<?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>IRCT20200117046157N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-04</date_registration>
      <primary_sponsor>Hakim Sabzevari University</primary_sponsor>
      <public_title>The effectiveness of emotion-focused therapy (EFT) on pain perception, Self-Compassion, sexual function and Couple Burnout</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of emotion-focused therapy (EFT) on pain perception, Self-Compassion, sexual function and Couple Burnout in female with premenstrual syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45212</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: En The allocation method will be simple random. Hiding the assignment using a computer is that the computer creates random numbers between zero and one. If the random number is less than 0/5, the individual will be assigned to the test group, and if the random number is greater than 0/5, the individual will be entered into the control group. In this process, people who enter the study list will not be aware of how the treatment is allocated before the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>premenstrual syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Women with premenstrual syndrome will undergo the intervention of the emotion-focused therapy group on a weekly basis for 10 sessions of 90 minutes of the Greenberg and Goldman (2019) emotion-focused treatment protocol. The summary of the content of each session is as follows: 1) Evaluate and create continuityassessment of expectations and concerns of women with pms. conceptualization of the problem and presentation of therapy logic and familiarity with general therapy rules. 2) identify the cycle of negative interactions and determine overall aims, creating a therapeutic agreement. 3) Strengthen continuity and analyze and change emotions. 4) Accepting emotions and identifying attachment needs, strengthening the interaction of group membersdiscover new solutions to old problems. 5) Accepting emotions and identifying attachment needs, strengthening group member interaction, discovering new solutions to old problems. 6) Creating new interactive patterns of emotion acquisitionIntimate engagement of clients with their couples, acceptance of new situations . 7) increasing the identification of attachment needs, facilitating the expression of needs and desires in sexualneeds using the technique of tracking and reflecting . 8) Focus on yourself, not the other person, more compassion for yourself, a framework for re-establishing sexual relation, deepening the couples sexual conflicts. 9) Orienting and Designing Interactions between Couples Replacing the Positive Interaction Cycle with the Negative Cycle. 10) Strengthening new situations and responses, supporting constructive interactive patterns, closing sessions. Intervention 2: Control group: : This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two training sessions on psychological skills will be provided for this group.</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 No More Information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Ghodsi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani street</address>
        <city>Neyshabur</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9316735555</zip>
        <telephone>+98 51 4224 1090</telephone>
        <email>mghodsi290@gmail.com</email>
        <affiliation>Education</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Shareh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tovhid Town Street</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617666666</zip>
        <telephone>+98 51 4441 9050</telephone>
        <email>hsharreh@yahoo.com.au</email>
        <affiliation>دانشگاه حکیم سبزواری</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least one year has passed
At least 190 on the PMS
Having at least a high school diploma
Deliberate signing of a written consent to participate in the research</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>DSM-V Axis I and II disorders
Psychological and counseling services for marital issues in the last 3 months
Psychiatric and psychotropic medication use 3 months before the first session
The apparent risk of suicide right now</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Premenstrual tension syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Women with premenstrual syndrome will undergo the intervention of the emotion-focused therapy group on a weekly basis for 10 sessions of 90 minutes of the Greenberg and Goldman (2019) emotion-focused treatment protocol. The summary of the content of each session is as follows: 1) Evaluate and create continuityassessment of expectations and concerns of women with pms. conceptualization of the problem and presentation of therapy logic and familiarity with general therapy rules. 2) identify the cycle of negative interactions and determine overall aims, creating a therapeutic agreement. 3) Strengthen continuity and analyze and change emotions. 4) Accepting emotions and identifying attachment needs, strengthening the interaction of group membersdiscover new solutions to old problems. 5) Accepting emotions and identifying attachment needs, strengthening group member interaction, discovering new solutions to old problems. 6) Creating new interactive patterns of emotion acquisitionIntimate engagement of clients with their couples, acceptance of new situations . 7) increasing the identification of attachment needs, facilitating the expression of needs and desires in sexualneeds using the technique of tracking and reflecting . 8) Focus on yourself, not the other person, more compassion for yourself, a framework for re-establishing sexual relation, deepening the couples sexual conflicts. 9) Orienting and Designing Interactions between Couples Replacing the Positive Interaction Cycle with the Negative Cycle. 10) Strengthening new situations and responses, supporting constructive interactive patterns, closing sessions.</i_keyword>
      <i_keyword>Control group: : This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two training sessions on psychological skills will be provided for this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain perception. Timepoint: Before the intervention - 30 day After the intervention. Method of measurement: McGill Pain Questionnaire (1997).</prim_outcome>
      <prim_outcome>Self-Compassion. Timepoint: Before the intervention - 30 day After the intervention. Method of measurement: Self-Compassion Questionnaire Neff (2003).</prim_outcome>
      <prim_outcome>Sexual function. Timepoint: Before the intervention - 30 day After the intervention. Method of measurement: sexual function Questionnaire (2000).</prim_outcome>
      <prim_outcome>Couple Burnout. Timepoint: Before the intervention - 30 day After the intervention. Method of measurement: Couple Burnout Questionnaire (2013).</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>Hakim Sabzevari University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-21</approval_date>
        <contact_name>Ethic Committee of Hakim Sabzevari University</contact_name>
        <contact_address>Tovhid Town ,Hakim Sabzevari University Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
