<?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>IRCT2014013016426N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-11-30</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences - Vice Chancellor for Research</primary_sponsor>
      <public_title>The effect of foot reflexology on the pain intensity and frequency of patients with tension headache</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology on the pain intensity and frequency of patients with tension headache</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-10-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15372</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tension headache.</hc_freetext>
      <i_freetext>Intervention 1: How do reflexology, in which case the patient lying in the supine position and opposite the clinician and the patient is placed in a quiet environment. Preparations will be carried out before the main technique used to relieve tension and muscle spasms in the body. The toes with one hand and the other hand supporting his fists and feet to the junction of the fingers to the knuckles of the second leg, we massage it down. The medial border of the foot to the big toe side of the wrist to the ankle with a little pressure to make massage (performed three times on each leg).Reflexology in the footsteps of:1-point pituitary, leading the toe of the foot to the point of reflection for the pituitary is rotating clockwise massage for 3 minutes and we left.2. Solar Network: their hands in the shape of a cross. He then places a thumb on the cognitive reflection, as we do in the middle of the foot troughs. Thumbs on the inside leg and three times for 3 min massage is given.3-point reflects the brain: the tip of your toes all within 3 minutes of massage can be arranged at the outside of the thumb. At the last meeting the right and left foot and gently massage to give a blow, and then cover the legs. The patient breathe deeply and say 3 times at the end of the massage, the patient is recommended to drink plenty of fluids this intervention will be done by the researcher who specialized courses reflexology specialist is trained and certified for men and for women by a woman who specialized courses reflexology specialist is trained and certified in the site of clinics and room choice that has already been done. Intervention 2: In the control group no intervention will be done.  Just before, during and after the study questionnaires related to the frequency and severity of headaches is completed.</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>Seyed Hossein Vaezzdeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Nosrat st., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6105 4326</telephone>
        <email>vaezzadeh1@gmail.com; h-vaezzadeh@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Forough Rafii</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Rashid Yasemi st., After Vanak sq., Valiasr st.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8888 0888</telephone>
        <email>foroughrafii@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: willingness to participate in the study; written informed consent to participate in the study; tension headache diagnosis according to the patient's medical records; people with tension headaches have been to the doctor several times over; age over 18 years old; the ability of listening, speaking, and acceptable alertness for responding; no numbness, or paralysis of leg ulcers; drug and alcohol consumption; no record of having psychological disorders or psychosis; absence epilepsy; lack of cancer, especially lymphoma and nerve damage caused by diabetes; no risk of brain AVM; lack of headache medication escalation.&#13;
Exclusion criteria:  no consent to proceed with the project; create or constitute any kind of side effects in the patient's legs cross over study; acute infectious disease during the study.&#13;
• Not completing the maximum two-week diary</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G44.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tension-type headache</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>How do reflexology, in which case the patient lying in the supine position and opposite the clinician and the patient is placed in a quiet environment. Preparations will be carried out before the main technique used to relieve tension and muscle spasms in the body. The toes with one hand and the other hand supporting his fists and feet to the junction of the fingers to the knuckles of the second leg, we massage it down. The medial border of the foot to the big toe side of the wrist to the ankle with a little pressure to make massage (performed three times on each leg).Reflexology in the footsteps of:1-point pituitary, leading the toe of the foot to the point of reflection for the pituitary is rotating clockwise massage for 3 minutes and we left.2. Solar Network: their hands in the shape of a cross. He then places a thumb on the cognitive reflection, as we do in the middle of the foot troughs. Thumbs on the inside leg and three times for 3 min massage is given.3-point reflects the brain: the tip of your toes all within 3 minutes of massage can be arranged at the outside of the thumb. At the last meeting the right and left foot and gently massage to give a blow, and then cover the legs. The patient breathe deeply and say 3 times at the end of the massage, the patient is recommended to drink plenty of fluids this intervention will be done by the researcher who specialized courses reflexology specialist is trained and certified for men and for women by a woman who specialized courses reflexology specialist is trained and certified in the site of clinics and room choice that has already been done.</i_keyword>
      <i_keyword>In the control group no intervention will be done.  Just before, during and after the study questionnaires related to the frequency and severity of headaches is completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity and frequency of pain. Timepoint: Before, during and after intervention. Method of measurement: Headache diary.</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>Tehran University of Medical Sciences - Vice Chancellor for Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-29</approval_date>
        <contact_name>Tehran University of Medical Sciences - Vice Chancellor for Research</contact_name>
        <contact_address>Vice Chancellor for Research, Sixth Floor, Tehran University of Medical Sciences, Qods st., Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
