<?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>IRCT20230902059328N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-10</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>pain relief during venipuncture in hemodialysis patients</public_title>
      <acronym>تاثیر بکار بردن سوزن سرد بر شدت درد ناشی از کانولاسیون فیستول شریانی –وریدی بیماران تحت همودیالیز</acronym>
      <scientific_title>Effect of insert a cooled needle on arteriovenous fistula puncture-related pain intensity in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72566</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Randomization description: The participants Were randomly assigned to either the intervention group (N=30)or the control group (N=30)using the permuted block technique with block sizes of 6 (AABABB-AAABBB-BABABA-ABABAB-BABABA-AAABBB-ABAABB-BBAABA-BBAABA)the assignment was determined by the random selection of blocks، with the letters A and B representing the control and intervention groups، respectively, Blinding description: The groups in the raw data are coded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: in group A (30), in the first and second sessions, cannulation will be performed with a No. 15 needles at room temperature, and in the third and fourth sessions, cannulation will be performed with a No. 15 needles cooled in the refrigerator (temperature -8 degrees). At the end,  the intensity of the patient's pain After piercing the artery and vein, the pain will be measured and recorded separately with a ruler. Intervention 2: Intervention gIn group B (30 people), in contrast to group A, in the first and second sessions, cannulation will be performed with a #15 needle cooled in the refrigerator (temperature -8 degrees) and in the third and fourth session, cannulation will be performed with a #15 needle at room temperature, and the pain intensity will be The patient will be measured and recorded separately after the puncture of the artery and vein.roup:.</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:
publish in journal related hemodyilysi

When:
no limitation

To whom:
researcher, nurses, students

Conditions:
site of journal, library in school of nursing and midwifery in Mashhad

Where to obtain:
Maryam bagheri (school of nursing and midwifery in Mashhad)

How to obtain:
email: bagherim@mums.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Kharazmi Complex, Ferdowsi University of Mashhad, Park Square, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9179133859</zip>
        <telephone>+98 51 3891 5597</telephone>
        <email>bagherim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Kharazmi Complex, Ferdowsi University of Mashhad, Park Square, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9179133859</zip>
        <telephone>+98 51 3891 5597</telephone>
        <email>bagherim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence of both arterial and venous fistula
At least one month elapsed since the creation of the fistula
Full consciousness and ability to articulate pain symptoms
Undergoing hemodialysis three time a week
Absence of dementia or Alzheimer s disease
No active cancer diagnosis
Proficiency in the persian language
Not currently using anesthesia
Having good vision
Willingness to participate in the study
Ability to communicate pain experiences
Stable hemodynamic status
Absence of muscle and joint injuries
Age 18and above</inclusion_criteria>
      <agemin>18 days</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Blood pressure below 80/40 mm Hg during fistula cannulation
Failure to insert the needle into the fistula on the first occasion
Presence of phlebitis at the cannulation site.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T85.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified complications of internal prosthetic devices, implants and grafts, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>in group A (30), in the first and second sessions, cannulation will be performed with a No. 15 needles at room temperature, and in the third and fourth sessions, cannulation will be performed with a No. 15 needles cooled in the refrigerator (temperature -8 degrees). At the end,  the intensity of the patient's pain After piercing the artery and vein, the pain will be measured and recorded separately with a ruler.</i_keyword>
      <i_keyword>Intervention gIn group B (30 people), in contrast to group A, in the first and second sessions, cannulation will be performed with a #15 needle cooled in the refrigerator (temperature -8 degrees) and in the third and fourth session, cannulation will be performed with a #15 needle at room temperature, and the pain intensity will be The patient will be measured and recorded separately after the puncture of the artery and vein.roup:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity after needle insertion with normal and cold temperature using 10 degree pain ruler. Timepoint: Session1، 2، 3، 4. Method of measurement: 10-point scale of pain.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-11</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Dr Kharazmi Complex, Ferdosi University, Park Squre, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
