<?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>IRCT20200122046228N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-24</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Effects of sexual counseling based on the PLISSIT model on the sexual quality of life, sexual function Index and sexual satisfaction of postpartum women</public_title>
      <acronym></acronym>
      <scientific_title>Effects of sexual counseling based on the PLISSIT (Permission, Limited Information, Specific Suggestions, Intensive Therapy) model on the sexual quality of life, sexual function Index and sexual satisfaction of postpartum women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69562</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization will be done using a block of six, Randomization description: Random assignment to one of the two study groups the block randomization method with a block size of 6 will be used. Then, according to the block randomization protocol (Randomization list using the statistical program in R software environment version 3.6.1), the participants will be divided into one of the two groups: PLISSIT, and the control group; They will be allocated a ratio of 1:1 so that the researcher cannot predict which group the next person will be placed in the intervention or control groups in each center. The participants are allocated to two groups of 36 people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Female Sexual dysfunction after childbirth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In the intervention group, psychosexual counseling will be done virtually in the sky room based on the PLLISIT model individually during 4 sessions of 25 to 30 minutes once a week for consecutive weeks depending on the needs of the research subjects. Intervention 2: Control group: The control group does not receive any intervention, and they will be under routine care according to the integrated care of pregnancy and postpartum, and finally, after the end of the intervention and evaluations, due to ethical considerations, the contents of the consultation will be provided to the control group in the form of a compact CD file.</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 Considering that the performance and satisfaction of sexual relations have privacy, I prefer that the data file not be published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Nasiri Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz Ave,</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3219 0597</telephone>
        <email>nasiri_fa@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Nasiri Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3219 0597</telephone>
        <email>nasiri_fa@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Postpartum women between 18 and 45 years old who had a vaginal delivery or cesarean delivery two months to one year before.
Women who can at least read and write.
Have consistent sexual activity with their husband for at least the last four weeks.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Severe psychiatric disorders, Psychotic disorder and bipolar disorder
History of addiction of the mother or her husband
Chronic medical diseases that affect sexual issues
Using drugs that cause sexual dysfunction such as barbiturates, benzodiazepines, antidepressants, antihypertensive
Experiencing a stressful event in the last three months (death or acute illness of a close relative, major change in living situation such as the imprisonment of the husband and..)
Undesirable consequences of a newborn such as premature birth, birth with one of the known abnormalities or infant death,</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction not due to a substance or known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In the intervention group, psychosexual counseling will be done virtually in the sky room based on the PLLISIT model individually during 4 sessions of 25 to 30 minutes once a week for consecutive weeks depending on the needs of the research subjects.</i_keyword>
      <i_keyword>Control group: The control group does not receive any intervention, and they will be under routine care according to the integrated care of pregnancy and postpartum, and finally, after the end of the intervention and evaluations, due to ethical considerations, the contents of the consultation will be provided to the control group in the form of a compact CD file.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum Sexual Quality of Life. Timepoint: Before the start of the intervention and two months after the end of the intervention. Method of measurement: To evaluate postpartum sexual quality of  life, the 22-question scale of PSQOL-F, Rahmani et al. will be used.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Female Sexual Function Index. Timepoint: Before the start of the intervention and two months after the end of the intervention. Method of measurement: The 19-question scale of the Female Sexual Performance Index (FSFI) is used to evaluate sexual performance.</sec_outcome>
      <sec_outcome>Sexual satisfaction. Timepoint: Before the start of the intervention and two months after the end of the intervention. Method of measurement: Larson's 25-question sexual satisfaction scale will be used to evaluate sexual satisfaction.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-17</approval_date>
        <contact_name>Research Ethics Committee of Health Research Institute, Babol University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, Babol University of Medical Sciences, Ganj Afrooz Ave. Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
