<?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>IRCT20220625055268N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-24</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The efficacy of mindfulness-based stress reduction on psychological symptoms and quality of life in students with premenstrual syndrome in 1401</public_title>
      <acronym>pms: premenstrual syndrome</acronym>
      <scientific_title>The efficacy of mindfulness-based stress reduction on psychological symptoms and quality of life in students with premenstrual syndrome in 1401</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64405</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premenstrual syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Application of mindfulness training program to reduce mental and physical symptoms in dormitory girls diagnosed with premenstrual syndrome in 8 sessions of 90 minutes which are held once a week in groups. Each session begins with an exercise and is followed by a discussion. Continues with practice and ends with homework. This treatment is in accordance with the treatment protocol of Kabat Zain 2013. The relevant questionnaires are completed by the participants before and after the intervention (2 months later). Intervention 2: The control group will be trained in emotion regulation skills during the waiting sessions. In order to compare the results of the intervention, the relevant questionnaires before and after the intervention (2 months) are also completed by the control 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The work is interventional, personal and confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vajihe Rouhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan, Amir Al-Momenin St., 42 Zolfaqar Alley, Aseman Complex</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973446</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>rouhivajihe@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shafighe Yousefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan, Natanz St., Sajjadieh Alley</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973446</zip>
        <telephone>+98 31 5520 3112</telephone>
        <email>sh.yusefi2012@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not receiving psychotherapy for at least the last 3 months
Diagnosis of pre-pregnancy symptoms by a questionnaire or certification by a specialist
Do not currently be under any mental illness treatment
Be single</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of substance abuse and stimulants
Unwillingness to participate in research</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Application of mindfulness training program to reduce mental and physical symptoms in dormitory girls diagnosed with premenstrual syndrome in 8 sessions of 90 minutes which are held once a week in groups. Each session begins with an exercise and is followed by a discussion. Continues with practice and ends with homework. This treatment is in accordance with the treatment protocol of Kabat Zain 2013. The relevant questionnaires are completed by the participants before and after the intervention (2 months later).</i_keyword>
      <i_keyword>The control group will be trained in emotion regulation skills during the waiting sessions. In order to compare the results of the intervention, the relevant questionnaires before and after the intervention (2 months) are also completed by the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Mindfulness-based stress reduction training program is 8 sessions of 90 minutes that will be done once a week in groups. Method of measurement: Premenstrual Symptoms Scale Questionnaire, DASS-21 Questionnaire (for measuring anxiety, stress and depression), IRQ Irritability Questionnaire, Bass and Perry Aggression Questionnaire and SF-36 Quality of Life 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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-08</approval_date>
        <contact_name>Medical Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Kashan, km 3, Ravand Road, Pezeshk Blvd., School of Medicine Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
