<?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>IRCT138811103226N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-08-07</date_registration>
      <primary_sponsor>The  Intrnational Branch of Medical Science &amp; Health medicine Shahid Beheshti University</primary_sponsor>
      <public_title>The effect of reflexology on premenstrual syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology on premenstrual syndrome among students in the dormitory of jahrom university 1390</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3288</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1</phase>
      <hc_freetext>Premenstrual Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Foot reflexology for 15 minutes on each leg (total 30 minutes) once a day, 10-5 days prior to the time period (monthly bleeding cycle) is, and it is before the onset of symptoms, and the time period be continued (total 10-5 days (. Intervention 2: In the control group (without doing foot reflexology techniques) in those days, ie 5-10 days before menstruation and gentle massage to the feet may be ineffective.</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>Sareh Abdollahifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr niayesh avenue,Nursing &amp; Midwifery college of Shahid Beheshti University of Medical Sciences,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7413934358</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>sareh_abdollahyfard@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences, International-Branch, Iran.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sareh Abdollahifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr-niayesh avenue,Shahid Beheshti University of Medical Sciences, International,nursing &amp;midwifery college,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7413934358</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>sareh_abdollahyfard@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences, International-Branch, Iran.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Iranian race; 18 – 35 year age; normal BMI (19.8 – 26); not addicted to drugs, cigarette and alcohol; regular menstruation (Period between 21 – 35 days); gained score 0 – 9 in Depression Test. By virtue of their own statements they should not have known mental disease such as bipolar and personality disorders, drugs misuse and other mental diseases and depression. Also they should have the syndrome according to the table registering daily signs for two months. They should not use vitamins ( B6, E , sulfate zinc , multivitamin ), contraceptives , medroxyprogesterone, diderogestrone, spironolactone , fluexetine , alperazolam , calcium , anticonvulsive , antidepressive  and herbal  medications in recent three  months or any drugs influencing on the premenstrual syndrome( PMS). They should not have had any deplorable event such as near relatives’ death or surgical operation in recent six months.&#13;
Exclusion criteria: known physical disease; suffering from cardiac diseases; coagulation disorders; deep vein thrombosis; vein phlebitis, infection; feet burn or wound and severe infections; diabetes; heartbeat regulation apparatus and varicose vein and If the patients do not cooperate.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Foot reflexology for 15 minutes on each leg (total 30 minutes) once a day, 10-5 days prior to the time period (monthly bleeding cycle) is, and it is before the onset of symptoms, and the time period be continued (total 10-5 days (</i_keyword>
      <i_keyword>In the control group (without doing foot reflexology techniques) in those days, ie 5-10 days before menstruation and gentle massage to the feet may be ineffective.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Foot Reflexology. Timepoint: 5-10 days before mensturation period. Method of measurement: Check List.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Prementrual Syndrome. Timepoint: Prementrual Syndromeforms have been completed by sampel of this study for 2 months. Method of measurement: Prementrual Syndrome Questinnare daily,DSM4.</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>The  Intrnational Branch of Medical Science &amp; Health medicine Shahid Beheshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-11-29</approval_date>
        <contact_name>The International Branch of Shahid Beheshti university of medical sciences &amp;  health sciences</contact_name>
        <contact_address>Shahid Abbaspoor avenue, Tavanir avenue,  nabshe pol hemmat, the international branch of shahid beheshti university of medical sciences &amp;  health sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
