<?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>IRCT20200516047467N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-11</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>effect of sexual counseling on the  sexual quality of  life and depression in pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of BETTER model Sexual Counseling on  sexual Quality of  Life and Depression in pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48229</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, block randomization method, which is one of the following limited randomization groups, is used. 4-block method is used to create a random allocation sequence in this study. Pregnant women will be selected according to the criteria of the researcher and are randomly assigned to the central Randomization method in two groups (intervention) and B (control).In order to perform this task, the sequencing website will be created by random blocks.In this study, by using the software, by the methodology consultant, the random allocation sequence is obtained., in this study, the random sequence of blocks will be provided to the specific of the research team, which is responsible for the random allocation.With the arrival of mothers to study and register them at any centre, at the same time, all persons and their conditions will be recorded in a central list, and they will receive a code in order to log in.Then it is responsible for the allocation of codes to receive and assign people to intervention and control groups.Mhaghqbrasas the entry of participants to study with the relevant center and questions about the random allocation of the participant to the study group.Communication methods include using your phone, message, fax, email, etc.</study_design>
      <phase>N/A</phase>
      <hc_freetext>depression during pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the case of two weeks, a 45-minute sex consultation with a one-week interval is performed individually for mothers 14-25 weeks pregnant in the intervention group.Each session is based on this model including 6 steps: 1-bieng-2-explain about whether sexual relationship is part of quality of life-3-tell a bout their concerns in the future-4-time of intervention-5-education-6-Record of interventions. Intervention 2: Control group: recieves routine care.</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:
The entire potential data is unidentifiable after being detected by peopl

When:
6 months after printing results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Those who are allowed to submit an application for personally identifiable information with other documents

Where to obtain:
Shahroud University of Medical Sciences maral forqani far

How to obtain:
6months of Waiting

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maral Forqani far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rahbari st,saadi</address>
        <city>Likak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>757554459</zip>
        <telephone>+98 74 3282 2262</telephone>
        <email>Maralforqanifar@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maral Forqani far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rahbari st,saadi</address>
        <city>Likak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>757554459</zip>
        <telephone>+98 74 3282 2262</telephone>
        <email>maralforqanifar@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnancy required in the second trimester of pregnancy (15 weeks to 25 weeks
Age 18-35 years
Have a minimum of literacy
Do not use drugs or alcohol
Have no chronic mental illness before and during pregnancy
No history of miscarriage or infant death
Single infant
No history of infertility or pregnancy with assisted reproductive techniques(ART)
There are no pregnancy problems such as prolactinemia or fetal problems such as weight loss
dont have Sexual disease before and now
Depression scores below 12 with EPDS</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Have diabetes
Take drugs that affect the sexual cycle
Marital disputes or abstinence from partner for any reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F33.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, recurrent, moderate</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the case of two weeks, a 45-minute sex consultation with a one-week interval is performed individually for mothers 14-25 weeks pregnant in the intervention group.Each session is based on this model including 6 steps: 1-bieng-2-explain about whether sexual relationship is part of quality of life-3-tell a bout their concerns in the future-4-time of intervention-5-education-6-Record of interventions</i_keyword>
      <i_keyword>Control group: recieves routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual quality of life. Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: Sexual quality of life questionnaire is a means that the linking of the quality of sexual function, women in the life of females.It is a report that focuses on the confidence of the relationship between women, emotional and communicative beliefs.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: Edinburgh Depression Questionnaire is used to measure depression during pregnancy and postpartum period.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-09</approval_date>
        <contact_name>Ethics committee of Shahroud university  of medical sciences</contact_name>
        <contact_address>7 tir str uni shmu Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
