<?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>IRCT2017082935980N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-27</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>the effect of Emotion-Focused Therapy on premenstrual syndrome.</public_title>
      <acronym></acronym>
      <scientific_title>The study of the effect of Emotion-Focused Therapy on premenstrual syndrome in First year undergraduate students residing in Shaghayegh dormitory’s  Shahrood University of Medical Sciences.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27034</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: So far, in Iran, the study on the effect of Emotion-Focused Therapy on premenstrual syndrome has not been done and this approach has been used only in couple relationships.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Premenstrual syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention in the interventional group:&#13;
 Four sessions of group training in four consecutive weeks will be set up for 90 minutes with lecture, question and answer and group discussions.&#13;
 1. The content of the first session will include providing the necessary information on the study and its objectives, providing the necessary training in the description of the female reproductive system, definition of premenstrual syndrome and its causes.&#13;
 2. At the second session, emotions, emotions and psychological symptoms will be discussed about premenstrual syndrome. &#13;
3. The content of the third session will be stress management, coping with stress, avoiding unnecessary stress and replacing situations and accepting things that can not be changed. &#13;
4. At the fourth session, the assignments will be reviewed and the answers to questions and uncertainties will be discussed in a lecture, group discussion and question and answer. Intervention 2: Interventions in the control group:&#13;
 Four sessions of group training on the topic of genitourinary tract infections in women, will be set up for a period of 90 minutes with lecture, question and answer methods and group discussion.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Payam Azadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Tir square, central building of Shahroud University of Medical Sciences</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>emamian@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh Asghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sharif Health Services Center, Meysam Temar St., Shahid Mostafa Khomeini Boulevard, Imam Town.</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3239 2774</telephone>
        <email>asghari.mid94@yahoo.com</email>
        <affiliation>Shahroud</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>major Inclusion criteria: First year undergraduate students residing in dormitory; Confirmation of premenstrual syndrome by acquiring a PSST questionnaire; Satisfaction to participate in the study; Being Iranian; Being Single; Resident living in dormitory; Normal menstruation at least 4 to 8 cycles in the last 6 months.&#13;
major exclusion criteria: Regular exercise during the 3 months prior to the start of the study and at the time of study (membership in the sports teams of the province and Participate in regular exercise programs at least three times a week or more for at least 30 minutes); Have a specific diet (vegetarianism, raw food, Hydrotherapy). Drug; Herbal medicine and non-pharmacological treatments (relaxation exercises, yoga, acupuncture, medication) to improve premenstrual problems during the 3 months prior to the start of the study; history or affection chronic diseases,asthma, diabetes, hypertension, epilepsy, Migraine, Thyroid disorders, anemia, cardiovascular disease, Respiratory and Renal Diseases, Neuropsychiatry); Incidents of unpleasant (such as the death of one of the first-degree relatives, severe family disputes, and severe family financial problems) during the 3 months prior to the start of the study; Being absent more than one meeting; acquaintance with Life Skills.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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 in the interventional group:&#13;
 Four sessions of group training in four consecutive weeks will be set up for 90 minutes with lecture, question and answer and group discussions.&#13;
 1. The content of the first session will include providing the necessary information on the study and its objectives, providing the necessary training in the description of the female reproductive system, definition of premenstrual syndrome and its causes.&#13;
 2. At the second session, emotions, emotions and psychological symptoms will be discussed about premenstrual syndrome. &#13;
3. The content of the third session will be stress management, coping with stress, avoiding unnecessary stress and replacing situations and accepting things that can not be changed. &#13;
4. At the fourth session, the assignments will be reviewed and the answers to questions and uncertainties will be discussed in a lecture, group discussion and question and answer.</i_keyword>
      <i_keyword>Interventions in the control group:&#13;
 Four sessions of group training on the topic of genitourinary tract infections in women, will be set up for a period of 90 minutes with lecture, question and answer methods and group discussion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determine the mean score PMS in both groups. Timepoint: Before the intervention, immediately after the intervention and 3 months after the intervention. Method of measurement: Screening Scale for Premenstrual Symptoms (PSST).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determine the mean score of general health in both groups. Timepoint: Before the intervention, immediately after the intervention and 3 months after the intervention. Method of measurement: General Health Questionnaire (GHQ).</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>Vice chancellor for research, Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-19</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Central building of Shahroud University of Medical Sciences, 7'th Tir square, Shahroud. Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
