<?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>IRCT20191218045790N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-25</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Taping Therapy in Primary Dysmenorrhea and Premenstrual Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Taping Therapy in Primary Dysmenorrhea (PD) and Premenstrual Syndrome (PMS) in female students of Sardasht universities in 2018-2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44784</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the first stage, out of 393 female students of Sardasht universities, we will determine eligible people to participate in the study based on the entry and exit criteria. The goal of the study and the probability of being assigned to intervention or control group will be explained to eligible participants in the study. If someone wishes to participate in the study, a written consent will be obtained consciously and based on the output of the following software, from the first to fiftieth people who have tended to participate in the study will be assigned to intervention and control groups by method of random blocking of 4. Eligible individuals will be assigned to control and intervention groups in 13 blocks of 4 people, Blinding description: The participants will be told that they have been chosen in order to examine the effect of taping therapy on the severity of primary dysmenorrhea and premestrual syndrome. they will be divided into two random groups but without them noticing it. the intervention group will be provided with the real tape, but the control group will be provided with the similar tape without having real impact.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dysmenorrhea, premenstrual syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Keynesian tape is a waterproof tape without chemical adhesive. The 3NS TEX brand, made in Korea, measures 5 cm by 5 m. It is installed by a researcher for two menstrual cycles from 5 days before menstruation, after 5 days it is removed by the person and after 24 hours of skin respiration, Re-installed by the researcher and left on the site for another 5 days. In total, the tape is installed on the pain area for 10 days. Intervention 2: Control group:  The actions taken for the intervention group are done exactly for the comparison group without real tape.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soheila Rabipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nazlou, Urmia University of Medical Sciences, School of Nursing and Midwifery</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8202254554</zip>
        <telephone>+98 44 3275 5001</telephone>
        <email>Soheila80@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyran Khezri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mellat</address>
        <city>Sardasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2333565984</zip>
        <telephone>+98 44 4433 5574</telephone>
        <email>seyran.khezri.m@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age range 18-25
single
Regular menstrual cycle (35-21 days)
The existence of Early dysmenorrhea cramps in most menstrual cycles over the past 6 months
Having  4-10 score, based on visual analog pain Scale
Having a below score 92, based on the Menstrual Distress Questionnaire
Do not take psychiatric medications
Lack of sensitivity to tape
No history of alcohol use
No smoking
Having at least one of the diagnostic criteria for premenstrual syndrome</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having any disease that affects the results of study, including mental illness and genital disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dysmenorrhea, unspecified, premenstrual syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Keynesian tape is a waterproof tape without chemical adhesive. The 3NS TEX brand, made in Korea, measures 5 cm by 5 m. It is installed by a researcher for two menstrual cycles from 5 days before menstruation, after 5 days it is removed by the person and after 24 hours of skin respiration, Re-installed by the researcher and left on the site for another 5 days. In total, the tape is installed on the pain area for 10 days.</i_keyword>
      <i_keyword>Control group:  The actions taken for the intervention group are done exactly for the comparison group without real tape</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score on Visual Analogue Scale questionnaire. Timepoint: Measurement of Visual Analogue Scale  at the beginning and end of the study. Method of measurement: Visual Analogue Scale, menstrual distress questionaire.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-10</approval_date>
        <contact_name>Ethics committee of Orumieh University of Medical Sciences</contact_name>
        <contact_address>Jihad Square, next to the emergency Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
