<?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>IRCT2015081423615N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-18</date_registration>
      <primary_sponsor>Vice Chancellor for Reaserch of  Islamic Azad University Isfahan</primary_sponsor>
      <public_title>Comparison of the effects of ice massage and Valsalva maneuver on pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of effect of two methods related to ice massage in Huko point and Valsalva maneuver on pain intensity during needle insertion into arteriovenous fistula of hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20122</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis patient.</hc_freetext>
      <i_freetext>Intervention 1: "control group: After disinfection of the arteriovenous fistula, without performing any action, inserting needle in to av fistula in contralateral hand with av fistula,  was done.". Intervention 2: " intervention group:  Using an ice ball with a diameter of 1.5-2 cm, was wrapped in a plastic glove, the space between the thumb and forefinger of cotralateral hand with fistula, 10 minutes before and 2 minutes  during insertion of needle in to the avf,circular was  massaged. ". Intervention 3: "intervention group: The patients were asked to blow in the hole of disposable syringe that is placed in one side plastic tube manometer   and the other end of tube,  was connected to the sphygnomanometer and lift mercury column  up to 20 mm Hg and maintain  height of the mercury column  for 20 seconds to 20 mmHg. 20 seconds after,  inserting needle in arteriovenous fistula was 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Davtalab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.48;Shahid Sheikhi; Shahid Vaezi Street; Valashan; Dorcheh</address>
        <city>Khomeini Shahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>84371773376</zip>
        <telephone>+98 31 3375 0848</telephone>
        <email>e.davtalab@khuisf.ac.ir  ;Davtalab.elham@yahoo.com</email>
        <affiliation>Islamic Azad University Isfahan (Khorasgan) Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Ali Naji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arghavanieh Blvd; East J Street</address>
        <city>Khorasgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>158-81595</zip>
        <telephone>+98 31353540019</telephone>
        <email>info@khuisf.ac.ir</email>
        <affiliation>Islamic Azad University Isfahan (Khorasgan) Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients in the study are hemodialysis; dialysis performed from arteriovenous fistula; be willing to participate in the study; older than 18 years; fully conscious and able to answer their questions; verbal and visual communication can be achieved; no sever pain in the body area before inserting the needle into the fistula ; history of drug abuse not mentioned; during the 6 hours before hemodialysis is not used analgesics or sedatives;avf cannulation is possible  to one try of cannulation; history of diseases such as Alzheimer's, dementia, peripheral vascular disease, diabetic neuropathy disorders not mentioned; heart disease, glaucoma, increased pressure in the brain, the eyes do not have a recent surgery ; have not inflammation and damage, redness, pain and bruise on the skin av fistula; does not mention sensitivity to ice massage;be able to perform the Valsalva maneuver and keeping the mercury column manometer to the pressure of 20 mmHg for 20 seconds .&#13;
Exclusion criteria:the patient's unwillingness to continue participating in the study;&#13;
Death and absence in the second session to continue treatment; the lack of proper venipuncture every effort in the second session of hemodialysis; the use of a sedative before the start of the second session of hemodialysis;inability to perform the Valsalva maneuver correctly.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>End stage kidney disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"control group: After disinfection of the arteriovenous fistula, without performing any action, inserting needle in to av fistula in contralateral hand with av fistula,  was done."</i_keyword>
      <i_keyword>" intervention group:  Using an ice ball with a diameter of 1.5-2 cm, was wrapped in a plastic glove, the space between the thumb and forefinger of cotralateral hand with fistula, 10 minutes before and 2 minutes  during insertion of needle in to the avf,circular was  massaged. "</i_keyword>
      <i_keyword>"intervention group: The patients were asked to blow in the hole of disposable syringe that is placed in one side plastic tube manometer   and the other end of tube,  was connected to the sphygnomanometer and lift mercury column  up to 20 mm Hg and maintain  height of the mercury column  for 20 seconds to 20 mmHg. 20 seconds after,  inserting needle in arteriovenous fistula was performed."</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Objective pain. Timepoint: Before and immediately after the intervention. Method of measurement: Abbey pain scale.</prim_outcome>
      <prim_outcome>Subjective pain. Timepoint: Before and immediately after the intervention. Method of measurement: Numerical Rating  Scale 0-10.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bloold pressure and pulse rate. Timepoint: 10 minute prior of cannulation and 5 minute after the cannulation. Method of measurement: Heart and blood pressure monitoring device.</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>Vice Chancellor for Reaserch of  Islamic Azad University Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-09</approval_date>
        <contact_name>Etichs Committee of Isfahan University of Medical Sciences and Health Services</contact_name>
        <contact_address>Hezarjarib Street Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
