<?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>IRCT2014082518928N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-12</date_registration>
      <primary_sponsor>Research Deputy of Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect dialysate temperature reduce  on dialysis patients fatigue</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cold dialysate on post-dialysis fatigue syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17044</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>End stage renal disease.</hc_freetext>
      <i_freetext>dialysate temperature will be reduced to 35/5° C for group A in the second week and for group B in the first week and all patients(CROSSOVER) will be undergoing hemodialysis for three sessions with each temperature (35/5 and 37 ° C).</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>zohreh gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak, Basij Square, pardis University of Medical Sciences, Faculty of Nursing and Midwifery</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 8618634173036</telephone>
        <email>zms.1391@yahoo.com -ghzms.1391@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr mahbubeh sajjadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak, Basij Square, pardis University of Medical Sciences, Faculty of Nursing and Midwifery</address>
        <city>Arak,</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86133136055</telephone>
        <email>mahbubehsajjadi@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Age over 18 years, diagnosis end stage renal disease, Having a degrees from fatigue, , regular visit three times a week for dialysis ,Hemodialysis treatment for at least 6 months, stable hemodynamic conditions ,Willingness to participate in the study. Hearing ability, speech and consciousness  acceptable to answer the questions, Absence of cardiovascular disorders such as myocardial infarction, non-anemia H b&lt;8&#13;
exclusion criteria:&#13;
Unwillingness to continue treatment, complications during dialysis requires immediate medical attention, The loss of one of the inclusion criteria, the problem of vascular access, The incidence of severe cardiac problems during dialysis,Chills so severe that the patient is not able to continue dialysis, severe and uncontrollable vomiting.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XIV</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>N17-N19 Renal failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>dialysate temperature will be reduced to 35/5° C for group A in the second week and for group B in the first week and all patients(CROSSOVER) will be undergoing hemodialysis for three sessions with each temperature (35/5 and 37 ° C)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post diaysis Fatigue. Timepoint: After each three dialysis session. Method of measurement: piper fatigue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Temperature. Timepoint: Before and after each dialysis session. Method of measurement: Mercury thermometer axillary.</sec_outcome>
      <sec_outcome>Feeling cold and chills. Timepoint: During dialysis. Method of measurement: Monitoring patient.</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>Research Deputy of Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-11</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>Arak, Basij Square, pardis University of Medical Sciences, Faculty of Nursing and Midwifery Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
