<?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>IRCT20180412039277N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-07</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of  Mirror Reflection Visual Illusion on Pain</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Various Mirror Reflection Visual Illusion on Pain Intensity due to Needle Insertion in Arterio-Venous Fistula Hemodialysis Patient's</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30553</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The pain caused by the insertion of fistula needles in hemodialysis patients.</hc_freetext>
      <i_freetext>Control session (first sampling session): Needle entry to the fistula is performed by the nurse of the hemodialysis unit without any intervention. Intervention sessions (second and third sampling sessions): The hospital bed's nightstand will be placed in front of the patient. We ask the patient to put his both hands on the table. The mirror of that session, which has been randomly selected for that session in advance, will be placed between the patient's hands at a distance of 30 cm from the forefinger of each hand, so that the healthy hand will be in front of the mirror and the hand with the fistula will be behind the mirror. We ask the patient to look at the picture of his healthy hand in the mirror. Immediately, the needle is inserted into the fistula of the hand behind the mirror by the nurse of the hemodialysis unit. Intervention sessions (fourth and fifth sampling sessions): The hospital bed's nightstand will be placed in front of the patient. We ask the patient to put both hands on the table. The mirror of that session, which has been randomly selected for that session in advance, is placed between the patient's hands at a distance of 30 cm from the forefinger of each hand, so that the healthy hand is in front of the mirror and the hand with the fistula is behind the mirror. We ask the patient to look at the picture of his healthy hand in the mirror for ten minutes. After ten minutes, the needle is inserted into the fistula of the hand behind the mirror by the nurse of the hemodialysis unit..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is I do not want to explain more</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Rajabzadeh Malayjerdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Ebne Sina Street,</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>rajabzadehmz1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Rajabzadeh Malayjerdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Ebne Sina Street,</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>rajabzadehmz1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having informed Consent to Participate in all Study Sessions
Hemodialysis Sessions should be three times a Week
Vascular Access to the Arterial Venous Fistula
Passing at least 6 Months from Hemodialysis via current Fistula
Being able to Speak and Understand Persian
Orientation to time, place and person</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Visual Impairment and Disturbed Close Vision (30 cm or less)
Skin Disorders at the Injection Site (Wound, Sensitivity, Redness, Secretion)
using oral, topical or sedative drugs during 6 hours before Hemodialysis
using Psychoactive Drugs 24 hours before Hemodialysis
Fever Greater than 37.5 Celsius Degrees</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control session (first sampling session): Needle entry to the fistula is performed by the nurse of the hemodialysis unit without any intervention. Intervention sessions (second and third sampling sessions): The hospital bed's nightstand will be placed in front of the patient. We ask the patient to put his both hands on the table. The mirror of that session, which has been randomly selected for that session in advance, will be placed between the patient's hands at a distance of 30 cm from the forefinger of each hand, so that the healthy hand will be in front of the mirror and the hand with the fistula will be behind the mirror. We ask the patient to look at the picture of his healthy hand in the mirror. Immediately, the needle is inserted into the fistula of the hand behind the mirror by the nurse of the hemodialysis unit. Intervention sessions (fourth and fifth sampling sessions): The hospital bed's nightstand will be placed in front of the patient. We ask the patient to put both hands on the table. The mirror of that session, which has been randomly selected for that session in advance, is placed between the patient's hands at a distance of 30 cm from the forefinger of each hand, so that the healthy hand is in front of the mirror and the hand with the fistula is behind the mirror. We ask the patient to look at the picture of his healthy hand in the mirror for ten minutes. After ten minutes, the needle is inserted into the fistula of the hand behind the mirror by the nurse of the hemodialysis unit.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: During the 5 sessions of hemodialysis (control and intervention sessions) immediately after the needle is inserted into the fistula. Method of measurement: Pain Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of visual illusion. Timepoint: During the 4 sessions of hemodialysis (intervention sessions), immediately after the needle is inserted into the fistula. Method of measurement: Longo Questionnaire.</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>2018-04-07</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Quraishi Building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
