<?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>IRCT2014071518499N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-10-06</date_registration>
      <primary_sponsor>Tehran University of Medical sciences Vice chancellor for research</primary_sponsor>
      <public_title>Effect of Nicotine and Consulting on smoking cessation and pulmonary indexes in patients candidate for heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Nicotine Replacement Therapy (NRT) and Nursing consulting on smoking cessation and Spiro metric  indexes of smokers candidate for Coronary Artery Bypass Graft (CABG)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16764</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Smokers Candidate for Coronary artery Bypass Graft surgery (CABG).</hc_freetext>
      <i_freetext>Intervention 1: In NRT group, at the beginning of participation, researcher will explain instructions and dosage of using nicotine gums for patients and their family. Then we will give patients two boxes of gums till the time of surgery, which contain 30 gums in each box and each gum, provide 2mg nicotine. During hospitalization days which are near one week, we will use nicotine patches. Each patch is for daily use and contains 17.5 mg nicotine. After that on the time of discharge, two other boxes of gums will be given to them for their demands on non-hospitalization days. This dosage has approved by experts of cessation center and physicians. (Since hospitalization and postoperative conditions may cause some limitations for using nicotine gums, it's better to use patches instead, in these days which are better for observing amount of NRT that has been used). We will give participants a phone number for contact to researcher and report their allergic reactions, and other problems which make them unable to cooperate with study and also for extra questions. Intervention 2: In consulting group, intervention will be accomplished by phone-consulting (in 10-15 minutes duration each time) and 3 times a week, in non-hospitalization days. (For hospitalization days consults will do in presence). Consults will be done in organized and scheduled method. At the beginning, researcher will examine patients and their family needs for consulting. After that, in each telephone contacts according to their needs, researcher will explain for them, smoking risk factors, cessation benefits, cessation withdrawal symptoms and ways to encounter with them. Researcher also will assess participants' trends for quit smoking, stresses and problems that they encounter with about quitting, then will try to persuade them for cessation and try to remain on it. Also we will give a phone number to participants for contact researcher if necessary.</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>Fateme Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Dr. Mirkhani St., (East Nosrat) , Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 35 1620 4053</telephone>
        <email>f_bakhshi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of medical Sciences- School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Shokooh Varaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Dr. Mirkhani St., (East Nosrat) , Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>shvaraei@sina.tums.ac.ir</email>
        <affiliation>Tehran University of medical Sciences- School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: 1. Age 18 years or more 2. Patients tend to have quit smoking 3. Candidates of CABG surgery 4. Non-emergency CABG surgery 5. Smoking addiction 6. No history of mental disorder or having psychologically Cooperation 7. Not allergic to nicotine patches and gum 8. Ability to properly use of nicotine patches 9. Non-use of other cessation forms 10. Have no Addiction to alcohol and other drugs 11. Not having acute or severe respiratory disorders Exclusion Criteria: 1. Occurrence of unstable medical conditions and inability to continue cooperation in the study. 2. Refuse cooperation in study or continue smoking during the study period 3. Conflict to other postoperative complications in such a way that makes it impossible to continue study participation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In NRT group, at the beginning of participation, researcher will explain instructions and dosage of using nicotine gums for patients and their family. Then we will give patients two boxes of gums till the time of surgery, which contain 30 gums in each box and each gum, provide 2mg nicotine. During hospitalization days which are near one week, we will use nicotine patches. Each patch is for daily use and contains 17.5 mg nicotine. After that on the time of discharge, two other boxes of gums will be given to them for their demands on non-hospitalization days. This dosage has approved by experts of cessation center and physicians. (Since hospitalization and postoperative conditions may cause some limitations for using nicotine gums, it's better to use patches instead, in these days which are better for observing amount of NRT that has been used). We will give participants a phone number for contact to researcher and report their allergic reactions, and other problems which make them unable to cooperate with study and also for extra questions.</i_keyword>
      <i_keyword>In consulting group, intervention will be accomplished by phone-consulting (in 10-15 minutes duration each time) and 3 times a week, in non-hospitalization days. (For hospitalization days consults will do in presence). Consults will be done in organized and scheduled method. At the beginning, researcher will examine patients and their family needs for consulting. After that, in each telephone contacts according to their needs, researcher will explain for them, smoking risk factors, cessation benefits, cessation withdrawal symptoms and ways to encounter with them. Researcher also will assess participants' trends for quit smoking, stresses and problems that they encounter with about quitting, then will try to persuade them for cessation and try to remain on it. Also we will give a phone number to participants for contact researcher if necessary.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Smoking Cessations. Timepoint: Measurements time intervals: Smoking cessation: It will be monitored according to time table. In the way that, during 3 weeks before and till 3 weeks after surgery which is research time table, we will contact to patients and their families separately 2-3 times a week for examining adherence to cessations. Method of measurement: For smoking cessation: telephone contacts to patients and their families according to time table.</prim_outcome>
      <prim_outcome>Patients' Spirometric Indexes. Timepoint: Spirometric indexes: examinations of patients' pulmonary indexes and function by computerized spirometry test in two times (one day before surgery and 2 weeks after that). Method of measurement: For spirometric indexes: by spirometry Device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Demographic data and medical history. Timepoint: at the beginning of study in physician clinic. Method of measurement: by interviewing and questionnaire.</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>Tehran University of Medical sciences Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-25</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences.</contact_name>
        <contact_address>Sixth floor, in the corner of Ghods St.,  Keshavarz Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
