<?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>IRCT20150724023314N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-28</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Virtual Reality on Vital Signs, Oxygen Saturation of Arterial Blood and Pain of Patients During Outpatient Repair of the Skin Rupture</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Virtual Reality on Vital Signs, Oxygen Saturation of Arterial Blood and Pain of Patients During Outpatient Repair of the Skin Rupture in the Emergency Department of Shahid Beheshti Hospital in Qom</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55179</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: -, Randomization description: Participants will be assigned to intervention and control groups using block randomized method. The link "https://www.sealedenvelope.com/simple-randomiser/v1/lists" will be used for block randomization. For this purpose, the target number of samples (200 samples including sample loss), number of groups (two groups A and B) and number of blocks (4) will be entered and the system will provide the researcher with a list of 4 blocks. Based on the output list, it will be determined in which group the patients who enter the study should be placed in order. Items A represent the intervention group and items B represent the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Skin rupture.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, during the repair of skin rupture, in addition to injecting 3-5 cc of 2% lidocaine ampoule subcutaneously, a film containing natural landscapes will be played to patients for 20 minutes.  VRBOX branded virtual reality headsets will be used for video playback. The intervention will be done only once and during the repair of the skin rupture. Intervention 2: In the control group, 3-5 cc of 2% lidocaine ampoule will be injected subcutaneously immediately before repairing the skin rupture to control the patient's pain.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Abbasinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qom University of Medical Science, Saheli Street, Qom.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713649373</zip>
        <telephone>+98 25 3107 1100</telephone>
        <email>armak1364@yahoo.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Abbasinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qom University of Medical Science, Saheli Street, Qom.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9345637169</zip>
        <telephone>+98 25 3107 1100</telephone>
        <email>armak1364@yahoo.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Having rupture on the upper or lower limbs
No history of hearing or vision disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient refuses to continue participating in the study
Patients who need blood transfusions
Patients who need tendon or artery repair
Concomitant use of other anesthetic methods in addition to lidocaine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T81.33</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disruption of traumatic injury wound repair</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, during the repair of skin rupture, in addition to injecting 3-5 cc of 2% lidocaine ampoule subcutaneously, a film containing natural landscapes will be played to patients for 20 minutes.  VRBOX branded virtual reality headsets will be used for video playback. The intervention will be done only once and during the repair of the skin rupture.</i_keyword>
      <i_keyword>In the control group, 3-5 cc of 2% lidocaine ampoule will be injected subcutaneously immediately before repairing the skin rupture to control the patient's pain.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Immediately before and immediately after repair of the skin rupture. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Immediately before and immediately after repair of the skin rupture. Method of measurement: Vital Sign Monitoring Device.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Immediately before and immediately after repair of the skin rupture. Method of measurement: Vital Sign Monitoring Device.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: Immediately before and immediately after repair of the skin rupture. Method of measurement: Vital Sign Monitoring Device.</sec_outcome>
      <sec_outcome>Arterial blood oxygen saturation. Timepoint: Immediately before and immediately after repair of the skin rupture. Method of measurement: Vital Sign 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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-04</approval_date>
        <contact_name>Ethics committee of Qom University of Medical Sciences</contact_name>
        <contact_address>Qom University of Medical Sciences, Saheli street, Qom Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
