<?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>IRCT20190809044485N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-01</date_registration>
      <primary_sponsor>College of Nursing, University of Baghdad</primary_sponsor>
      <public_title>Targeting Smoking Triggers: A Tailored Nurse-led Intervention for Controlling Tobacco Smoking</public_title>
      <acronym>Targeting Smoking Triggers Trial(TSTT)</acronym>
      <scientific_title>Influence of A Tailored Nurse-Led Intervention on Controlling Tobacco Smoking</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>750</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44600</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to maintain a transparent &amp; scientific-based randomization process, simple randomization will be used in assigning participants (individuals: Active smokers), to treatment &amp; control groups, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve throwing a dice (eg, below &amp; equal to 3  =  control, over 3  =  treatment). No allocation concealment will be carried out.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tobacco Cigarettes Smoking Dependence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The starting point of the intervention phase will start by asking the subjects to respond to “why do you smoke” questionnaire (American Lung Association, 1993). This mandatory step will help in categorizing the subjects according to their smoking trigger. Intervention group subjects will be armed with orally &amp; in a written form of simple, yet specific instructions to enable them managing their dominant smoking trigger. The intervention group will be contacted after 14 days to see the influence of the given instruction on their smoking status. Intervention 2: Control group: In order to be matched with subjects in the intervention group, control group subjects smoking dominant trigger will be determined. No instructions will be given to them during the study course.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.

When:
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications

To whom:
All the related files will be shared with any scientific interested parties.

Conditions:
It may be used after seeking the author's permission and acknowledging his contribution.

Where to obtain:
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: s.al-fayyadh@conursing.uobaghdad.edu.iq

How to obtain:
N/A

Comments:
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sadeq AL-Fayyadh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al Karkh, Ajnadine neighborhood, House No 3, Street No 62, Section No 863</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>10001</zip>
        <telephone>+964 1 521 1494</telephone>
        <email>s.al-fayyadh@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad, College of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadeq AL-Fayyadh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al Karkh, Ajnadine neighborhood, House No 3, Street No 62, Section No 863</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>10001</zip>
        <telephone>+964 1 521 1494</telephone>
        <email>s.al-fayyadh@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad, College of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent &amp; compliance with all aspects of the study protocol, methods, providing data during follow-up phase
Contact male &amp; female patients, who are 18-70 years old at the time of data collection phase</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Involvement with any other ongoing studies.
Medically diagnosed with psycho-mental diseases
Morbidly ill subjects, whereas their physical &amp; mental capacity are impaired</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F17.21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nicotine dependence, cigarettes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The starting point of the intervention phase will start by asking the subjects to respond to “why do you smoke” questionnaire (American Lung Association, 1993). This mandatory step will help in categorizing the subjects according to their smoking trigger. Intervention group subjects will be armed with orally &amp; in a written form of simple, yet specific instructions to enable them managing their dominant smoking trigger. The intervention group will be contacted after 14 days to see the influence of the given instruction on their smoking status.</i_keyword>
      <i_keyword>Control group: In order to be matched with subjects in the intervention group, control group subjects smoking dominant trigger will be determined. No instructions will be given to them during the study course.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Smoking Tobacco Cigarettes (Quitting or Reducing). Timepoint: Subjects response to the educational intervention will be within two weeks of the first meeting to examine the effectiveness of the intervention on smoking habit. Method of measurement: Self-report of smoking status after being exposed to the educational intervention.</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>The author of the trial is the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-21</approval_date>
        <contact_name>Research Ethical Approval Committee, at the College of Nursing</contact_name>
        <contact_address>Bab AL-Muadum Baghdad Baghdad Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
