<?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>IRCT2017090517756N28</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-19</date_registration>
      <primary_sponsor>Vice-chancellery for Research, Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology massage on stress and neuropathic pain induced by chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>A comparison between the effects of application versus non-application of foot reflexology massage on stress and neuropathic pain induced by chemotherapy in women with breast cancer and genital organs</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16268</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: breast cancer. Condition 2: Genital tract cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group (Foot reflexology message): Prior to the intervention, demographic characteristics form, Perceived Stress Scale (Cohen et al., 1983), and the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale will be completed by the group. The intervention group will receive foot reflexology massage for two weeks. Two weeks after the end of intervention, the group will complete the two scales for a second round. Intervention 2: Control Group (No intervention): Prior to the intervention, demographic characteristics form, Perceived Stress Scale (Cohen et al., 1983), and the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale will be completed by the group. The control group will not receive any intervention. Two weeks after the end of intervention, the group will complete the two scales for a second round.</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 Hosain Rezaei Mohebbati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley No. 16., Janbazan Blvd.,</address>
        <city>Boshrouyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+56 32224687</telephone>
        <email>SHRM37@YAHOO.COM</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tayebeh Khazaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Birjand University of Medical Sciences, Ayatollah Ghaffari Street,</address>
        <city>Birjand,</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3238 1433</telephone>
        <email>thayebehk@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Definitive diagnosis of breast cancer; malignancy based on pathological studies, clinical findings, and physician diagnosis; women treated with Taxon; age between 18 and 60 years; neuropathic pain induced by chemotherapy with a score of 12 or more according to the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale; reading and writing literacy and the ability to speak for the patient or caregiver; having healthy limbs in the legs, especially the sole of the legs or lack of sensory and motor disorders; no drug abuse; non-use of psychotropic drugs; no history of mental illness; informed consent for participation; and the use of prophylaxis drugs for neuropathic pains such as gabapentin and pre-cabalin. &#13;
Exclusion criteria: Metastasis for bone marrow, lung, liver and kidneys; patient's lack of cooperation until the end of the intervention; and the presence of stressors such as the death of first-degree relatives, divorce, and severe changes in lifestyle over the past 6 months.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D05</hc_code>
      <hc_code>C57.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carcinoma in situ of breast</hc_keyword>
      <hc_keyword>Female genital organ, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group (Foot reflexology message): Prior to the intervention, demographic characteristics form, Perceived Stress Scale (Cohen et al., 1983), and the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale will be completed by the group. The intervention group will receive foot reflexology massage for two weeks. Two weeks after the end of intervention, the group will complete the two scales for a second round.</i_keyword>
      <i_keyword>Control Group (No intervention): Prior to the intervention, demographic characteristics form, Perceived Stress Scale (Cohen et al., 1983), and the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale will be completed by the group. The control group will not receive any intervention. Two weeks after the end of intervention, the group will complete the two scales for a second round.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived stress. Timepoint: before intervention and 2 weeks after intervention is completed. Method of measurement: Cohen et al.’s Perceived Stress Scale.</prim_outcome>
      <prim_outcome>Neuropathic pain severity. Timepoint: before intervention and 2 weeks after intervention is completed. Method of measurement: The Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale.</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>Vice-chancellery for Research, Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-01</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Vice-chancellery for Research, Birjand University of Medical Sciences, Ghaffari St., Birjand,  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
