<?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>IRCT2016050427744N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-11</date_registration>
      <primary_sponsor>Vice Chancellor for research; Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Compare Zayla-Cream and ice compress on the level of stress, pain and cardiovascular response from due to needles insertion into arteriovenous fistula in hemodialysis.</public_title>
      <acronym></acronym>
      <scientific_title>Compare Zayla-Cream and ice compress on the level of stress, pain and cardiovascular response from due to needles insertion into arteriovenous fistula in hemodialysis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22666</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Arteriovenous fistula puncture-related complication in hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Interventions 1:&#13;
At first, the patients complete a demographic questionnaire, based on it, the qualified patients will be enrolled in the study.&#13;
At First week, the intensity of stress before injection and the intensity of pain after injection with putting of placebo will be evaluated and recorded by visual stress analogue scale and visual pain analogue Scale, respectively. Also heart and cardiovascular changes in arterial venous fistula will be measured before and after injection. Intervention 2: Interventions 2:&#13;
After one week, the intervention with Zaylapy cream will be done in which, in all patients, 10 minutes before inserting the needle in fistula, cream with the area of 5 cm2 will be applied to the area. Do not put a cover over the area, then the cream will be cleared and skin will be disinfected for Vncopanccher. Then, the intensity of stress before injection and the intensity of pain after injection with putting of placebo will be evaluated and recorded by visual stress analogue scale and visual pain analogue Scale, respectively. This intervention will be done at two intermittent Hemodialysis sessions. Intervention 3: Interventions 3:&#13;
In this group, 10 minutes before inserting the needle in fistula, ice will be placed around the fistula. Then the skin will be dried and disinfected and needle inserted in fistula. The intensity of stress and vital signs before injection and the intensity of pain and vital signs after injection will be evaluated and recorded.</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>Ziba Ghoreishi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud university of Medical Sciences and Health Services, Hafte-Tir Square, Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3239 3811</telephone>
        <email>ghoreyshi@shmu.ac.ir</email>
        <affiliation>Shahroud university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossin Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central building ofShahroud University of Medical Sciences,Hafte Tir Square, Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3239 3811</telephone>
        <email>h_ebrahimi43@yahoo.com</email>
        <affiliation>Shahroud university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age over 18 years; being vigilant to time, place and persons at the time collecting the information; Hemodialysis patients who have at least two session of dialysis at week; patients who have at least three months past of their fistula embedding; absence of damaged skin in the desired positions; no known allergy to local anesthetics; without alcohol and drugs consumption; the minimum level of literacy; no history of mental illness with doctor approval.&#13;
Exclusion criteria: Analgesic use in the past 24 hours; the patient's unwillingness to continue the study; the patient died.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T82.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mechanical complication of vascular dialysis catheter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions 1:&#13;
At first, the patients complete a demographic questionnaire, based on it, the qualified patients will be enrolled in the study.&#13;
At First week, the intensity of stress before injection and the intensity of pain after injection with putting of placebo will be evaluated and recorded by visual stress analogue scale and visual pain analogue Scale, respectively. Also heart and cardiovascular changes in arterial venous fistula will be measured before and after injection.</i_keyword>
      <i_keyword>Interventions 2:&#13;
After one week, the intervention with Zaylapy cream will be done in which, in all patients, 10 minutes before inserting the needle in fistula, cream with the area of 5 cm2 will be applied to the area. Do not put a cover over the area, then the cream will be cleared and skin will be disinfected for Vncopanccher. Then, the intensity of stress before injection and the intensity of pain after injection with putting of placebo will be evaluated and recorded by visual stress analogue scale and visual pain analogue Scale, respectively. This intervention will be done at two intermittent Hemodialysis sessions.</i_keyword>
      <i_keyword>Interventions 3:&#13;
In this group, 10 minutes before inserting the needle in fistula, ice will be placed around the fistula. Then the skin will be dried and disinfected and needle inserted in fistula. The intensity of stress and vital signs before injection and the intensity of pain and vital signs after injection will be evaluated and recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: After every intervention and before the fistula needle. Method of measurement: Stress visual analogue scale.</prim_outcome>
      <prim_outcome>Pain. Timepoint: After every intervention and mmediately after the fistula needle. Method of measurement: Visual analoug scale.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: After every intervention and before and after the fistula needle. Method of measurement: Stigno monometer.</prim_outcome>
      <prim_outcome>Pulse. Timepoint: After every intervention before and after the fistula. Method of measurement: Analog clock with seconds.</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>Vice Chancellor for research; Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-12</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Central building of Shahroud university of medical sciences ,Hafte Tir Square, Shahroud Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
