<?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>IRCT20180429039463N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-28</date_registration>
      <primary_sponsor>Torbate-Heidaria University of Medical Sciences</primary_sponsor>
      <public_title>The effect of virtual reality on pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of virtual reality on pain caused by needle insertion into venous arterial fistula in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62248</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Dividing people into two groups randomly will be used by the random permutation block method. In this way, using blocks with two treatments and a table of random numbers, individuals were assigned to two groups of control and intervention. Then, the personal information questionnaire in both intervention and control groups is completed through interviews. This questionnaire includes information about personal characteristics and medical records (age, sex, type of disease, etc.), Blinding description: In this study, participants and outcome assessors did not know whether participants were in the control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic renal failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, the pain measurement will be measured with virtual reality in such a way that the pain measurement questionnaire is filled by the patient and then the distraction technique will be used once by the Shineken 4 virtual reality headset. First, the patient will be explained about the intervention method, then a list of 5 360-degree videos with nature content and at least 5 minutes will be provided to the patient to be selected to play a video. After selecting the desired video, the smartphone is placed inside the headset and the selected video is played through the virtual reality application. Prior to headset placement, VAS pain intensity and pain quality will be measured and recorded in a short, modified form of the McGill Questionnaire. From 5 minutes before the needle enters the venous arterial fistula, the headset is placed for the patient and the video will be played. At the end of the fifth minute, the nurse inserted the needle into the venous arterial fistula according to the standard method, and after the needle was fixed to the fistula, the video player stopped and the glasses were removed from the patient's eye. The severity of pain is measured and recorded immediately and 15 minutes after insertion of the needle into the fistula and the quality of pain 15 minutes after insertion of the needle into the fistula. Intervention 2: Control group: In the control group, without the patient realizing that routine care was performed and no other intervention was performed, the pain intensity and quality of pain will be measured at the same time intervals as the intervention group using the mentioned scales.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information about the main consequence after being unidentified will be shared

When:
Start the access period 6 months after Publish results

To whom:
Everyone

Conditions:
The results obtained in this study can be used without restriction by researchers.

Where to obtain:
Referring to Torbat Heidarieh Nursing and Midwifery Faculty

How to obtain:
After sending the email to the person responsible for the response process begins.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Namazinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St</address>
        <city>Torbat Heydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>95169-33787</zip>
        <telephone>+98 51 5222 6013</telephone>
        <email>mnamazi99@gmail.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Namazinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St</address>
        <city>Torbat Heydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>95169-33787</zip>
        <telephone>+98 51 5222 6013</telephone>
        <email>mnamazi99@gmail.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have informed consent to participate in all study sessions.
Hemodialysis sessions should be three times a week.
Have vascular access to venous arterial fistulas.
The minimum time for hemodialysis through a fistula is 6 months.
Be 18-70 years old.
Be aware of time, place and person.
Fluency in verbal communication in Persian.
Absence of underlying disease (neuropathy, Guillain-Barre, MS, etc.) that affects pain and pain perception.
No fever more than 37.5 degrees oral
Do not take oral or topical analgesics or sedatives less than 6 hours before hemodialysis
Do not take psychotropic drugs in the 24 hours before hemodialysis
Absence of skin disorders at the injection site
Absence of vision problems and impaired myopia (30 cm or less)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue cooperation
Take painkillers or sedatives in more than two consecutive sessions
Taking psychotropic drugs in the previous 24 hours
Try to get a vein or needle more than twice in each vascular pathway
Fistula failure
Absence of the patient in two or more consecutive sessions
Existence of hearing problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>chronic renal failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, the pain measurement will be measured with virtual reality in such a way that the pain measurement questionnaire is filled by the patient and then the distraction technique will be used once by the Shineken 4 virtual reality headset. First, the patient will be explained about the intervention method, then a list of 5 360-degree videos with nature content and at least 5 minutes will be provided to the patient to be selected to play a video. After selecting the desired video, the smartphone is placed inside the headset and the selected video is played through the virtual reality application. Prior to headset placement, VAS pain intensity and pain quality will be measured and recorded in a short, modified form of the McGill Questionnaire. From 5 minutes before the needle enters the venous arterial fistula, the headset is placed for the patient and the video will be played. At the end of the fifth minute, the nurse inserted the needle into the venous arterial fistula according to the standard method, and after the needle was fixed to the fistula, the video player stopped and the glasses were removed from the patient's eye. The severity of pain is measured and recorded immediately and 15 minutes after insertion of the needle into the fistula and the quality of pain 15 minutes after insertion of the needle into the fistula.</i_keyword>
      <i_keyword>Control group: In the control group, without the patient realizing that routine care was performed and no other intervention was performed, the pain intensity and quality of pain will be measured at the same time intervals as the intervention group using the mentioned scales.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pain intensity is measured and recorded immediately, 15 minutes after the needle is inserted into the fistula, and pain quality is recorded and recorded 15 minutes after the needle is inserted into the fistula. Method of measurement: Pain intensity scale (VAS) and pain quality will be measured and recorded with a short, modified form of the McGill Questionnaire.</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>Torbate-Heidaria University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-27</approval_date>
        <contact_name>Research Ethics Committee of Torbat Heydariyeh University of Medical Sciences</contact_name>
        <contact_address>Torbat Heydariyeh University of Medical Sciences, Razi St., Torbat Heydariyeh, Iran Torbat Heydariyeh Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
