<?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>IRCT201410236284N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-10-24</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical sciences</primary_sponsor>
      <public_title>Education based on empowerment model on thinking and  quality of life in  infertile women</public_title>
      <acronym></acronym>
      <scientific_title>The impact of the implementing of  empowerment program on the quality of life and thoughts in infertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6737</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention is based on empowerment model which has four steps: knowledge, self-efficacy, training participation and evaluation. The first step (perceived threat) empowerment program will try to increase awareness and understanding of the nature and consequences of the infertility. The first step is two hours instructive sessions with a week interval. The second step which is problem solving, is two hours group discussion sessions under the supervision of the researcher and a psychologist(Group discussions and choose the best solution). In the third step (educational participation), will try to increase the efficacy through educational participation. The fourth step is evaluation done in two stages. The first stage involve asking two questions orally at the beginning of each session and The second stage is the final evaluation that instruments will be completed again by the sample. The meeting will be held in the form of individual and group(5 sessions of group and 2 individual sessions). Group meetings are once a week and Individual sessions are times that women come to evaluate the fertility and the aims of Individual sessions is for basic familiarity with each women and answer demographic questionnaire and evaluation of basic capacity and quality of life. Intervention 2: The control group only received the routine therapies and services of the fertility center. No counseling was included for this group.</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>Dr. Modares Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery Tehran University of Medical Science, Tohid square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>modarres@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Modares Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery Tehran University of Medical Science, Tohid square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 212166927171</telephone>
        <email>modarres@sina.tums.ac.ir</email>
        <affiliation>Tehran 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: infertility due to female factore; primary infertility; literacy;  Iranian;  Muslim;  Lack of physical and mental illness; aged 18 to 40  years. Exclusion criteria: physical and mental illness identified;  become pregnant during the study; not participate in all meetings of the intervention .</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention is based on empowerment model which has four steps: knowledge, self-efficacy, training participation and evaluation. The first step (perceived threat) empowerment program will try to increase awareness and understanding of the nature and consequences of the infertility. The first step is two hours instructive sessions with a week interval. The second step which is problem solving, is two hours group discussion sessions under the supervision of the researcher and a psychologist(Group discussions and choose the best solution). In the third step (educational participation), will try to increase the efficacy through educational participation. The fourth step is evaluation done in two stages. The first stage involve asking two questions orally at the beginning of each session and The second stage is the final evaluation that instruments will be completed again by the sample. The meeting will be held in the form of individual and group(5 sessions of group and 2 individual sessions). Group meetings are once a week and Individual sessions are times that women come to evaluate the fertility and the aims of Individual sessions is for basic familiarity with each women and answer demographic questionnaire and evaluation of basic capacity and quality of life.</i_keyword>
      <i_keyword>The control group only received the routine therapies and services of the fertility center. No counseling was included for this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Pre test, 3 months after intervention. Method of measurement: Quality of life questionnare.</prim_outcome>
      <prim_outcome>Irrational parentrhood cognitions. Timepoint: Pre test, 3  month after intervention. Method of measurement: Irrational parentrhood cognitions scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Psychological aspect of the quality of life. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Physical aspect of the quality of life. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Social aspect of the quality of life. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Sexual aspect of quality of life. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Spirituality aspect of the quality of life. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Economic aspect of the quality of life. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Emotional  aspect quality of life. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Irrational parentrhood cognitions. Timepoint: Pre test and 12 weeks  after intervention. Method of measurement: Irrational parentrhood cognitions scale.</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, Tehran University of Medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-03-04</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical sciences</contact_name>
        <contact_address>6th floor, Central organization of University, edge of Qods avenue, Keshavarz blvd, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
