<?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>IRCT201711107529N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-20</date_registration>
      <primary_sponsor>Shahed University Vice Chancellor For Research</primary_sponsor>
      <public_title>Comparing the effect of foot reflexology and acupressure on treatment of headache in patient receiving Nitroglycerin infusion</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of foot reflexology and acupressure on treatment of headache in patient receiving Nitroglycerin infusion in female patients admitted to cardiac emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8025</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Eligible patients will be selected through convenience sampling and will be randomly assigned into 2 groups using permuted block randomization with allocation ratio of 1: 1: 1. Random allocation sequence will be determined using a computerized program. Opaque sealed sequentially numbered envelopes from number 1 to 99 will be used for allocation concealment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Drug-induced headache.</hc_freetext>
      <i_freetext>Intervention 1: The intervention is reflexology massage, the upper part of the patient's toe, the spot of reflection related to head will be massaged for both legs in the intervention group at two steps for 20 minutes. The intervention is acupressure, the upper part of the patient's toe, the spot of reflection related to head will be massaged for both legs in the intervention group at two steps for 20 minutes. Intervention 2: In intervention group acupressore will be done in hegu point for 2 minutes and rest for 2 minutes and this procidure was repeated for 10 minutes. At 15 minutes after the first intervention, the second intervention will be repeated for 10 minutes. Intervention 3: Touch will perform that is not linked to head will be massaged in the placebo group.</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>Dr. Nahid Rejeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5121 3071</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nahid Rejeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5121 3071</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: willing to participate in the study; age between 18 to 65; The absence of verbal and visual disorders; The absence of sensory-motor disorders; The absence of advanced neurological disorders; The absence of clotting problems, peripheral vascular disease, peripheral neuropathy and DVT limb; The absence of diagnosed psychiatric disorder; The absence of a headache before the administration of Nitroglycerine; the absence of any history of headache in patients; not having an addiction to drugs, sedatives, alcohol; Not using analgesics and nerve- muscle blockers 4 hours before the intervention; not having a long history of taking Nitroglycerine; The absence of history of using reflexology or acupressure; Not using of steroidal and non-steroidal anti-inflammatory drugs, anticoagulation, chemotherapy.                              &#13;
Exclusion criteria: Incidence of severe complications during the study; Pain in other parts of the body other than the head; the severity of the pain so that the patient can not tolerate; Use analgesics drugs during the study; Dissatisfaction of attending physician or patient.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G44.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Drug-induced headache, not elsewhere classified</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>The intervention is reflexology massage, the upper part of the patient's toe, the spot of reflection related to head will be massaged for both legs in the intervention group at two steps for 20 minutes. The intervention is acupressure, the upper part of the patient's toe, the spot of reflection related to head will be massaged for both legs in the intervention group at two steps for 20 minutes.</i_keyword>
      <i_keyword>In intervention group acupressore will be done in hegu point for 2 minutes and rest for 2 minutes and this procidure was repeated for 10 minutes. At 15 minutes after the first intervention, the second intervention will be repeated for 10 minutes.</i_keyword>
      <i_keyword>Touch will perform that is not linked to head will be massaged in the placebo group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of headache. Timepoint: Before the intervention , after the first intervention and after second  intervention. Method of measurement: Visual Analog  Pain Scale.</prim_outcome>
      <prim_outcome>Quality of headache. Timepoint: Before the intervention, after the first intervention and after second  intervention. Method of measurement: McGill Pain Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: Before the intervention, after the first intervention and after second intervention. Method of measurement: Monitoring system.</sec_outcome>
      <sec_outcome>Systolic Blood pressure. Timepoint: Before the intervention, after the first intervention and after second intervention. Method of measurement: Monitoring system.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before the intervention, after the first intervention and after second intervention. Method of measurement: Monitoring system.</sec_outcome>
      <sec_outcome>Mean blood pressure. Timepoint: Before the intervention, after the first intervention and after second intervention. Method of measurement: Monitoring system.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: Before the intervention, after the first intervention and after second intervention. Method of measurement: Monitoring system.</sec_outcome>
      <sec_outcome>Oxygen saturation of arterial blood. Timepoint: Before the intervention, after the first intervention and after second intervention. Method of measurement: pulse oximeter.</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>Shahed University Vice Chancellor For Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-06</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
