<?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>IRCT201412087529N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-16</date_registration>
      <primary_sponsor>Shahed University Vice chancellor for research</primary_sponsor>
      <public_title>Effect of massage  on the level of anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison between of foot and hand reflexology on anxiety in patients with angiography candidates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-10-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8015</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The patients are randomly allocated in to the three study groups: foot reflexology massage, hand reflexology massage and control group (35 patients in each group). Random allocated to intervention and control groups, assign patients were given this manner: (first week for foot reflexology, second week for hand reflexology massage, third week for control group and again this random allocation is repeated )The researchers and data monitoring committee will not become aware of what sort of intervention the patients receive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety in patients with angiographic candidates.</hc_freetext>
      <i_freetext>Intervention 1: In foot reflexology massage group is done 20 minutes.(10 minutes for per foot). &#13;
massage techniques on reflex points of the pituitary, spinal cord and solar plexus .reflection of the pituitary is in inner edge of middle portion in the first Knucklebone of the big in plantar plantar, solar plexus is in end of the first metatarsal bone in foot and reflection of the spinal cord is in the inner edge of the foot, starting from the end of the first Knucklebone of the thumb and leads to heel. The level of anxiety (measured by using spielburger questionnaire) and  hemodynamic parameters (recorded in a checklist) are used before intervention , one minute after intervention, and one minute after angiography. Intervention 2: In hand reflexology massage group is done 20 minutes.(10 minutes for per hand).In the hand Reflexology group for the points massage, including the pituitary gland and solar plexus is performed. The level of anxiety (measured by using spielburger questionnaire) and hemodynamic parameters (recorded in a checklist) are used before and after intervention, while and after angiography. Intervention 3: control group without any intervention.</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>Fatemeh Heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University-Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>021</zip>
        <telephone>+98 21 51210</telephone>
        <email>fatemeh_heidari19@yahoo.com , &#13;
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 ,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 51210</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>nclusion criteria: the desire to participate in the study; having no previous history of angiography; having no order of emergency angiography; having 20 number anxiety; age over 18 years old;; health in the legs and hands; patients not taking the narcotic drug alcohol, ; having no previous history of mental disorder; not using anticoagulation medications; No diabetes; Do not have the risk of deep vein thrombosis. Exclusion criteria: injury or infection at the site of reflex zone therapy; anxiolytic or hypnotic drugs in the 8 hours before reflex zone therapy; condition of hemodynamic is unstable; transfer of patient to intensive care unit and cardiopulmonary resuscitation of the patient.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40-48</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neurotic, stress-related and somatoform disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In foot reflexology massage group is done 20 minutes.(10 minutes for per foot). &#13;
massage techniques on reflex points of the pituitary, spinal cord and solar plexus .reflection of the pituitary is in inner edge of middle portion in the first Knucklebone of the big in plantar plantar, solar plexus is in end of the first metatarsal bone in foot and reflection of the spinal cord is in the inner edge of the foot, starting from the end of the first Knucklebone of the thumb and leads to heel. The level of anxiety (measured by using spielburger questionnaire) and  hemodynamic parameters (recorded in a checklist) are used before intervention , one minute after intervention, and one minute after angiography</i_keyword>
      <i_keyword>In hand reflexology massage group is done 20 minutes.(10 minutes for per hand).In the hand Reflexology group for the points massage, including the pituitary gland and solar plexus is performed. The level of anxiety (measured by using spielburger questionnaire) and hemodynamic parameters (recorded in a checklist) are used before and after intervention, while and after angiography</i_keyword>
      <i_keyword>control group without any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Satisfaction. Timepoint: 30 minutes after angiography. Method of measurement: satisfaction Visual Analog Scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention , one minute after intervention, and one minute after angiography. Method of measurement: Spielberger questionnaire.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before intervention , one minute after intervention, and one minute after angiography. Method of measurement: phygmomanometer.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before intervention , one minute after intervention, and one minute after angiography. Method of measurement: Checklist.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: Before intervention , one minute after intervention, and one minute after angiography. Method of measurement: Checklist.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: Before intervention , one minute after intervention, and one minute after angiography. Method of measurement: pulse oximeter.</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>Shahed University Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-09</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way , Tehran ,Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
