<?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>IRCT20200308046720N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-08</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of consultation based on mindfulness on health promoting behaviors of adolescents with premenstrual syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of consultation based on mindfulness on health promoting behaviors of adolescents with premenstrual syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46863</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Blinding description: Random selection.</study_design>
      <phase>2</phase>
      <hc_freetext>Health promotion, premenstrual syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:46 Meybod high school girls who meet the criteria for entering the study and their pms were confirmed and randomly selected by completing two consecutive courses of the psst questionnaire one week before menstruation. The present study is a quasi-experimental study that will be conducted in parallel with the previous and subsequent methods.In this study, the intervention group received 8 counseling sessions with a mindfulness approach on a weekly basis for 5.1–2 hours and evaluated the health-promoting behaviors of the intervention group at the beginning of the study, the end of the eighth week, and the twelfth week.In addition to evaluating health-promoting behaviors, their premenstrual syndrome is assessed with a psst questionnaire.Counseling Content: Week 1: Automated Guidance, Week 2: Dealing with Obstacles and More Control Reaction to Daily Events, Week 3: Breathing with Mind Presence, Week 4: Present Present, Week 5: Acceptance and Permission, Week 6: Thoughts are not facts, Week 7: Self-care, Week 8: Using what you have learned. Intervention 2: Control group:  Meybod's 46 high school girls met the criteria for entering the study, and their pms were confirmed and randomly selected by completing two consecutive courses of the psst questionnaire one week before menstruation.The present study is a quasi-experimental study that will be conducted in parallel with the previous and subsequent methods. In this research, the control group does not see any training and after the end of the research, they will receive all the training of the intervention group. Behavioral health promotion behaviors are assessed at the beginning of the study, at the end of the eighth week, and at the twelfth week.In addition to evaluating health-promoting behaviors, their premenstrual syndrome is assessed with a psst questionnaire.</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 I haven't decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farahnaz Moradymahmodabade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Saeedi Street</address>
        <city>Meybod</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8961974360</zip>
        <telephone>+98 35 3232 9473</telephone>
        <email>moradyfarahnaz@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farahnaz Moradymahmodabade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Saeedi Street</address>
        <city>Meybod</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8961974360</zip>
        <telephone>+98 35 3232 9473</telephone>
        <email>moradyfarahnaz@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 1 year has passed since the first menstruation
Regular periods with normal intervals in each period (21-35 days)
High school girls aged 17-15
Moderate to severe premenstrual syndrome (score 19 or higher in the PSST questionnaire)
Satisfaction with participating in the intervention</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>17 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Irregular menstruation
Consumption of hormonal compounds
Having a chronic mental and physical illness
Medication to relieve the symptoms of premenstrual syndrome
Being under any kind of environmental stressful event
Psychotherapy and the use of psychiatric drugs
Single parent families</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:46 Meybod high school girls who meet the criteria for entering the study and their pms were confirmed and randomly selected by completing two consecutive courses of the psst questionnaire one week before menstruation. The present study is a quasi-experimental study that will be conducted in parallel with the previous and subsequent methods.In this study, the intervention group received 8 counseling sessions with a mindfulness approach on a weekly basis for 5.1–2 hours and evaluated the health-promoting behaviors of the intervention group at the beginning of the study, the end of the eighth week, and the twelfth week.In addition to evaluating health-promoting behaviors, their premenstrual syndrome is assessed with a psst questionnaire.Counseling Content: Week 1: Automated Guidance, Week 2: Dealing with Obstacles and More Control Reaction to Daily Events, Week 3: Breathing with Mind Presence, Week 4: Present Present, Week 5: Acceptance and Permission, Week 6: Thoughts are not facts, Week 7: Self-care, Week 8: Using what you have learned</i_keyword>
      <i_keyword>Control group:  Meybod's 46 high school girls met the criteria for entering the study, and their pms were confirmed and randomly selected by completing two consecutive courses of the psst questionnaire one week before menstruation.The present study is a quasi-experimental study that will be conducted in parallel with the previous and subsequent methods. In this research, the control group does not see any training and after the end of the research, they will receive all the training of the intervention group. Behavioral health promotion behaviors are assessed at the beginning of the study, at the end of the eighth week, and at the twelfth week.In addition to evaluating health-promoting behaviors, their premenstrual syndrome is assessed with a psst questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behaviors promoting the health of adolescents with PMS. Timepoint: Intervention before, after and one month later. Method of measurement: Walker Health Promotion Lifestyle Questionnaire.</prim_outcome>
      <prim_outcome>Behaviors promoting the health of adolescents with PMS. Timepoint: Intervention before, after and one month later. Method of measurement: Walker Health Promotion Lifestyle Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Premenstrual Syndrome. Timepoint: Before, after and a month after the intervention. Method of measurement: PSST questionnaire.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-20</approval_date>
        <contact_name>Ethics Committee Yazd University of Medical Sciences</contact_name>
        <contact_address>Saeedi Street Meybod Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
