<?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>IRCT20220612055152N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-10</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>"effect of cold therapy on pain"؛ "effect of Hugo point cold therapy on pain"</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effect  of Cryotherapy on Hugo point and the Pain of Vascular Needles Insertion in Hemodialysis Patient</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65006</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method is simple.
The randomization unit is individual.
The randomization tool is the table of random numbers.
We number the statistical community from 1 to the last... and record each of the numbers on similar and identical small cards. Then we put all the cards in a box and every time after shaking the box, we randomly take out one card from the box and record its number. We continue this process until the desired number of sample units is obtained.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cold therapy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients are divided into two intervention groups, first and second. The cooler used in this research is made by YAKHPACK company of Iran. Its dimensions are 10 x 10 cm and its weight is approximately 100 grams, which is made of gelatinous and non-toxic materials. The alcohol pad used is from Saba Tab Company. The patients of the first intervention group are placed in the venipuncture site under the intervention of using an ice pack. In this method, the needle entry point is marked before placing the ice pack. Then The ice pack is placed for 10 minutes on the place where the vascular needles are inserted and moved clockwise with medium pressure. (During 10 minutes: 15 seconds of rest for every 2 minutes). After ten minutes, the ice pack is removed and the area is sterilized with an alcohol pad, after which cannulation is performed, and then pain intensity is measured with a Visual Analogue Scale tool within 1 minute after cannulation. Intervention 2: Intervention group: The patients of the second intervention group are placed in Hugo's point under the intervention of using an ice pack. In this method, the ice pack is moved for 10 minutes on the Hugo point, between the thumb and forefinger, on the back of the hand opposite to the cannulation, with moderate pressure, in a clockwise direction. (During 10 minutes: 15 seconds of rest for every 2 minutes). After ten minutes, the cannulation is done and then within 1 minute after the cannulation, the pain level is measured with the Visual Analogue Scale tool.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Sasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>22 Bahman St., Postal code 3813747773</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3813747773</zip>
        <telephone>+98 86 3222 9403</telephone>
        <email>atefeh.sasani82@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Sasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>22 Bahman St., Postal code 3813747773</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3813747773</zip>
        <telephone>+98 86 3222 9403</telephone>
        <email>atefeh.sasani82@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness of the patient to participate in the study and have informed consent
The patient's age should be between 18-70 years.
The patient should have consciousness, verbal ability and normal sensation.
Cannulation is not an emergency.
The patient should not have any other pain in the hands except the pain caused by the cannulation.
Lack of anesthesia and neuropathy disorders and peripheral vascular diseases at the cannulation site
Do not have a history of mental illness.
The patient has not used painkillers, anesthetics or drugs in the last 8 hours.
Do not have skin problems such as eczema, burns, wounds or skin cuts at the cannulation site.
Having a fistula, at least 3 months.
The patient should undergo hemodialysis 3 times a week.
Regular hemodialysis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient's unwillingness to cooperate with the study
Allergy to cold
Improper cannulation angle or more than one cannulation attempt</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients are divided into two intervention groups, first and second. The cooler used in this research is made by YAKHPACK company of Iran. Its dimensions are 10 x 10 cm and its weight is approximately 100 grams, which is made of gelatinous and non-toxic materials. The alcohol pad used is from Saba Tab Company. The patients of the first intervention group are placed in the venipuncture site under the intervention of using an ice pack. In this method, the needle entry point is marked before placing the ice pack. Then The ice pack is placed for 10 minutes on the place where the vascular needles are inserted and moved clockwise with medium pressure. (During 10 minutes: 15 seconds of rest for every 2 minutes). After ten minutes, the ice pack is removed and the area is sterilized with an alcohol pad, after which cannulation is performed, and then pain intensity is measured with a Visual Analogue Scale tool within 1 minute after cannulation.</i_keyword>
      <i_keyword>Intervention group: The patients of the second intervention group are placed in Hugo's point under the intervention of using an ice pack. In this method, the ice pack is moved for 10 minutes on the Hugo point, between the thumb and forefinger, on the back of the hand opposite to the cannulation, with moderate pressure, in a clockwise direction. (During 10 minutes: 15 seconds of rest for every 2 minutes). After ten minutes, the cannulation is done and then within 1 minute after the cannulation, the pain level is measured with the Visual Analogue Scale tool.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in Visual Analogue Scale tool. Timepoint: Within 1 minute after cannulation, the pain level is measured with the Visual Analogue Scale tool. Method of measurement: Visual Analogue Scale  tool.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-07</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>22 Bahman St., Postal code 3813747773 Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
