<?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>IRCT2017072235133N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-06</date_registration>
      <primary_sponsor>Hamadan University of Medical Sciences</primary_sponsor>
      <public_title>Impact of family-centered counseling on the smoker's mother-in-law</public_title>
      <acronym></acronym>
      <scientific_title>The effect of family-based counseling on the basis of the BASNEF model on the frequency of smoking among smokers in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26641</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tobacco abuse counselling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Of the 53 pregnant women, the smoker's home will be used as an intervention group. Intervention in smokers will also house pregnant women and there will be no intervention in pregnant women. By telephone, the consultation timetable is coordinated with the intervention group and the time for the consultation sessions is determined. In this research, intervention will be family-centered counseling. Meetings will be grouped by a maximum of 10 people. The duration of each session is about 60 minutes and the number of sessions of 4 sessions will be at least 1 week. The counseling will be conducted by the researcher in all groups based on counseling steps on reproductive health services (GATHER). The objectives of our study are as follows: Session 1: A counseling session to introduce a smoker to smoke and harmful substances to a smoker and his relatives, especially pregnant and fetus, which is synonymous with GATHER steps 1, 2 and 3. Session 2: Counseling for a smoker A few cigarette smoke explanations, including second hand smoke, active smoker and active smoker, are synonymous with steps 2 and 5 of GATHER counseling. Session 3: A counseling session for a smoker to know about the effects of cigarette smoking during childbirth, childhood and adolescence on exposure to cigarette smoke and the options available to prevent exposure of pregnant women with cigarette smoke is synonymous with GATHER steps 3, 4 and 5. Session 4: Mention the summary of the contents of the past sessions and provide queries and answers to help eliminate the ambiguities of smokers, which is synonymous with step 6 of GATHER counseling. Then, the test group will be asked to apply the principles that they are trained when attending the home and the pregnant woman. After completion of the follow-up period (one month later), the initial questionnaire is again completed by the two groups. The obtained data will be analyzed by statistical analysis. Intervention 2: Intervention group 2:The control group, like the intervention group, will consist of 53 pregnant women with a smoker's home, and there will be no intervention or training for smokers at their home.</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>Barzegar Fariba</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Hamadan University of Medical Sciensces</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone></telephone>
        <email>fa.barzegar@edu.umsha.ac.ir; barzegarfariba121@yahoo.com</email>
        <affiliation>Hamadan University of Medical Sciensces</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sangestani Gita</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Hamadan University of Medical Sciensce</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3838 0535</telephone>
        <email>gsangestani@yahoo.com</email>
        <affiliation>Hamadan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entry criteria: 1) Gestational age is less than 30 weeks of pregnancy. 2) The pregnant mother is not a smoker or a hookah. 3) Mom is exposed to smoke during the day by his or her partner in a closed home. 4) A smoker is not addicted to any type of drug.  Exit criteria: 1) Participant for any reason and at any time to opt out of cooperation. 2) The pregnant mother needs hospitalization due to physical or psychological problems.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z71.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Person consulting on behalf of another person</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Of the 53 pregnant women, the smoker's home will be used as an intervention group. Intervention in smokers will also house pregnant women and there will be no intervention in pregnant women. By telephone, the consultation timetable is coordinated with the intervention group and the time for the consultation sessions is determined. In this research, intervention will be family-centered counseling. Meetings will be grouped by a maximum of 10 people. The duration of each session is about 60 minutes and the number of sessions of 4 sessions will be at least 1 week. The counseling will be conducted by the researcher in all groups based on counseling steps on reproductive health services (GATHER). The objectives of our study are as follows: Session 1: A counseling session to introduce a smoker to smoke and harmful substances to a smoker and his relatives, especially pregnant and fetus, which is synonymous with GATHER steps 1, 2 and 3. Session 2: Counseling for a smoker A few cigarette smoke explanations, including second hand smoke, active smoker and active smoker, are synonymous with steps 2 and 5 of GATHER counseling. Session 3: A counseling session for a smoker to know about the effects of cigarette smoking during childbirth, childhood and adolescence on exposure to cigarette smoke and the options available to prevent exposure of pregnant women with cigarette smoke is synonymous with GATHER steps 3, 4 and 5. Session 4: Mention the summary of the contents of the past sessions and provide queries and answers to help eliminate the ambiguities of smokers, which is synonymous with step 6 of GATHER counseling. Then, the test group will be asked to apply the principles that they are trained when attending the home and the pregnant woman. After completion of the follow-up period (one month later), the initial questionnaire is again completed by the two groups. The obtained data will be analyzed by statistical analysis.</i_keyword>
      <i_keyword>Intervention group 2:The control group, like the intervention group, will consist of 53 pregnant women with a smoker's home, and there will be no intervention or training for smokers at their home.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Succeeding in quitting a pregnant woman's presence. Timepoint: Before intervention to 1 mounths after intervention. Method of measurement: Success Stomach Quitting Questionnaire based on BASNEF Model.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Success of smoking cessation. Timepoint: Before intervention to 1 mounths after intervention. Method of measurement: A researcher-made questionnaire measuring smoking cessation based on the BASNEF model.</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>Hamadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-23</approval_date>
        <contact_name>Hamadan University of Medical Sciences</contact_name>
        <contact_address>Nursing and Midwifery Faculty, Hamadan University of Medical Sciences, in front of Mardom Park, Shahid Fahmide Avenue, Hamadan Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
