<?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>IRCT20181006041254N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-03</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cognitive- behavioral counseling on the sexual compatibility in the newly wed couples</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cognitive- behavioral counseling on the sexual compatibility in the newly wed couples: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34386</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: There are two groups of intervention and control that only the intervention group will receive education and counseling, Randomization description: A simple randomization method will be used to implement random assignment. In such a way that 80 consecutive (Since each pair is wedded,A number will be considered for For 1 paired ) numbers are written on a separate paper and placed in a container. The even numbers will be assigned to group A (control) and the individual numbers will be grouped into group B (intervention). To assimilate the number of choices in the groups, the numbers removed will not be returned to the dish. Lack of information  of those who are responsible for assigning participants to study groups, in each group prevents the impact of these participants and the possibility of changing persons of by the researcher or anyone else.Participants are unaware of the quiddity of the control or intervention of A and B groups (Hiding Assignment).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual compatibility.</hc_freetext>
      <i_freetext>Intervention 1: Newly married couples, the list of clients Pre-Marriage Counseling Centers is selected randomly, 160 of them were screened using Dr Laal sexual compatibility scale (1396) with having sexual compatibility intermediate with score of 70 to 104 are eligible to participate in the research are selected. Then participants were randomly selected in two groups of 40 intervention group with gender segregation . Intervention group will attend 8 weekly group counseling sessions with a 120-minute cognitive-behavioral approach .After 2 months, the post-test is conducted using the mentioned scale. Intervention 2: Newly married couples, the list of clients Pre-Marriage Counseling Centers is selected randomly, 160 of them were screened using Dr Laal sexual compatibility scale (1396) with having sexual compatibility intermediate with score of 70 to 104 are eligible to participate in the research are selected. Then participants were randomly selected in two groups of 40 intervention group with gender segregation and two groups of 40 people, control group from both sexes will be selected.control group will not receive intervention. After 2 months, the post-test is conducted using the mentioned scale.</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:
All data is from the proposal, raw data and project reports

When:
Data is available from the legal system six months after publication for two years

To whom:
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kermanshah University of Medical Sciences.

Conditions:
For legal issues and the need to use data in future studies

Where to obtain:
Mitra Kolivand, Parvin Allah Yari

How to obtain:
After submitting a request to the Kermanshah Research and Technology Dept. of Science and Technology, a call for submission is given.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvin َAllahyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dolat Abad Ave</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3826 1081</telephone>
        <email>p.allahyari@muk.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Kolivand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dolat Abad Ave</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3826 1081</telephone>
        <email>mitrakolivand@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Duration of marriage from 6 months to 1 year
People willing to participate in the study
Not having a history of alcohol use and Sexual enhancement drugs
Not being treated by a gynecologist urologist and psychologist for sexual dysfunction
There are no genetic abnormalities in the anatomy and sexual function
Lack of previous marriage
Lack of diseases affecting sexual function such as diabetes
Minimum elementary level education
There is no serious problem with detected sexual incompatibility
Lack of pregnancy</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not attending in meetings 2 times or more
Incomplete answers or completion of the questionnaire halfway
Lack of consent of the individual to continue participating in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Either the prospect of sexual interaction produces sufficient fear or anxiety that sexual activity is avoided (sexual aversion) or sexual responses occur normally and orgasm is experienced but there is a lack of appropriate pleasure (lack of sexual enjoym</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Newly married couples, the list of clients Pre-Marriage Counseling Centers is selected randomly, 160 of them were screened using Dr Laal sexual compatibility scale (1396) with having sexual compatibility intermediate with score of 70 to 104 are eligible to participate in the research are selected. Then participants were randomly selected in two groups of 40 intervention group with gender segregation . Intervention group will attend 8 weekly group counseling sessions with a 120-minute cognitive-behavioral approach .After 2 months, the post-test is conducted using the mentioned scale</i_keyword>
      <i_keyword>Newly married couples, the list of clients Pre-Marriage Counseling Centers is selected randomly, 160 of them were screened using Dr Laal sexual compatibility scale (1396) with having sexual compatibility intermediate with score of 70 to 104 are eligible to participate in the research are selected. Then participants were randomly selected in two groups of 40 intervention group with gender segregation and two groups of 40 people, control group from both sexes will be selected.control group will not receive intervention. After 2 months, the post-test is conducted using the mentioned scale</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual compatibility. Timepoint: Weekly for 2 months. Method of measurement: Sexual compatibility questioner of doctor Laal.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-05</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah University of Medical Sciences, Dolatabad, Kermanshah, IRAN Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
