<?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>IRCT2015120825438N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-25</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>marital counseling</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of group versus integrated (individual and group)  counseling of women on quality gap in marital counseling and attitudes toward childbearing from the perspective of them</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Other</recruitment_status>
      <url>https://irct.ir/trial/21276</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>marital counseling.</hc_freetext>
      <i_freetext>Intervention 1: In the group receiving marriage counseling group , three two-hour sessions to be held within a week . The six hours of discussions are about  Emotional and sexuality relationships, health care related to pregnancy and childbearing. &#13;
In fact, in this Intervention  the presentation of two hours of premarital counseling classes at health centers has increased to six hours. Moreover, the method of presentation is Counseling that is based on client need to spend the training mode is active.&#13;
To provide group counseling principles and techniques needed to be trained researcher.&#13;
The topic of childbearing , which is now a major issue in our country on the issue of family planning is an alternative intervention. Intervention 2: In the group receiving combination counseling (the combination of group and individual counseling ), three two-hour sessions to be held within a week.&#13;
Four hours of group counseling and individual counseling is two hours.&#13;
Content of emotional and sexuality relationships, health care related to pregnancy and childbearing in four hours using techniques group counseling will be provided.&#13;
Two hours of individual counseling is also given time to client to obtain information about  content and receive answers.&#13;
People who have serious problems in the field of the above issues will be referred to a psychologist.</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>Seyyedeh Adeleh Rahmanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing – Midwifery, Doktora Crossroads, Daneshgah St</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>nms.it[at]mums.ac.ir; rahmaniana921@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Talat Khadivzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing – Midwifery, Doktora Crossroads, Daneshgah St</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>nms.it[at]mums.ac.ir; khadivzadeht@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for this study include: Iranian and resident of the city of Mashhad; have a consent to participate in research; be literate; mental and physical disabilities or pshycological disorders that hinder learning is obvious; dont exit.&#13;
 Exclusion criteria were as follows: women who have remarried; there is no desire to continue research; not to fully participate in counseling sessions (Absence of more than ninety minutes of meetings).</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XXI</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Factors influencing health status and contact with health services</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the group receiving marriage counseling group , three two-hour sessions to be held within a week . The six hours of discussions are about  Emotional and sexuality relationships, health care related to pregnancy and childbearing. &#13;
In fact, in this Intervention  the presentation of two hours of premarital counseling classes at health centers has increased to six hours. Moreover, the method of presentation is Counseling that is based on client need to spend the training mode is active.&#13;
To provide group counseling principles and techniques needed to be trained researcher.&#13;
The topic of childbearing , which is now a major issue in our country on the issue of family planning is an alternative intervention.</i_keyword>
      <i_keyword>In the group receiving combination counseling (the combination of group and individual counseling ), three two-hour sessions to be held within a week.&#13;
Four hours of group counseling and individual counseling is two hours.&#13;
Content of emotional and sexuality relationships, health care related to pregnancy and childbearing in four hours using techniques group counseling will be provided.&#13;
Two hours of individual counseling is also given time to client to obtain information about  content and receive answers.&#13;
People who have serious problems in the field of the above issues will be referred to a psychologist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality gap in marital counseling. Timepoint: Beginning of the first session - End of third session. Method of measurement: Derived from the Servqual questionnaire.</prim_outcome>
      <prim_outcome>Attitudes toward childbearing. Timepoint: Beginning of first session - A week after third session. Method of measurement: attitude to childbearing questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Attitude to emotional relationships couples. Timepoint: The beginning of the first session - the end of the third session. Method of measurement: couples' emotional relationship questionnaire.</sec_outcome>
      <sec_outcome>Knowledge and attitudes to sexual relationships. Timepoint: The beginning of the first session - the end of the third session. Method of measurement: Skas questionnaire.</sec_outcome>
      <sec_outcome>Knowledge and attitude to healthy pregnancy. Timepoint: Beginning of the first session - A week after  third session. Method of measurement: knowledge and attitude to healthy pregnancy questionnaires.</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, Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-07</approval_date>
        <contact_name>Ethics Committee Mashhad University of Medical Sciences</contact_name>
        <contact_address>Administration Center(Qoreishi Building), Daneshgah St, Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
