<?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>IRCT20171219037966N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-13</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of two virtual reality methods and guided visualization on intravenous cannulation pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Distraction on two methods of virtual reality and guided visualization on pain caused by venous cannulation in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30712</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Other design features: Due to intervention and outcome evaluation, the researcher, investigator and analyst assistant does not know the type of intervention performed during the sessions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic renal failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group number 1: After receiving informed consent from the patient, the demographic questionnaire is filled in half an hour before the intervention. Then, 25 minutes before hemodialysis, the patients are in supine position, then a few deep abdominal cavities and a diaphragm with closed eyes and comfortable in the best condition in which it relaxes. By providing a quiet, quiet environment and by minimizing environmental stimuli (such as low-light room, walking limits) into an audio file and focusing on the visualization of an illustration, a desirable scenario of listening to the stage-by-stage relaxation of the limbs will be listened without any muscle movement. Audio file The content of mental imagery is played back for 20 minutes, taking into account the sound level between 21 and 10 dB (calibrated by the audiometric expert) so that the person who narrates the text's speaker in the visualization state of the image is in the desired desirable landscape. Then the data will be collected by the researcher's assistant  when the file passes for 15 minutes (5 minutes to complete the audio). During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign. Intervention 2: Intervention group number 2: In the virtual reality group, 10 minutes before the dialysis, special glasses are placed on the head of the patient and they spend 20 minutes spelling pictures designed to reduce pain. After 15 minutes of playing the file, during the watch, the fistula placement and the pain score will be measured by the researcher's assistant. During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.</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 In the process of sampling</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirreza Nasirzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>nasirzadeh@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Farzin Mircheraghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>Mircheraghi.sf@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 18 to 60 years
Awareness of time, place and persons at the time of data collection
Minimal the reading and writing skills</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of mental illness
diabetic neuropathy
patient unwillingness to continue the study
continues use of analgesics 24 hours before hemodialysis
usevof alcohol and drugs
damaged skin in the intended position</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group number 1: After receiving informed consent from the patient, the demographic questionnaire is filled in half an hour before the intervention. Then, 25 minutes before hemodialysis, the patients are in supine position, then a few deep abdominal cavities and a diaphragm with closed eyes and comfortable in the best condition in which it relaxes. By providing a quiet, quiet environment and by minimizing environmental stimuli (such as low-light room, walking limits) into an audio file and focusing on the visualization of an illustration, a desirable scenario of listening to the stage-by-stage relaxation of the limbs will be listened without any muscle movement. Audio file The content of mental imagery is played back for 20 minutes, taking into account the sound level between 21 and 10 dB (calibrated by the audiometric expert) so that the person who narrates the text's speaker in the visualization state of the image is in the desired desirable landscape. Then the data will be collected by the researcher's assistant  when the file passes for 15 minutes (5 minutes to complete the audio). During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.</i_keyword>
      <i_keyword>Intervention group number 2: In the virtual reality group, 10 minutes before the dialysis, special glasses are placed on the head of the patient and they spend 20 minutes spelling pictures designed to reduce pain. After 15 minutes of playing the file, during the watch, the fistula placement and the pain score will be measured by the researcher's assistant. During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: The beginning of the study; the first intervention session and 2, 9 and 11 days after the first intervention. Method of measurement: Visual Analogue Scale.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-12</approval_date>
        <contact_name>Ethics Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Asian Roadside Border Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
