<?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>IRCT20210919052516N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-15</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cognitive-behavioral  group counseling on reproductive health and sexual satisfaction  in women with endometriosis</public_title>
      <acronym>endometriosis</acronym>
      <scientific_title>The effect of cognitive-behavioral  group counseling on reproductive health and sexual satisfaction  in women with endometriosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58904</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, the permutation block method is used to generate a sequence of random allocation of individuals to the study groups. Random allocation sequence of individuals is done using random allocation software and block size two. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied. In this study, there are two blocks, AB and BA. One of the blocks is selected at random. If the first block, AB, is selected, the first person is assigned to group A and the second person to group B. And this process continues until all the samples are assigned. The characteristic of this method is that the two study groups will have equal numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Endometriosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The clinical trial study has a pre-test, post-test and control group with the research community of women with endometriosis. To participate in the research, first the control group and then the intervention group are invited. The required information will be collected using available qualified sampling. In both intervention and control groups, after providing the necessary explanations about the objectives of the research, observing the independence of individuals to participate in the research and the confidentiality of information, participants are asked to complete the informed consent form and then take a sample from them. Be. Patients aged 15-49 years in the intervention group participate in 7 group counseling sessions and each session for 90-60 minutes with 6 to 8 people, the first and seventh sessions and a month later, in person and the rest of the sessions will be held virtually. . Women in the same group will be in the same group in the first counseling session and in the next sessions. Intervention 2: Control group: They receive routine care at a medical center. In addition, they complete the questionnaires before, immediately and one month later.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Erfanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn sina St, Nursing and Midwifery University</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91388-13944</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>ErfanianF@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Nikseresht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn sina St, mashhad university of medical sciences</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91388-13944</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>Niksereshtcm982@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Written informed consent to participate in the research
Women of childbearing age (15-49 years)
Being Iranian and living in Mashhad
Have a minimum literacy
Getting married and cohabiting
Absence of chronic psychiatric disorders and problems in wife and her husband (self-declaration)
lack of known chronic diseases in wife and husband
Having sex
Diagnosis of endometriosis based on history, physical examination and clinical imaging by a physician
No accidents during the last 6 months
Failure to attend training or cognitive-behavioral counseling classes in the previous 6 months
no addiction and alcohol in wife and husband
No depression, stress or severe anxiety in a woman and her husband according to the DASS-21 scale
Ability to use the Internet and cyberspace if the intervention is done virtually
Failure of the person and his wife to get diseases that affect sexual function
absence of menopause
No history of pelvic surgery
Be the only wife of her husband</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not participating in counseling sessions for more than two sessions and not wanting to continue the intervention
Incomplete completion of the questionnaire (answering less than 10% of the questionnaire)
Incidence of accidents during the study
Receive another training-counseling program during the intervention period.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis, unspecified</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: The clinical trial study has a pre-test, post-test and control group with the research community of women with endometriosis. To participate in the research, first the control group and then the intervention group are invited. The required information will be collected using available qualified sampling. In both intervention and control groups, after providing the necessary explanations about the objectives of the research, observing the independence of individuals to participate in the research and the confidentiality of information, participants are asked to complete the informed consent form and then take a sample from them. Be. Patients aged 15-49 years in the intervention group participate in 7 group counseling sessions and each session for 90-60 minutes with 6 to 8 people, the first and seventh sessions and a month later, in person and the rest of the sessions will be held virtually. . Women in the same group will be in the same group in the first counseling session and in the next sessions</i_keyword>
      <i_keyword>Control group: They receive routine care at a medical center. In addition, they complete the questionnaires before, immediately and one month later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reproductive health. Timepoint: Before and immediately one month after the intervention. Method of measurement: Endometriosis Reproductive Health Questionnaire (ERHQ).</prim_outcome>
      <prim_outcome>Sexual satisfaction. Timepoint: Before and immediately one month after the intervention. Method of measurement: Women's Sexual Satisfaction Scale Questionnaire sssw.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Social support. Timepoint: Before and immediately one month after the intervention. Method of measurement: Standard social support questionnaire.</sec_outcome>
      <sec_outcome>Stress - Anxiety - Depression. Timepoint: Before and immediately one month after the intervention. Method of measurement: Stress-Anxiety-Depression Inventory DASS-21.</sec_outcome>
      <sec_outcome>Intensity of pain. Timepoint: Before and immediately one month after the intervention. Method of measurement: Severity of pain mediated by VAS criteria.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-25</approval_date>
        <contact_name>ethics committee of mashhad university of medical sciences</contact_name>
        <contact_address>Ibn sina St, mashhad mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
