<?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>IRCT20130812014333N97</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-11</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention based on positive psychology and exercise on depression anxiety and stress on students with premenstrual syndrome</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effect of the educational intervention based on positive psychology and exercise on depression anxiety and stress on students with premenstrual syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32363</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individually Randomization method by random number table via code receipt, Blinding description: The statistical analyst is unaware of the allocation of study groups (experimental and control).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premenstrual Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group will receive 8 training sessions per week for 70 to 90 minutes of positive psychology education. Intervention 2: In the second intervention group, the regular exercise program will be performed three days a week, for 20-30 minutes and 8 weeks, including 5 minutes of warm-up body movements at the beginning of the program, 10-15 minutes soft running with rest intervals and at the end of the time, stretching and relaxing movements  will be performed for 5 minutes to cool the body. Intervention 3: Third intervention group will receive both interventions include sports activities and educational intervention based on positive psychology for eight weeks. Intervention 4: The control group will not receive any intervention.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The main outcomes of the study will be shared.

When:
6 months

To whom:
If requested, results will be made available to other academic researchers

Conditions:
Collected data is confidential and will not be shared with anyone else

Where to obtain:
To receive the documentation, email send for update manager

How to obtain:
In a 45-day period, the documents will be sent e-mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Shahvisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3826 6429</telephone>
        <email>shahvisif@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sosan Heydarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3826 6429</telephone>
        <email>s.heydarpour1394@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Regular menstruation
The length of the menstrual cycle between 22-35 days
The number of menstrual bleeding days between 8-3 days
Grade higher than 18 on premenstrual symptoms questionnaire</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>24 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>A history of ovarian cysts or women's surgery
History of taking or starting antidepressants, relaxing and hormonal medications
The incidence of unfavorable events or the death of loved ones and divorce in the last three months
Premenstrual dysfunction diagnosis</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>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group will receive 8 training sessions per week for 70 to 90 minutes of positive psychology education.</i_keyword>
      <i_keyword>In the second intervention group, the regular exercise program will be performed three days a week, for 20-30 minutes and 8 weeks, including 5 minutes of warm-up body movements at the beginning of the program, 10-15 minutes soft running with rest intervals and at the end of the time, stretching and relaxing movements  will be performed for 5 minutes to cool the body</i_keyword>
      <i_keyword>Third intervention group will receive both interventions include sports activities and educational intervention based on positive psychology for eight weeks.</i_keyword>
      <i_keyword>The control group will not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: The beginning of the study, the end of the study and two months after the end of the study. Method of measurement: Based on the Depression, Anxiety and Stress Scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: The beginning of the study, the end of the study and two months after the end of the study. Method of measurement: Based on the Depression, Anxiety and Stress Scale.</prim_outcome>
      <prim_outcome>Stress. Timepoint: The beginning of the study, the end of the study and two months after the end of the study. Method of measurement: Based on the Depression, Anxiety and Stress Scale.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-12</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti, Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
