<?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>IRCT201201308869N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-13</date_registration>
      <primary_sponsor>Vice chancellor for research, Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of acupressure on dysmenorrhea</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of acupressure on third liver Point (liv.3) and sixth spleen point (SP.6) on pain intensity for patients with primary dysmenorrhea</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9341</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, the research unit is not aware of effectiveness or ineffectiveness of pressure point. Also data analyzer is not aware of intervention and control groups. According to pain scale, blocking randomized allocation will be used to divide the sample study into intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Primary dysmenorrhoea.</hc_freetext>
      <i_freetext>Intervention 1: Pressure on sp.6 acupressure point. The pressure is applied on both feet alternately as 2 minutes in the pressure point rotating clockwise and 2 minutes rest. Pressure will be applied two times on each leg and a total of four times (a total of 16 minutes). Each time pressure will be stopped with feeling De Chi (i.e. Feeling of tingling, heat, cold, creep) and will be applied on another foot after 2 minutes. Intervention 2: Pressure on Liv.3 acupressure point. The pressure is applied on both feet alternately as 2 minutes in the pressure point rotating clockwise and 2 minutes rest. Pressure will be applied two times on each leg and a total of four times (a total of 16 minutes). Each time pressure will be stopped with feeling De Chi (i.e. Feeling of tingling, heat, cold, creep) and will be applied on another foot after 2 minutes. Intervention 3: Pressure on placebo point. The pressure is applied on both feet alternately as 2 minutes in the pressure point rotating clockwise and 2 minutes rest. Pressure will be applied two times on each leg and a total of four times (a total of 16 minutes). Each time pressure will be stopped with feeling De Chi (i.e. Feeling of tingling, heat, cold, creep) and will be applied on another foot after 2 minutes.</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>Mahboobeh Kafaei Atrian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th km of Ghotbe Ravandi  Blvd., Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 36 1555 0021</telephone>
        <email>kafaei_m@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboobeh Kafaei Atrian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th km of Ghotbe Ravandi  Blvd., Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715981151</zip>
        <telephone>+98 36 1555 0021</telephone>
        <email>kafaei_m@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Being a student at the dormitory, being single, regularity of menses, start of Pain with the onset of menstrual bleeding, duration of bleeding between 3-8 days and Menstrual intervals of 21-35 days, pain with a score of at least 4 of 10 according to the V.A.S. criteria in most menstrual cycles, lack of pain throughout the all times of menstrual cycle or bleeding, lack of anemia, high blood pressure, Psychiatric disorders especially depression (19 points or more, according to the beck-21 criteria for depression), lack of any known disease of genital tract, secondary dysmenorrhea, no history of abdominal or pelvic surgery, not using tobacco (cigarettes, hookah and drugs) and alcohol, disorders of speech and hearing, mental, heart and renal disorders, respiratory disease, diabetes, asthma, hypothyroidism or hyperthyroidism, severe psychological stress in the past 6 months (e.g., family death, surgery, marriage, separation of parents), lack of voluntary weight loss, absence of any problems in the pressure point such as fractures, ulcers, varicose veins, skin disease or inflammation, specific dietary regimen such as vegetarianism, eating raw, high salt or carbohydrates intake. Exclusion criteria:  Use of heat, oral contraceptives or drugs that can affect on ovulation cycle, non steroidal anti-inflammatory, analgesic, Prostaglandins synthesis inhibitors for 4 hours before till 4 hours after applying pressure, not continue to cooperate until the end of the study (3 cycles).</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N-94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary dysmenorrhoea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Pressure on sp.6 acupressure point. The pressure is applied on both feet alternately as 2 minutes in the pressure point rotating clockwise and 2 minutes rest. Pressure will be applied two times on each leg and a total of four times (a total of 16 minutes). Each time pressure will be stopped with feeling De Chi (i.e. Feeling of tingling, heat, cold, creep) and will be applied on another foot after 2 minutes</i_keyword>
      <i_keyword>Pressure on Liv.3 acupressure point. The pressure is applied on both feet alternately as 2 minutes in the pressure point rotating clockwise and 2 minutes rest. Pressure will be applied two times on each leg and a total of four times (a total of 16 minutes). Each time pressure will be stopped with feeling De Chi (i.e. Feeling of tingling, heat, cold, creep) and will be applied on another foot after 2 minutes.</i_keyword>
      <i_keyword>Pressure on placebo point. The pressure is applied on both feet alternately as 2 minutes in the pressure point rotating clockwise and 2 minutes rest. Pressure will be applied two times on each leg and a total of four times (a total of 16 minutes). Each time pressure will be stopped with feeling De Chi (i.e. Feeling of tingling, heat, cold, creep) and will be applied on another foot after 2 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Pain intensity  in the first cycle at the onset of bleeding and half, one, two and three hours after the onset of bleeding. Pain intensity  in the second cycle at the onset of bleeding and half, one, two and three hours after the onset of  bleeding. Pain intensity  in the third cycle at the onset of bleeding and half, one, two and three hours after the onset of  bleeding. Method of measurement: Visual analog scale of pain intensity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Before intervention (first cycle) and after intervention (third cycle). Method of measurement: Quality of life questionnaire (WHOQOL-BREF-26).</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, Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-18</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Science</contact_name>
        <contact_address>5th of Qotb-e Ravandi Blvd., Kashan University of Medical Science Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
