<?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>IRCT20210725051986N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-03</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  cannulation in scarred and non-scarred areas on pain intensity and bleeding in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of fistula cannulation in scarred and non-scarred areas on pain intensity and bleeding in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57935</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: The available sample (74 patients) is selected based on the inclusion criteria and after extracting the patients' names and referring to the project statistical consultant, they are assigned a three-digit code 001 to 074. Using Random allocation statistical software by simple randomization method and sequence 001 to 074 in a row, the samples are divided into two groups A and B. In group A, first cannulation is performed at the scar site and in group B, first non-scar cannulation is performed and in the next stage, the interventions are shifted.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 74 patients are cross-selected for intervention based on inclusion criteria. After extracting, the patients' names were coded and they were placed in one of the two study groups using random allocation software. Intravenous arterial needle No. 20 hemodialysis made by the company Medwayteb and is placed in the fistula at least from a distance of 5 cm from the fistula with an angle of 30 to 40 degrees while the diagonal part of the needle is high. This is done in the first session according to the random allocation to determine the priority in terms of placement in the scar or non-scar fistula and in the next session vice versa for each patient. Intervention 2: Control group: The same interventions of the intervention group are performed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information will be published without the names of participants and hospitals. Confidentiality of personal information will be assured

When:
After the publication of the results and the final defense of the dissertation

To whom:
Supervisor, members of the faculty / university research committee

Conditions:
Improving patient conditions and use for evidence-based care

Where to obtain:
Dr. Mostafa Javadi

How to obtain:
Written request from the researcher or scientific organizations and the university

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Taybeh Dehghani firoozabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Naser Zarei Aly., Shahid Mirbagheri Str.</address>
        <city>Meybod</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8961817955</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>Tay.dehghani@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mostafa Javadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadoughi School of Nursing and Midwifery, in front of Infertility Center, Safaieh St., Bouali Blvd.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>javadinurse@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 3 months of history of hemodialysis through fistula
Alertness
Age over 18 years
No difficulty in accessing blood vessels
Lack of neuropathy and patients with peripheral vascular injuries</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Malignancy and severe infection
Patients with skin diseases in or around the fistula
Patients who need surgery due to fistula dysfunction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preparatory care for renal dialysis</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: 74 patients are cross-selected for intervention based on inclusion criteria. After extracting, the patients' names were coded and they were placed in one of the two study groups using random allocation software. Intravenous arterial needle No. 20 hemodialysis made by the company Medwayteb and is placed in the fistula at least from a distance of 5 cm from the fistula with an angle of 30 to 40 degrees while the diagonal part of the needle is high. This is done in the first session according to the random allocation to determine the priority in terms of placement in the scar or non-scar fistula and in the next session vice versa for each patient.</i_keyword>
      <i_keyword>Control group: The same interventions of the intervention group are performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The average pain score on the visual analogue scale. Timepoint: After insertion of the needle into the fistula in both methods studied. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>The amount of bleeding after the needle is removed from the fistula. Timepoint: After removal of the needle from the fistula in both methods studied. Method of measurement: Standard Future model scales with a sensitivity of 0.01 g.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient preference for using the cannulation method. Timepoint: After interventions. Method of measurement: ًuestionnaire.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-08</approval_date>
        <contact_name>Research Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Central Administration, Bahonar Sq., Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
