<?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>IRCT20230506058105N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-19</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of a couple-oriented counseling program based on empathic communication on the level of perceived communication, marital conflicts and sexual intimacy</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of couple-oriented counseling program based on empathic communication on the level of perceived communication, marital conflicts and sexual intimacy of infertile couples</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69997</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Other design features: The designed study is an educational and counseling type that teaches infertile couples about empathic communication with the EIS (empathy, intimacy, sexual satisfaction) model and the mental health of infertile couples by measuring the level of perceived communication, marital conflicts and It measures their sexual intimacy, Randomization description: Randomization method and description of each method: simple randomization
Randomization Unit: Individual
Randomization tool: the use of sealed envelopes containing cards A and B, which are chosen by a person who does not know the contents of the cards.
The people for whom the A card was selected will be in the intervention group and the people for whom the B card is selected will be in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Perceived communication. Condition 2: marital conflicts. Condition 3: Sexual intimacy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Counseling sessions are held in groups of 6-8 people and weekly for 6 sessions of 45-60 minutes and 2 sessions for each couple for the intervention group. Group meetings will be held only for women and the booklet will be provided to their spouses. And homework will be done in pairs. Two counseling sessions will be held for each couple. Regarding the time of holding private meetings with the couple, coordination will be necessary. The control group together with the control group will answer the question in the pre-test stage (before the intervention), post-test (in the sessions of the last session of the intervention) and in the stage of a two-month intervention. The sessions for the intervention group include: the first session. (Counselor and clients get to know each other and create a good relationship with the couple) - Second session (familiarization with communication skills) - Third session (communal understanding and dealing with couples' duality) - Fourth session (familiarization with problem solving skills) - Fifth session (familiarity) with verbal and relational intimacy) - the sixth session (evaluation). Intervention 2: Control group: People in the control group will complete the couple's perceived communication questionnaire, the sexual intimacy questionnaire, and the couple's marital conflicts questionnaire once before the intervention sessions, once at the end of the interventions, and again in the two-month follow-up. And they will not receive any intervention and at the end of the intervention they will receive an educational package.</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:
It is only part of the sharing

When:
5 months after printing the results

To whom:
researchers

Conditions:
research works

Where to obtain:
Email

How to obtain:
send an email(zahraayyari076@gmail.com)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Ayyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 3, Ten Meters of the sixth west Ave, Tavanir Blvd</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5156966874</zip>
        <telephone>+98 41 3328 5135</telephone>
        <email>zahraayyari076@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Ayyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 3, Ten meters of the sixth west Ave, Northern Tawanir Blvd</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5156966874</zip>
        <telephone>+98 41 3328 5135</telephone>
        <email>zahraayyari076@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All people who have Iranian nationality
All residents of Urmia city
All infertile couples in the age range of 20-45 years
Being familiar with the Persian language
Couples with primary infertility
Couples who have been diagnosed with infertility in both couples
Having minimum literacy in both couples
Attendance of both couples in intervention sessions</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participating in similar studies at the same time
Existence of psychiatric disorder in couples
Drug use by couples</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Counseling sessions are held in groups of 6-8 people and weekly for 6 sessions of 45-60 minutes and 2 sessions for each couple for the intervention group. Group meetings will be held only for women and the booklet will be provided to their spouses. And homework will be done in pairs. Two counseling sessions will be held for each couple. Regarding the time of holding private meetings with the couple, coordination will be necessary. The control group together with the control group will answer the question in the pre-test stage (before the intervention), post-test (in the sessions of the last session of the intervention) and in the stage of a two-month intervention. The sessions for the intervention group include: the first session. (Counselor and clients get to know each other and create a good relationship with the couple) - Second session (familiarization with communication skills) - Third session (communal understanding and dealing with couples' duality) - Fourth session (familiarization with problem solving skills) - Fifth session (familiarity) with verbal and relational intimacy) - the sixth session (evaluation)</i_keyword>
      <i_keyword>Control group: People in the control group will complete the couple's perceived communication questionnaire, the sexual intimacy questionnaire, and the couple's marital conflicts questionnaire once before the intervention sessions, once at the end of the interventions, and again in the two-month follow-up. And they will not receive any intervention and at the end of the intervention they will receive an educational package.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived communication score in couples' self-perceived communication questionnaire. Timepoint: Before the beginning of the intervention, at the end of the intervention and one month after the end of the intervention. Method of measurement: Couples' self-perceived communication questionnaire(SCCR).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Marital conflicts score. Timepoint: Before the start of the intervention, at the end of the intervention and one month after the end of the intervention. Method of measurement: Marital conflicts questionnaire (MCQ).</sec_outcome>
      <sec_outcome>ُُSexual intimacy. Timepoint: Before the start of the intervention, at the end of the intervention and one month after the end of the intervention. Method of measurement: Sexual intimacy questionnaire.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-01</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urgency Ave, Resalat Blvd Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
