<?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>IRCT20220424054637N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-18</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The efficacy of Tele-based sexuality councelling on sextual function  and sextual distress of primiparous women with exclusive breastfeeding and their spouses</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of Tele-based sexuality councelling on sextual function  and sextual distress of primiparous women with exclusive breastfeeding and their spouses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65055</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: We will use block of four for random allocation. In order to determine the sequence of allocation by the four block method, random allocation sequence generation software will be used. In order to hide the sequence of allocation, the papers identifying the group of people are placed inside the envelopes in the opaque package and coded in the same order. In this case, a questionnaire with the same code will be completed for the person who receives the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sextual function  , Sextual distress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before the intervention, the  questionnaire link will be sent through the "Whatsapp "application and the people will be coded. In addition to routine postpartum care, the intervention group will receive five counseling sessions through video calls on "Whatsapp" messenger. Sessions include couples and counselors (three people). "My wife" book (skill training in marital and sexual relations) and the textbook of sexual disorders are considered as educational resources. Counseling sessions are held every 5 days, and after the end of each counseling session, a phone call is made in order to explain more about the training and not to forget the exercises within five days until the next counseling session. Videos, images and educational content related to each session will be provided to couples through social messengers. Intervention 2: Control group :the usual postpartum care will be received, and a pamphlet including the usual postpartum sex counseling will be provided for them ,in addition to receiving routine care , at the end of the study, based on the obtained information, if couples in control group needs counseling, a counseling session will be held for them.</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:
None of the personal information of the samples can be accessed, but non-identifiable data and things like study protocol documentation, data analysis program will be shared.

When:
Year 1402

To whom:
Other researchers

Conditions:
If permission is obtained from the authors of the work

Where to obtain:
Sara Heydari-Contact number: 09361742070
Peyman building-Andrezgo 5-Andrezgo St- Saveh.
Email: mahhaid1371@gmail.com

How to obtain:
The request should be sent via e-mail, and the data file will be sent to them via e-mail within a maximum of one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.7-Peyman building., Andrezgoo 5th .,Andrezgoo St.</address>
        <city>Saveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3918847835</zip>
        <telephone>+98 86 4241 4105</telephone>
        <email>mahhaid1371@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Peyman building ., Andrezgo 5th ., Andrezgo St., Saveh</address>
        <city>Saveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3418847835</zip>
        <telephone>+98 86 4241 4105</telephone>
        <email>mahhaid1371@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparity
Living with a spouse
Have exclusive breastfeeding
Have a  singleton full-term birth (after 38 weeks)
Being in the first six months after delivery
Being accessible within the next two months
Have a healthy child without physical problems or special diseases
Have  smartphone</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of sexual activity with spouse during the postpartum period
Severe marital conflicts and the occurrence of unfortunate events (death of loved ones, accidents, etc.),
Having a history of chronic mental and physical illness (check the records in the file and history)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before the intervention, the  questionnaire link will be sent through the "Whatsapp "application and the people will be coded. In addition to routine postpartum care, the intervention group will receive five counseling sessions through video calls on "Whatsapp" messenger. Sessions include couples and counselors (three people). "My wife" book (skill training in marital and sexual relations) and the textbook of sexual disorders are considered as educational resources. Counseling sessions are held every 5 days, and after the end of each counseling session, a phone call is made in order to explain more about the training and not to forget the exercises within five days until the next counseling session. Videos, images and educational content related to each session will be provided to couples through social messengers.</i_keyword>
      <i_keyword>Control group :the usual postpartum care will be received, and a pamphlet including the usual postpartum sex counseling will be provided for them ,in addition to receiving routine care , at the end of the study, based on the obtained information, if couples in control group needs counseling, a counseling session will be held for them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sextual function score. Timepoint: Before and immediately after the end of the study, one week, one month and two months after the intervention. Method of measurement: Female Sexual function Index FSFI-6,International index of erectile function: (IIEF-5).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The level of sexual distress of couples. Timepoint: Before and immediately after the end of the study, one week, one month and two months after the intervention. Method of measurement: Female Sexual Distress Scale (FSDS_R ).</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-19</approval_date>
        <contact_name>Ethics of Qazvin medical university</contact_name>
        <contact_address>University campus building,Bahonar Blv Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
