<?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>IRCT20231021059797N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-13</date_registration>
      <primary_sponsor>Zabol University of Medical Sciences</primary_sponsor>
      <public_title>Investigation the effectiveness of comprehensive nursing care on uremic pruritus, sleep quality and dialysis adequacy in patients undergoing hemodialysis treatment</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effectiveness of comprehensive nursing care on uremic pruritus, sleep quality and dialysis adequacy in patients undergoing hemodialysis treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73503</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, first, a list of patients who meet the research inclusion criteria will be prepared, and then by random allocation, the first person selected will be in the intervention group and the second person will be in the control group. It will be continued that all research samples are in one of two intervention or control groups, Blinding description: This study will be conducted as a controlled clinical trial (single-blind, meaning that the subjects do not know which of the groups they are in).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients treated with hemodialysis.</hc_freetext>
      <i_freetext>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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There are no plans to publish</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh fahraji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Milan7, Saadi66,Saadi street, Zahedan</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9813856365</zip>
        <telephone>+98 54 3326 0926</telephone>
        <email>atefeh.fahrajii@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hossein Shahdadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the civil registry, 11 Ferdowsi St, Zabul city, Sistan and Baluchestan Province</address>
        <city>Zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861734184</zip>
        <telephone>+98 54 3222 3947</telephone>
        <email>zb5950@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent to participate in the research
over 18 years of age
Having a history of hemodialysis for at least three months before
Having arteriovenous fistula
Not suffering from heart diseases, infectious diseases, diseases related to other serious disorders at least one month before the study
Performing hemodialysis three times a week for four hours each time
The same type of ultrafiltration of filter and round device during the study for each patient
Absence of liver problems
No drug addiction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Withdrawal from participation in the pageant
death, travel
Getting other diseases (infectious, cardiac, etc.) while doing research
The need to use drugs that affect uremic itching and their sleep quality while conducting research.
Having skin diseases or sleep disorders while doing research
Change in the dialysis pattern (number of sessions, dialysis hours, filter type, dialysis machine cycle, etc.) for any reason
Being in the link list
Drug use during the research period</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comprehensive nursing care. Timepoint: for 3 months. Method of measurement: through the researcher.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Uremic pruritus. Timepoint: for 3 months. Method of measurement: Itching 5-dimensional scale questionnaire.</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: for 3 months. Method of measurement: Pittsburgh Sleep Index Standard Questionnaire.</sec_outcome>
      <sec_outcome>Adequacy of dialysis. Timepoint: for 3 months. Method of measurement: Calculate the amount KT/V.</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>Zabol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-18</approval_date>
        <contact_name>Ethics Committee of Zabul University of Medical Sciences</contact_name>
        <contact_address>Sistan and Baluchistan province, Zabul city, 11 Ferdowsi St., next to the registry office zabol Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
