<?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>IRCT20140515017693N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-03</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Virtual Reality Distraction on Patient's Anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Virtual Reality Distraction on Patient's Anxiety Before Coronary Angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36809</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be performed with daily simple random sampling method. First, on a piece of paper, the name of the "intervention group", and on an another one, the name of the "control group" will be written, and placed in a bowl. Then one of the colleagues who do not have a role in sampling will randomly draw a paper. Whatever the result, the first day of sampling will be assigned to that group; then the next day, the sampling will be assigned to the other group. In other words, in one day, samples of the intervention group, and the next day the control group will be collected. Each groups, which reach earlier to 40, sampling for the other group will continue in the same way at one-day intervals to complete the sampling process for that group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety in candidates for coronary angiography.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention involves the implementation of virtual reality on mobile phone for intervention group. In the control group, virtual reality will not be implemented. To create virtual reality in the intervention group, we will use a virtual reality headset, a mobile phone and headphones to play the sound. A video via a mobile phone will be played that can change the viewing angle of 360 degrees while changing the patient's head position. Its contents include relaxing landscapes such as nature, beach, sea, etc. The video will be played by mobile phone, before transporting the patient to the Cardiac Angiography Suite. Sounds include soft music, birds singing and the sound of the waterfall. The duration of this video will be 5 minutes. Intervention 2: Control group: In the control group, virtual reality will not be implemented. The equivalent time playing virtual reality for the intervention group will be present in the control group. The researcher will be next to the participant and no action will be taken.</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:
The table of final results of the variables in data form and after statistical analysis is sharable without the individual information of each sample.

When:
Reachable in 2019

To whom:
Researchers and students in academic and scientific institutions, people working in the industry

Conditions:
A variety of statistical analyzes will be allowed on data.

Where to obtain:
Guilan University of medical Sciences, Vice chancellor for research
Corresponding author: Mohammad Reza Yeganeh
Address: Faculty of Nursing &amp; Midwifery, Daneshjou St., Martyr Beheshti Boulevard, Rasht
+981333555058
info@gums.ac.ir

How to obtain:
After submitting the application, the application is examined at the research council and the individual can access the data for a maximum of two months.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Yeganeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, Guilan University of Medical Sciences, Daneshjoo St., Shahid Beheshti A</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>416351873</zip>
        <telephone>+98 13 1555 5056</telephone>
        <email>yeganeh@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Yeganeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, Guilan University of Medical Sciences, Daneshjoo St., Shahid Beheshti Ave., Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41469-39814</zip>
        <telephone>+98 13 1555 5056</telephone>
        <email>yeganeh@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients aged 40 to 60 years old candidated for angiography</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of Angiography
Motion Sickness
Intense Hearing and Visual Disability
Psychiatric Diseases</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>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention involves the implementation of virtual reality on mobile phone for intervention group. In the control group, virtual reality will not be implemented. To create virtual reality in the intervention group, we will use a virtual reality headset, a mobile phone and headphones to play the sound. A video via a mobile phone will be played that can change the viewing angle of 360 degrees while changing the patient's head position. Its contents include relaxing landscapes such as nature, beach, sea, etc. The video will be played by mobile phone, before transporting the patient to the Cardiac Angiography Suite. Sounds include soft music, birds singing and the sound of the waterfall. The duration of this video will be 5 minutes.</i_keyword>
      <i_keyword>Control group: In the control group, virtual reality will not be implemented. The equivalent time playing virtual reality for the intervention group will be present in the control group. The researcher will be next to the participant and no action will be taken.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety Scale in Short Version of the Spielberger's Anxiety Measurement Scale. Timepoint: Measuring anxiety score before and after intervention. Method of measurement: Short Version of the Spielberger's Anxiety Measurement Scale.</prim_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: Measuring systolic and diastolic blood pressure before and after intervention. Method of measurement: Aneroid sphygmomanometer.</prim_outcome>
      <prim_outcome>Heart rate in one minute. Timepoint: Counting heart rate in one minute before and after intervention. Method of measurement: A stopwatch of a digital watch.</prim_outcome>
      <prim_outcome>Respiratory rate in one minute. Timepoint: Counting respiratory rate in one minute. Method of measurement: A stopwatch of a digital watch.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-31</approval_date>
        <contact_name>Guilan University of Medical Sciences</contact_name>
        <contact_address>Gillan - Rasht - Namjoo Street - opposite Azodi Stadium - Gilan University of Medical Sciences Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
