<?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>IRCT20180304038936N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-16</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Foot Reflexology on Stress, Anxiety, Depression and Serum Cortisol levels in Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effect of Foot Reflexology on Stress, Anxiety, Depression and Serum Cortisol levels in Hemodialysis Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31336</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Blinding description: Patients, doctors and nurses do not say which patients are in the control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: stress. Condition 2: Depression. Condition 3: Anxiety. Condition 4: Serum cortisol levels. Condition 5: Reflexology. Condition 6: Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, the stages of reflextive massage are described. Participants are asked to lie on the hemodialysis bed and close their eyes and put themselves in a state of tranquility. Foot reflexology massage is done an hour after starting dialysis  for 30 minutes (15 minutes for each foot), first for the left leg and then for the right one.To massage the feet, warm your hands.Hold the heel with the left hand and bending and straightening it from the ankle with push the planter.  Then enter direct pressure with the thumb on the solar plexus and this is done 3 times a week for 4 weeks each session for 15 minutes per foot (6 minutes of pressure and 3 minutes rest and again 6 minutes of pressure) and rotationally and with the pressure applied to the patient's tolerance. Intervention 2: Control group: By creating the same conditions with the intervention group, simple massage of the foot without compression of the standard reflexology massage points is performed with the same duration as the intervention 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Shanbepour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Minab, Hormozgam</address>
        <city>Minab</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7997193149</zip>
        <telephone>+98 76 4232 7277</telephone>
        <email>zahra.shanbpour@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ahmad Reza Sayadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Street, School of Nursing and Midwifery</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34345900</telephone>
        <email>sayadiahmad@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 18 years
Dialysis for at least 3 months and at least 3 times a week, each time for 4-3 hours
The absence of limb amputation or ulcer at the site of reflexology
Absence of chronic and debilitating disease(Cancer, Chronic Respiratory Failure, Heart Failure, Rheumatoid Arthritis, Lupus Erythematosus)
Not having a physical disability or a clear mental disorder that disables the patient in self-care
The absence of coagulation disorders(due to the possibility of clot and thromboembolism)
Not having a history of taking relaxing medications and antidepressants, cigarette and drug addiction
The absence of neuropathy in the feet
Not having a history of incident in the last 6 months
Having written consent to participate in the study
Non-use of other side therapies and complementary</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue participation in study;
During the study, refer to kidney transplants or peritoneal dialysis;
Hemodynamic complications in most dialysis sessions;
Absence more than three sessions;
Death during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z63.7</hc_code>
      <hc_code>F32.9</hc_code>
      <hc_code>F06.4</hc_code>
      <hc_code>E27.9</hc_code>
      <hc_code></hc_code>
      <hc_code>Z63.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety (normal) about sick person in family Health problems within family Ill or disturbed family member Isolated family</hc_keyword>
      <hc_keyword>Depression NOS Depressive disorder NOS</hc_keyword>
      <hc_keyword>A disorder characterized by the essential descriptive features of a generalized anxiety disorder (F41.1), a panic disorder (F41.0), or a combination of both, but arising as a consequence of an organic disorder.</hc_keyword>
      <hc_keyword>Disorder of adrenal gland, unspecified</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Dialysis (renal) NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, the stages of reflextive massage are described. Participants are asked to lie on the hemodialysis bed and close their eyes and put themselves in a state of tranquility. Foot reflexology massage is done an hour after starting dialysis  for 30 minutes (15 minutes for each foot), first for the left leg and then for the right one.To massage the feet, warm your hands.Hold the heel with the left hand and bending and straightening it from the ankle with push the planter.  Then enter direct pressure with the thumb on the solar plexus and this is done 3 times a week for 4 weeks each session for 15 minutes per foot (6 minutes of pressure and 3 minutes rest and again 6 minutes of pressure) and rotationally and with the pressure applied to the patient's tolerance.</i_keyword>
      <i_keyword>Control group: By creating the same conditions with the intervention group, simple massage of the foot without compression of the standard reflexology massage points is performed with the same duration as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression scores on standard questionnaires for depression, anxiety and stress 21 questions. Timepoint: Session before and after intervention. Method of measurement: Standard questionnaire for depression, anxiety and stress 21 questions(DASS-21).</prim_outcome>
      <prim_outcome>Anxiety scores on standard questionnaires for depression, anxiety and stress 21 questions. Timepoint: Session before and after intervention. Method of measurement: Standard questionnaire for depression, anxiety and stress 21 questions (DASS-21).</prim_outcome>
      <prim_outcome>Stress scores on standard questionnaires for depression, anxiety and stress 21 questions. Timepoint: Session before and after intervention. Method of measurement: Standard questionnaire for depression, anxiety and stress 21 questions.</prim_outcome>
      <prim_outcome>Serum cortisol levels. Timepoint: Session before and after intervention. Method of measurement: enzyme-linked immunosorbent assay test (ELISA test).</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-09</approval_date>
        <contact_name>Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Central Office of Medical Sciences,Imam Ali Blvd Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
