<?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>IRCT20180329039156N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-01</date_registration>
      <primary_sponsor>Zabol University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of ice massage on the Huko point and SP6 on the severity of primary dysmenorrhea of students</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of ice massage on the Huko point (LI4) and SP6 on the severity of primary dysmenorrhea of students in two intervention groups and one control group</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30320</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sampling method is stratified random then students are classified into three groups by block random allocation method, Blinding description: Participants: That is, patients are aware of being involved in the study, but not aware of which group they are in at the time of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Primary dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: : Ice massage (2 cm in diameter inside a plastic bag) was performed on Huko spot in a rotary manner daily for 20 minutes until the onset of primary dysmenorrhea. Intervention 2: Intervention group: Ice massage (2 cm in diameter inside the plastic bag) was performed on spatial 6 in a rotary manner daily for 20 minutes and until the onset of primary dysmenorrhea. Intervention 3: Control group: In the control group, ice massage (2 cm in diameter inside the plastic bag) was performed on an inapplicable spot (except Huko and SP6 ) daily for 20 minutes and until the onset of primary dysmenorrhea.</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:
Some part of data

When:
Start of access to data from six months after publishing the paper.

To whom:
Universities.

Conditions:
for more analysis only for some parts.

Where to obtain:
PI Email: shahdadi@zbmu.ac.ir.

How to obtain:
Send email to PI in Email: shahdadi@zbmu.ac.ir.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hosien Shahdadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rajaei Ave, Zabol University of Medical Sciences, Zabol, Iran</address>
        <city>Zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861663335</zip>
        <telephone>+98 54 3222 5402</telephone>
        <email>shahdadi@zbmu.ac.ir</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosien Shahdadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rajaei Ave, Zabol University of Medical Sciences, Zabol, Iran</address>
        <city>Zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861663335</zip>
        <telephone>+98 54 3222 5402</telephone>
        <email>shahdadi@zbmu.ac.ir</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>painful menstrual periods in most menstrual cycles over the past year
Pain score of more than 4 based on visual pain assessment scale
aged 18 to 28 years,
having regular menstruation (Duration of 3 to 7 days and two-twelve days from 21 to 35 days)
No history of uterine and pelvic disorders
no use of oral contraceptive pills
o history of abdominal or pelvic surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>28 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>smoking in the last six months
exercise professionally in the last six months
the presence of severe stressors in the last six months
Deaths of first-class family members
parental divorce
non-occurrence of menstruation
consumption of more than two dwellings during the study
using hot and cold therapy
taking herbal drugs to reduce menstrual pain
using massage techniques except of the accepted technique of study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary dysmenorrhea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: : Ice massage (2 cm in diameter inside a plastic bag) was performed on Huko spot in a rotary manner daily for 20 minutes until the onset of primary dysmenorrhea.</i_keyword>
      <i_keyword>Intervention group: Ice massage (2 cm in diameter inside the plastic bag) was performed on spatial 6 in a rotary manner daily for 20 minutes and until the onset of primary dysmenorrhea.</i_keyword>
      <i_keyword>Control group: In the control group, ice massage (2 cm in diameter inside the plastic bag) was performed on an inapplicable spot (except Huko and SP6 ) daily for 20 minutes and until the onset of primary dysmenorrhea.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary dysmenorrhoea. Timepoint: Before intervention, After intervention. Method of measurement: VAS.</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>Zabol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-22</approval_date>
        <contact_name>Ethics committee of Zabol University of Medical Sciences</contact_name>
        <contact_address>Rajaei Ave, Zabol University of Medical Sciences, Zabol, Iran Zabol Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
