<?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>IRCT20190309042976N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-02</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Counseling based on EX-PLISSIT model on Sexual Self-Concept and Marital Satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the Effectiveness of Counceling based on EX-PLISSIT model on Sexual Self-Concept and Marital Satisfaction in Infertile Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38543</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants in this study will be assigned to two groups by block randomization method (blocks of size 4). The blocks are as follows:Test group: A, Control group: B.

1-	AA BB
2-	AB AB
3-	AB BA
4-	BB AA
5-	BA BA
6-	BA AB
After creating the different states of the blocks of size 4, We produce random numbers 1 to 6 using a regular hexagon. This process will be repeated 24 times. For the selection of a random number, a block of size 4 will be selected, accordingly 2 people will be in the test group and 2 people will be in the control group. At each stage of the study, the number of people assigned to the test and control group is the same, Blinding description: In this study, participants were kept blind and after completing the first stage questionnaire, they would be informed which of the test or control groups they were in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual self-concept and marital satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: infertile women receiving counseling. The counseling intervention group was based on the PLISSIT-EX model, during which two one-hour weekly visits were held at Hazrat Maryam Infertility Center. Individual counseling was without the presence of a spouse, and during these sessions, the patient was first told about his or her problems by creating a safe, trustworthy, and non-judgmental environment. The patient was then allowed to talk about his or her marital satisfaction and sexual problems. In the next step, the researcher provided limited information directly related to the client's sexuality and concerns, and provided the patient with information about the anatomy and physiology of the female sexual organ, the stages of the sexual cycle, and sexual function. At the end, the client was offered a specific and problem-solving proposal, and during each step there was feedback to increase self-awareness, and the review process was guided by reviewing, exchanging views and opinions, and discussing patient learning and understanding during counseling. Intervention 2: Control group: Infertile women who completed only the questionnaires in three stages and no advice was given to them until the end of the project. At the end of the project, the control group was asked to hold counseling sessions if they wished, and only two people were willing to hold counseling sessions, which were also consulted.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Consult the supervisor</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arezo Khodaiyan Karim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Moalem</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5346852</zip>
        <telephone>+98 58 3223 0540</telephone>
        <email>a.khodaiyan@mail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezo Khodaiyan Karim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Moalem</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>58463</zip>
        <telephone>+98 58 3223 0540</telephone>
        <email>a.khodaiyan@mail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Couples living together during research (no barriers to the presence of a spouse at home, such as having a job in a city other than the spouse's residence).
Having high school education and more (due to the complexity of the self-concept questionnaire)
At least 6 months and up to 10 years have passed since their infertility was diagnosed
Have no children (primary infertility)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Any severe psychological stress such as an accident or the loss of a loved one over the past 3 months
Underlying medical conditions such as heart disease, gastrointestinal or respiratory disease, epilepsy, high blood pressure, diabetes, rheumatoid arthritis, or depression (self-reported)
Addiction of each couple to drugs and alcohol (based on self-expression)
Known sexual dysfunction, including vaginismus, premature ejaculation (based on self-expression)</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>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: infertile women receiving counseling. The counseling intervention group was based on the PLISSIT-EX model, during which two one-hour weekly visits were held at Hazrat Maryam Infertility Center. Individual counseling was without the presence of a spouse, and during these sessions, the patient was first told about his or her problems by creating a safe, trustworthy, and non-judgmental environment. The patient was then allowed to talk about his or her marital satisfaction and sexual problems. In the next step, the researcher provided limited information directly related to the client's sexuality and concerns, and provided the patient with information about the anatomy and physiology of the female sexual organ, the stages of the sexual cycle, and sexual function. At the end, the client was offered a specific and problem-solving proposal, and during each step there was feedback to increase self-awareness, and the review process was guided by reviewing, exchanging views and opinions, and discussing patient learning and understanding during counseling.</i_keyword>
      <i_keyword>Control group: Infertile women who completed only the questionnaires in three stages and no advice was given to them until the end of the project. At the end of the project, the control group was asked to hold counseling sessions if they wished, and only two people were willing to hold counseling sessions, which were also consulted.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual self-concept score on the Snell questionnaire. Timepoint: Before the start of the intervention, one week later and one month after the start of the intervention. Method of measurement: Snell Persian sexual self-concept questionnaires.</prim_outcome>
      <prim_outcome>Marital Satisfaction Score in Lee Questionnaire. Timepoint: Before the start of the intervention, one week later and one month after the start of the intervention. Method of measurement: Lee's Persian Marital Satisfaction Questionnaire.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-01</approval_date>
        <contact_name>Ethics Committee of Gorgan University of Medical Sciences</contact_name>
        <contact_address>Shast Kola Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
