<?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>IRCT20120821010635N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-28</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self care counseling on self care practice and health locus of control belief in pregnant women aged 35 years or older</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self care counseling on self care practice and health locus of control belief in pregnant women aged 35 years or more in the test and control groups</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11092</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: In this study, the participants at first will be selected by simple sampling method and then will be divided randomly into control and experimental groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Self care.</hc_freetext>
      <i_freetext>Intervention 1: "Test group": The counseling schedule will take place in the form of GATHER, so that after greetings and establishing a good relationship with mothers and greeting (G), asking the mothers open questions about themselves to help them think and reflect on the subject of the study. Give references to the wishes and needs and help mothers express their feelings and beliefs and get information about the risk of pregnancy and its complications (A) and provide the necessary explanation (T). Second session (45-60 minutes): To help the research units to increase the information about self-care during pregnancy and how to control health by emphasizing its internal aspect, counseling in La The ground will be presented. Identify the negative thoughts and misconceptions about health. Help (H) The third session (45-60 minutes): During this session, while reviewing the topics of the previous sessions and answering the questions, counseling on self-care during pregnancy and your individual role in health care. Educational pamphlets and educational explanations (E), scheduling for a visit to mothers, determining the next visit, if necessary, and explaining to the mother about follow-up times and weekly contacts (R).                                            There will be no intervention in the control group. Intervention 2: "Control group": There will be no intervention in the control 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
In this research, after the initial permission of individuals and their unidentified, research data will be shared.

When:
The data will be shared after the statistical analysis from the second half of 1397.

To whom:
Data will be shared by researchers in relevant fields.

Conditions:
Any use of data will be subject to obtaining permission from Hamadan University of Medical Sciences.

Where to obtain:
Responsive name is Dr. Soodabeh Aghababii, Faculty Member of University of Hamadan Medical Sciences.
E-mail: aghababaii@yahoo.com

How to obtain:
Data will be available upon notification of the respondent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soodabeh Aghababaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Hamadan Medical Sciences, Shahid Fahmideh Ave, Hamadan, Iran.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65178- 38698</zip>
        <telephone>+98 81 3838 0150</telephone>
        <email>aghababaii@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soodabeh Aghababaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Hamadan Medical Sciences, Shahid Fahmideh Ave, Hamadan, Iran.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65178- 38698</zip>
        <telephone>+98 81 3838 0150</telephone>
        <email>aghababaii@yahoo.com</email>
        <affiliation>University of Hamadan Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria includes: Pregnant women with 35 years or more;  having no underlying illnesses; single pregnancy; gestational age more than 24 weeks; Have primary and higher literacy.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria includes: Having not complete health based on medical records.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z40- Z54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Persons encountering health services for specific procedures and health care</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Test group": The counseling schedule will take place in the form of GATHER, so that after greetings and establishing a good relationship with mothers and greeting (G), asking the mothers open questions about themselves to help them think and reflect on the subject of the study. Give references to the wishes and needs and help mothers express their feelings and beliefs and get information about the risk of pregnancy and its complications (A) and provide the necessary explanation (T). Second session (45-60 minutes): To help the research units to increase the information about self-care during pregnancy and how to control health by emphasizing its internal aspect, counseling in La The ground will be presented. Identify the negative thoughts and misconceptions about health. Help (H) The third session (45-60 minutes): During this session, while reviewing the topics of the previous sessions and answering the questions, counseling on self-care during pregnancy and your individual role in health care. Educational pamphlets and educational explanations (E), scheduling for a visit to mothers, determining the next visit, if necessary, and explaining to the mother about follow-up times and weekly contacts (R).                                            There will be no intervention in the control group.</i_keyword>
      <i_keyword>"Control group": There will be no intervention in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self care score. Timepoint: At the beginning of the study (before the intervention) and 30 days after the end of the intervention. Method of measurement: Use the Health Practice Ouestionnaire.</prim_outcome>
      <prim_outcome>Health Locus of Control score. Timepoint: At the beginning of the study (before the intervention) and 30 days after the end of the intervention. Method of measurement: Use the Health Locus of Control ُScale (HLC).</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-14</approval_date>
        <contact_name>The Ethics committee of University of Hamadan Medical Sciences</contact_name>
        <contact_address>University of Hamadan Medical Sciences, Shahid Fahmideh Ave, Hamadan, Iran. Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
