@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients who are first implanted with pacemakers or cardiac defibrillators.
They tended to participate in the study.
Were in the age group of 18-75 years old.
No psychiatric illness.
The patient himself or his relatives were not members of the health team.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient died during the study.
During the study, you should not cooperate with the researcher
An unfortunate event that adds to anxiety and reduces self-efficacy.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z95.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of cardiac pacemaker</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Learning by group discussion method : After calling patients and forming groups of 10-6, structured training was started during a 2-hour session at the conference hall of Shahid Beheshti Hospital with the participation of researchers after the completion of the initial questionnaires.</i_keyword>
      <i_keyword>Intervention group 2: Video tutorial: After filming the content provided by the researchers in the group discussion group and reviewing and editing, a compact disc prepared from each session is reviewed by three qualified individuals (an educational expert and two cardiologists) in the minimum possible time (7-10 days). And confirmed and presented to the video tutoring group in person after completion of the initial questionnaires. The approximate duration of the video was about an hour and fifteen minutes.</i_keyword>
      <i_keyword>Control group: Routine tutorial: This group did not receive any educational intervention except for a manual and explanations provided by the department to all patients (even two educational groups).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress score in the questionnaire DASS21. Timepoint: At the beginning of the study (before the training) and three weeks after the training. Method of measurement: Stress questionnaire DASS21.</prim_outcome>
      <prim_outcome>Anxiety score in the questionnaire DASS21. Timepoint: At the beginning of the study (before the training) and three weeks after the training. Method of measurement: Anxiety questionnaire DASS21.</prim_outcome>
      <prim_outcome>Depression score in the questionnaire DASS21. Timepoint: At the beginning of the study (before the training) and three weeks after the training. Method of measurement: Depression questionnaire DASS21.</prim_outcome>
      <prim_outcome>Self-efficacy scores in self-efficacy questionnaire for patients with pacemakers. Timepoint: At the beginning of the study (before the training) and three weeks after the training. Method of measurement: Self-efficacy questionnaire for patients with pacemakers.</prim_outcome>
      <prim_outcome>Self-efficacy score in patients self-efficacy questionnaire has Cardiac implantable cardioverter defibrillator. Timepoint: At the beginning of the study (before the training) and three weeks after the training. Method of measurement: Self-efficacy questionnaire for patients with implantable cardioverter defibrillator.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-22</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Kashan University of Medical Sciences Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
