<?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>IRCT2014110919862N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-01</date_registration>
      <primary_sponsor>Vice-Chancellor for Research, Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effects of foot reflexology massage on vital signs and anxiety pediatric undergoing chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology massage on vital signs and anxiety Following injection of chemotherapy drug in pediatric 6-12 years old in Kerman Afzalipour Hospital Oncology Center in 2015</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17653</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Leukemia. Condition 2: Chemotherapy.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group:&#13;
Foot reflexology massage for 20 minutes before the injection of chemotherapy drug in the intervention group, that conducted by researcher. That first relaxation Foot massage is done for 2 minutes and then foot reflexology massage for 8 minutes is reflected around the big toe and attention to four points, including solar plexus, pituitary, heart and liver, which in the middle of the foot, placed the massage. The massage is done with Baby oil that is not curative, Just for lubrication and convenience. Each foot reflexology points with using the middle part of the first paragraph of index finger and thumb and the fleshy part of the thumb researchers, with constant pressure to the 0/5 cm  and in the event that a third of white nail bed, without interruption fingers the skin of the feet, the massage is assigned in the form of era. Foot reflexology massage for every foot is 10 minutes and takes 20 minutes total for both legs.&#13;
This intervention done for patients in outpatient oncology center in Kerman. In the before intervention Preparations are will be given to the samples (A full description of intervention, Time Intervention, Time and manner chemotherapy, Allowing the patient to express feelings, Asking questions and Responding to questions asked by patients). Intervention 2: In the control group over the 20 minutes before the injection of chemotherapy medications no action was taken. Intervention 3: In the placebo group:&#13;
Do a simple touch of the foot for 20 minutes before the injection of chemotherapy drug in the placebo group, that conducted by researcher. The simple touch for every foot is 10 minutes and takes 20 minutes total for both legs.&#13;
This intervention done for patients in outpatient oncology center in Kerman. In the before intervention Preparations are will be given to the samples (A full description of intervention, Time Intervention, Time and manner chemotherapy, Allowing the patient to express feelings, Asking questions and Responding to questions asked by patients).</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>sakineh sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman, The beginning of the Haft Baghe Alavi Road, Kerman University of Medical Sciences Campus, School of Razi Nursing and Midwifery</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76177</zip>
        <telephone>+98 34 3131 5219</telephone>
        <email>aghazavi114@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman, The beginning of the Haft Baghe Alavi Road, Kerman University of Medical Sciences Campus, School of Razi Nursing and Midwifery</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76177</zip>
        <telephone>+98 34 3131 5219</telephone>
        <email>S_Sabzevari@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Having aged between 6 to 12 years;  having a case in Kerman Oncology Center; having leukemia; Using the same chemotherapy drug; Having a member's health in the legs; No history of foot reflexology.Exclusion criteria: Having physical problems (Verbal, Visual, Mental, Hearing); using of Anti-Anxiety drugs.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C91, C92, </hc_code>
      <hc_code>Z50, Z51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lymphoid leukaemia, Myeloid leukaemia,  Monocytic leukaemia, Other leukaemias of specified cell type, Leukaemia of unspecified cell type</hc_keyword>
      <hc_keyword>Care involving use of rehabilitation procedures, Other medical care</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group:&#13;
Foot reflexology massage for 20 minutes before the injection of chemotherapy drug in the intervention group, that conducted by researcher. That first relaxation Foot massage is done for 2 minutes and then foot reflexology massage for 8 minutes is reflected around the big toe and attention to four points, including solar plexus, pituitary, heart and liver, which in the middle of the foot, placed the massage. The massage is done with Baby oil that is not curative, Just for lubrication and convenience. Each foot reflexology points with using the middle part of the first paragraph of index finger and thumb and the fleshy part of the thumb researchers, with constant pressure to the 0/5 cm  and in the event that a third of white nail bed, without interruption fingers the skin of the feet, the massage is assigned in the form of era. Foot reflexology massage for every foot is 10 minutes and takes 20 minutes total for both legs.&#13;
This intervention done for patients in outpatient oncology center in Kerman. In the before intervention Preparations are will be given to the samples (A full description of intervention, Time Intervention, Time and manner chemotherapy, Allowing the patient to express feelings, Asking questions and Responding to questions asked by patients)</i_keyword>
      <i_keyword>In the control group over the 20 minutes before the injection of chemotherapy medications no action was taken</i_keyword>
      <i_keyword>In the placebo group:&#13;
Do a simple touch of the foot for 20 minutes before the injection of chemotherapy drug in the placebo group, that conducted by researcher. The simple touch for every foot is 10 minutes and takes 20 minutes total for both legs.&#13;
This intervention done for patients in outpatient oncology center in Kerman. In the before intervention Preparations are will be given to the samples (A full description of intervention, Time Intervention, Time and manner chemotherapy, Allowing the patient to express feelings, Asking questions and Responding to questions asked by patients)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Immediately before the intervention and immediately after injection of chemotherapy. Method of measurement: Observational Scale behavior Disress- Rare.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Immediately before the intervention and immediately after injection of chemotherapy. Method of measurement: The using of mercury manometers  in terms of millimeters of mercury.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Immediately before the intervention and immediately after injection of chemotherapy. Method of measurement: The using of mercury manometers  in terms of millimeters of mercury.</prim_outcome>
      <prim_outcome>Pulse. Timepoint: Immediately before the intervention and immediately after injection of chemotherapy. Method of measurement: Radial pulse count based on the number of minutes.</prim_outcome>
      <prim_outcome>Respiratory Rate. Timepoint: Immediately before the intervention and immediately after injection of chemotherapy. Method of measurement: Counting up and down movements of the chest in terms of number of minutes.</prim_outcome>
      <prim_outcome>Temperature. Timepoint: Immediately before the intervention and immediately after injection of chemotherapy. Method of measurement: Axillary thermometers in degrees Centigrade.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient satisfaction. Timepoint: During the intervention and during chemotherapy drug injection. Method of measurement: The question of research units.</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>Vice-Chancellor for Research, Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-20</approval_date>
        <contact_name>Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman, Crossroads Tahmasebabad, Kerman University of Medical Sciences Research and Technology Centre Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
