<?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>IRCT2015033021566N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-27</date_registration>
      <primary_sponsor>Vice Chancellor for research of Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>counseling of smoking cessation</public_title>
      <acronym></acronym>
      <scientific_title>Effect of educational-counseling program based smoking cessation on success and self – efficacy of smoking cessation in acute coronary syndrome patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18866</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cardiac disease.</hc_freetext>
      <i_freetext>Intervention group:&#13;
  Intervention consist of 2 educational – counseling quit smoking sessions for 60-45 minute.&#13;
 First session:&#13;
 This session has been held at the heart department of both the hospital. The researchers introduced themselves to patients and the individual members introduced themselves. As well as the expectations of their meetings and the meetings of the researcher explained. The meeting is preparedness and intervention. The purpose of the meeting or the incentive to quit smoking. In this session researcher provides the necessary training about the dangers of smoking, the effects of smoking on the cardiovascular system, the importance of quitting smoking, the consequences and the effects of continued smoking. Researcher used video and slides, lecture, question and answer. Then, to start the procedure, researcher asked   the question from members and asked them to think the problems encountered in quitting smoking. Researcher wrote Difficulties in quitting smoking expressed by members   on the board and discussed about them. The task of the researcher, guide and encourage people to participate in the group and is accelerating. In addition, researchers using listening skills, empathy, understanding feelings, companionship, attention and other techniques aimed at establishing a therapeutic relationship with patients. At this meeting, the researcher tries to enable patients to know problems and share them with each other and their counterparts are the problems and experiences .After the meeting thinking about your problems and ask them at the next meeting.&#13;
Second meeting:  In this session researcher asked all members to identify problems related to smoking cessation based on their stated priorities.  Based on the member’s consensus discussed about the most common problems.   Researcher used of counseling techniques such as Socratic dialogue and insight at this stage and prior stage depending on the situation.&#13;
 At the end of the meeting, the overall conclusion of the solutions provided by the participants and to answer possible questions and ambiguities phone number will be placed at the disposal of clients. The maintenance phase is the phase of the three-month follow-up done. In the meantime, follow through 6 calls for up to 3 months in a row is done every two weeks. Phone calls made by a colleague. Self-efficacy and successfully questionnaire completed during a call. So the information gathered, classified and then will be compared and analyzed.&#13;
Control group: In the control group were given routine care, including advice to quit smoking..</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>Zeinab Kazemzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebn-e-sina street-nursing and midewife university</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>kazemzadehz921@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Zahra Sadat Manzari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebn-e-sina street-nursing and midewife university</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>manzariz@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1. The definitive diagnosis of ACS (acute coronary syndrome) is by a specialist. 2. is willing to participate in the study. 3. have a history of smoking at least six months before admission. 4. have at least read and write. 5. be able to communicate and is fluent in Farsi. 6. mental disorder is not known because it requires the active cooperation of group counseling individuals. 7. Drug addiction is not. 8. make phone calls possible.&#13;
 Exclusion criteria: &#13;
 lack of desire to continue to cooperate and participate in training sessions - consulting group</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I51.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>I51.9</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:&#13;
  Intervention consist of 2 educational – counseling quit smoking sessions for 60-45 minute.&#13;
 First session:&#13;
 This session has been held at the heart department of both the hospital. The researchers introduced themselves to patients and the individual members introduced themselves. As well as the expectations of their meetings and the meetings of the researcher explained. The meeting is preparedness and intervention. The purpose of the meeting or the incentive to quit smoking. In this session researcher provides the necessary training about the dangers of smoking, the effects of smoking on the cardiovascular system, the importance of quitting smoking, the consequences and the effects of continued smoking. Researcher used video and slides, lecture, question and answer. Then, to start the procedure, researcher asked   the question from members and asked them to think the problems encountered in quitting smoking. Researcher wrote Difficulties in quitting smoking expressed by members   on the board and discussed about them. The task of the researcher, guide and encourage people to participate in the group and is accelerating. In addition, researchers using listening skills, empathy, understanding feelings, companionship, attention and other techniques aimed at establishing a therapeutic relationship with patients. At this meeting, the researcher tries to enable patients to know problems and share them with each other and their counterparts are the problems and experiences .After the meeting thinking about your problems and ask them at the next meeting.&#13;
Second meeting:  In this session researcher asked all members to identify problems related to smoking cessation based on their stated priorities.  Based on the member’s consensus discussed about the most common problems.   Researcher used of counseling techniques such as Socratic dialogue and insight at this stage and prior stage depending on the situation.&#13;
 At the end of the meeting, the overall conclusion of the solutions provided by the participants and to answer possible questions and ambiguities phone number will be placed at the disposal of clients. The maintenance phase is the phase of the three-month follow-up done. In the meantime, follow through 6 calls for up to 3 months in a row is done every two weeks. Phone calls made by a colleague. Self-efficacy and successfully questionnaire completed during a call. So the information gathered, classified and then will be compared and analyzed.&#13;
Control group: In the control group were given routine care, including advice to quit smoking.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Success of smoking cessation. Timepoint: before intervention to 3 mounths after intervention. Method of measurement: success of smoking cessation questionnarie.</prim_outcome>
      <prim_outcome>Self-efficacy of smoking cessation. Timepoint: before intervention to 3 mounths after intervention. Method of measurement: smoking abstinence self-efficacy questionnarie(SASEQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nicotine dependence. Timepoint: Every two weeks to 3 months2 weeks. Method of measurement: Fagereshtrum questioanarie.</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 of Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-02</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>cross way of doctors-Ebn Sina street-university of nursing and midwife mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
