<?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>IRCT20200624047911N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-05</date_registration>
      <primary_sponsor>Sirjan School of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of two methods of acupressure and massage with ice on huko point on pain intensity</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two methods of acupressure and massage with ice on hoku point on pain intensity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49222</url>
      <study_type>observational</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this pilot study using the method of randomization permutation blocks, 48 ​​samples are randomly assigned in three equal groups. For this purpose, 8 blocks of 6 will be used.
Randomization unit: individual
Randomization tool: Random number table, Blinding description: This study is an interventional study and a randomized clinical trial. This study is a single-blind study in the control group of a plastic ball that is exactly the same ice ball used in the intervention group but at a point close to the point Hoku (outside the main place) massage was applied.</study_design>
      <phase>N/A</phase>
      <hc_freetext>dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Ice therapy at Hoku point. Intervention 2: Intervention group: Massage on the hoku point. Intervention 3: Control group: Ice therapy near Hoku point.</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:
All data can be used after unidentifying individuals.

When:
The access period is 6 months after the publication of the article.

To whom:
Only researchers

Conditions:
Similar to the present study

Where to obtain:
Researcher by contact or email

How to obtain:
Write a request via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naimeh Pourramezani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No165, Gole Gohar Town,Malek e Ashtar Blvd, Sirjan, Kerman, Iran</address>
        <city>Sirjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7817843153</zip>
        <telephone>+98 34 4225 0449</telephone>
        <email>npourramezani@yahoo.com</email>
        <affiliation>The University of Sirjan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naimeh Pourramezani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No165, Gole Gohar Town, Malek e Ashtar Blvd, Sirjan, Kerman, Iran</address>
        <city>Sirjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7817843153</zip>
        <telephone>+98 34 4225 0449</telephone>
        <email>npourramezani@yahoo.com</email>
        <affiliation>The University of Sirjan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Single
Experience painful menstruation in previous cycles
Age between 18-28 years
Regular menstrual cycle
Lack of diseases such as hormonal disorders, heart disease, thyroid, diabetes, asthma, kidney disease
History of medication such as corticosteroids, painkillers, contraceptives
Willingness to cooperate
No history of polycystic ovary disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>28 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Less than 6 months before menarche (first menstruation in women)
The patient has cognitive impairment or mental illness
History of coagulation disorders.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain and other conditions associated with female genital organs and menstrual cycle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Ice therapy at Hoku point</i_keyword>
      <i_keyword>Intervention group: Massage on the hoku point</i_keyword>
      <i_keyword>Control group: Ice therapy near Hoku point</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of menstrual pain is measured on a VAS scale. Timepoint: Half an hour before the intervention, during the intervention, half an hour after the 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>Sirjan School of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-13</approval_date>
        <contact_name>Ethics committee of Sirjan University of Medical Sciences</contact_name>
        <contact_address>Ebne Sina Street, Sirjan City, Kerman,Iran Sirjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
