<?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>IRCT138901253706N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-09-21</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The comparison of the effectiveness of acupressure and Iboprofen on primary dysmenorrheal</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effectiveness of acupressure at the sanyinjiao point (sp6) and Iboprofen on primary dysmenorrhea (spasmodic, congestive)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3795</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: To prevent contamination (teaching the technique by subjects in the accupressure groups to the other subjcts), cluster random allocation will be used. If the number of the eligible persons in any group is more than 18, simple randomization will be used to select the subjects.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Primary dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: An expert in acupressure will instruct method of pressure to the participants and will ask them to use this method during dysmenorrhea. Every paricipant should press sp6 point by her thumb for 5 minutes (periods of 6 seconds pressure and 2 seconds rest), until the participant will feel heaviness and numbness around sp6 point. After every 5 minutes the leg will be changed and this procedure will be done on the other leg for 20 minutes (every leg will be pressed two periods of 5 minutes). Intervention 2: Control group: Ibuprofen Tabs (400 mg) every 6 hours if needed.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://www.ncbi.nlm.nih.gov/pubmed/23450186</results_url_link>
      <results_summary> The effect of acupressure at the Sanyinjiao point (SP6) on primary dysmenorrhea in students resident in dormitories of Tabriz&lt;br /&gt;&#13;
Sakineh Mohammad Alizadeh Charandabi*, Maryam Shabani Nashtaei**,&lt;br /&gt;&#13;
Sedigheh Kamali***, Ramin Majlesi****&lt;br /&gt;&#13;
Abstract&lt;br /&gt;&#13;
BACKGROUND: There are two types of primary dysmenorrhea (spasmodic and congestive) which differ from each other in terms of the occurrence time in menstrual cycle, pain quality and other symptoms. The present study aimed to determine the effect of acupressure at the Sanyinjiao point (SP-6) on severity of menstrual symptoms (primary outcome) and the duration of resting time as well as the number of ibuprofen consumption (secondary outcome) in the two types of primary&lt;br /&gt;&#13;
dysmenorrhea.&lt;br /&gt;&#13;
METHODS: This was a clustered randomized controlled trial on 72 eligible students residing in dormitories of public universities of Tabriz. Determining the type of primary dysmenorrhea using a Menstrual Symptoms Questionnaire (MSQ), 36 participants which suffered from each type of dysmenorrhea were enrolled from the four dormitories. The dormitories were randomly divided into intervention and control groups. No intervention was carried out at the first cycle. During the two next cycles, Sanyinjiao point of the subjects in the intervention group was pressed for twenty minutes at the time of pain. The subjects in both groups were allowed to consume ibuprofen, if needed. During these three cycles, the participants recorded and reported menstrual symptoms severity, duration of resting time and the number of the used ibuprofen.&lt;br /&gt;&#13;
RESULTS: The severity of menstrual symptoms and duration of resting time in the 2nd and 3rd cycles were significantly reduced more than control groups for both spasmodic and congestive types of primary dysmenorrhea. In addition, the average numbers of ibuprofen pills taken by both intervention groups was significantly less than the control groups. There was no significant difference between the two intervention groups in terms of any of the outcomes.&lt;br /&gt;&#13;
CONCLUSIONS: Acupressure is effective on lowering the symptoms of dysmenorrhea and duration of resting time almost equally in both spasmodic and congestive types. Therefore, using this method either alone or along with other methods is recommended to treat dysmenorrhea.&lt;br /&gt;&#13;
KEY WORDS: Dysmenorrhea, acupressure, complementary medicine, controlled randomized trial.          </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>Maryam Shabani Nashtaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to Tourism Hotel, Jolfa</address>
        <city>Jolfa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 49 2302 2778</telephone>
        <email>mshabaninashtaei@yahoo.com , maryam.shabani.n@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences, Aras Unit</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Mohammad-Alizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, South Shariati</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1477 2699</telephone>
        <email>alizades@tbzmed.ac.ir , smoalch@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences, Nursing &amp; Midwifery Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Single, age 18-22, Having regular menstrual cycle (mensturation length 3-8 days and length of menstrual cycle 21-35 days) and suffering from dysmenorrhea in previous two years, pain score more than 5 according to visual analogue scale (medium to severe dysmenorrhea), lack of known pelvic disease and known physical and mental diseases, Non consumption of oral contraceptive pills, Lack of pain throughout menstrual cycle or throughout menstrual bleeding, Lack of allergy to NSAIDs, lack of ulcer and inflammatory or skin disease around sp6 point.  Exclusion Criteria: Occurrence of Pelvic disease, pelvic and abdomen operations, high emotional stress (parents' divorce, relative death, etc).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>22 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.4</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: An expert in acupressure will instruct method of pressure to the participants and will ask them to use this method during dysmenorrhea. Every paricipant should press sp6 point by her thumb for 5 minutes (periods of 6 seconds pressure and 2 seconds rest), until the participant will feel heaviness and numbness around sp6 point. After every 5 minutes the leg will be changed and this procedure will be done on the other leg for 20 minutes (every leg will be pressed two periods of 5 minutes).</i_keyword>
      <i_keyword>Control group: Ibuprofen Tabs (400 mg) every 6 hours if needed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptom severity. Timepoint: for three months; first tow days of menstrual cycle in spasmodic dysmenorrhea, two days before menstrual bleeding in congestive dysmenorrhea. Method of measurement: Symptom Severity Scale (SSS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rest lenght. Timepoint: for three months; first tow days of menstural cycle in spasmodic dysmenorrhea, two days before menstural bleeding in congestivedysmenorrhea. Method of measurement: reported rest lenght (hour) by participant.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-10</approval_date>
        <contact_name>Tabriz University of Medical Sciences - Research deputy</contact_name>
        <contact_address>Golgasht street Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
