<?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>IRCT20200807048331N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-30</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Virtual Reality on Pain, Anxiety and Satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of using virtual reality and Standard Care on pain intensity, anxiety and satisfaction of emergency patients during suturing</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52620</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using the simple random allocation method, a coin is tossed so that the head side is equivalent to the intervention group and the tail side is equivalent to the control group. This launch is for the first person and the type of group will be determined for it. Then for other people, it continues as one among the type of group and based on the sample size, this allocation continues, and thus, the type of group for each person will be determined randomly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Open wound of ankle, foot and toes. Condition 2: Open wound of knee and lower leg. Condition 3: Open wound of hip and thigh. Condition 4: Open wound of wrist, hand and fingers. Condition 5: Open wound of elbow and forearm. Condition 6: Open wound of shoulder and upper arm. Condition 7: Open wound of abdomen, lower back, pelvis. Condition 8: Open wound of thorax.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  In the intervention group, in addition to routine care, a virtual reality headset will be used from one minute before the start of the procedure to 10 seconds after the end of the procedure. In this way, the headset will fit the patient on the head, so that the eyes are covered with camera lenses and the ears with audio players. The researcher will explain to the patient how to work with this system before using the virtual reality headset. Intervention 2: Control group: The control group will not receive any of the above interventions and will only benefit from the routine and standard care applied in the emergency department of Imam Reza Hospital in Birjand, which includes only local anesthesia with 2% lidocaine. Be.</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 on the main outcome will be available

When:
Access starts the results are published

To whom:
Researchers

Conditions:
.

Where to obtain:
alisheikhalishahi95@gmail.com
m.nassirizadeh@yahoo.com

How to obtain:
.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Sheikhalishahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghafari St.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 35 3722 0539</telephone>
        <email>alisheikhalishahi95@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Manizhe Nasirizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghafari St.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3238 1445</telephone>
        <email>m.nassirizadeh@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient satisfaction
Age 18 to 60 years old
A wound or laceration needs to be sutured according to the doctor's priscription.
The wound is on the trunk or limbs
No fractures or other accompanying injuries
The wound or tear should only include the skin layer.
No injury to fascia, muscle and underlying tissues at the site of rupture (according to the doctor)
The size of the injury should be about 5 to 10 cm.
The patient has visual health.
The patient has hearing health.
The patient should not be addicted to drugs.
Patients do not suffer from dementia or Alzheimer's
Patients do not get motion sickness and stroke
Patients do not have seizures and epilepsy
Having the ability to speak and communicate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to cooperate or participate in the study
The site of the wound or laceration is on the head, face or neck
Phobias of the forest and other images used in virtual reality</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S91</hc_code>
      <hc_code>S81</hc_code>
      <hc_code>S71</hc_code>
      <hc_code>S61</hc_code>
      <hc_code>S51</hc_code>
      <hc_code>S41</hc_code>
      <hc_code>S31</hc_code>
      <hc_code>S21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Open wound of ankle, foot and toes</hc_keyword>
      <hc_keyword>Open wound of knee and lower leg</hc_keyword>
      <hc_keyword>Open wound of hip and thigh</hc_keyword>
      <hc_keyword>Open wound of wrist, hand and fingers</hc_keyword>
      <hc_keyword>Open wound of elbow and forearm</hc_keyword>
      <hc_keyword>Open wound of shoulder and upper arm</hc_keyword>
      <hc_keyword>Open wound of abdomen, lower back, pelvis and external genitals</hc_keyword>
      <hc_keyword>Open wound of thorax</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  In the intervention group, in addition to routine care, a virtual reality headset will be used from one minute before the start of the procedure to 10 seconds after the end of the procedure. In this way, the headset will fit the patient on the head, so that the eyes are covered with camera lenses and the ears with audio players. The researcher will explain to the patient how to work with this system before using the virtual reality headset.</i_keyword>
      <i_keyword>Control group: The control group will not receive any of the above interventions and will only benefit from the routine and standard care applied in the emergency department of Imam Reza Hospital in Birjand, which includes only local anesthesia with 2% lidocaine. Be.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: Before the intervention, during the intervention and after the end of the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention, during the intervention and after the end of the intervention. Method of measurement: Anxiety Linear Scale.</prim_outcome>
      <prim_outcome>Satisfaction. Timepoint: After the end of the intervention. Method of measurement: Satisfaction linear 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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-21</approval_date>
        <contact_name>Ethics committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology, Birjand University of Medical Sciences, Ghafari Street Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
