<?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>IRCT20210612051552N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-29</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of virtual reality and multimedia methods on anxiety and stress</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of two methods of virtual reality and multimedia on the anxiety and stress in companions of patients underlying angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>210</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56842</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The statistical population is randomly divided into 6 groups by triple blocking method. How to arrange the groups as ABC ACB BAC BCA CAB CBA by assigning each letter to each study group. These makeups will be placed inside a container. At each sampling, they will be randomly selected from inside the container and will be placed in a group according to the letter arrangement of each sample with the priority of the letters, Blinding description: In this study, a regular nurse will be used to complete the questionnaires of the subjects who are not aware of the study group and also the data analyzer is not aware of the type of groups of individuals.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stress and anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Virtual reality (people in this group received routine training by a regular nurse the night before the operation and the day of the operation after the patient enters the operating room will be under virtual reality with sedative content for 10 minutes and before The patient will leave the operating room and the questionnaires will be completed.). Intervention 2: Intervention group 2: under multimedia (people in this group received routine training by a regular nurse the night before the operation and the day of the operation after the patient enters the operating room will be under multimedia with sedative content for 10 minutes and before The patient will leave the operating room to complete the questionnaires.). Intervention 3: Control group: Control group: People in this group will receive routine training by a regular nurse the night before the operation and the day of the operation will be without intervention and the questionnaires will be completed before the patient leaves the operating room.</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:
Some data, such as information about the main outcome, can be shared after people are not identified.زمان

When:
The access period starts 1 year after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
Can be requested for academic studies as well as for use in clinical treatment

Where to obtain:
Applicants can apply for documentation by sending an e-mail to the main researcher of the study, Dr. Nasser Mozaffari, at naser.m51@gmail.com

How to obtain:
In order to receive the documents, a written letter must be sent from the place of application as well as the full details of the requesting person or university by email to the main researcher, and after review, it must be answered within 2-3 weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roshanak Eftekhar ardebili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 11.,Sanai Building 2.,Shahid Nosrat Ghorbani Alley.,Enghelab Street.,Aali Qapo Square</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5615793813</zip>
        <telephone>+98 45 3371 9148</telephone>
        <email>r.eftekhar@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roshanak Eftekhar Ardebili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 11.,Sanai Building 2.,Shahid Nosrat Ghorbani Alley.,Enghelab Street.,Aali Qapo Square</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5615793813</zip>
        <telephone>+98 45 3371 9148</telephone>
        <email>r.eftekhar@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>First class patient family
Having conscious satisfaction
Age over 18 and under 60
Families of patients on the operation list the next day</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having effective vision and hearing problems in communication
Join the treatment team
Having neurological illnesses (for at least 6 months) and motion sickness</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Virtual reality (people in this group received routine training by a regular nurse the night before the operation and the day of the operation after the patient enters the operating room will be under virtual reality with sedative content for 10 minutes and before The patient will leave the operating room and the questionnaires will be completed.)</i_keyword>
      <i_keyword>Intervention group 2: under multimedia (people in this group received routine training by a regular nurse the night before the operation and the day of the operation after the patient enters the operating room will be under multimedia with sedative content for 10 minutes and before The patient will leave the operating room to complete the questionnaires.)</i_keyword>
      <i_keyword>Control group: Control group: People in this group will receive routine training by a regular nurse the night before the operation and the day of the operation will be without intervention and the questionnaires will be completed before the patient leaves the operating room.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress score in Harry Stress Questionnaire. Timepoint: The sections of completing the questionnaire are the night before the operation and then tomorrow (the day of the operation) after the intervention with virtual reality and multimedia in the intervention groups before the patient leaves the operating room. Method of measurement: Harry Stress Inventory Standard Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety score in Speilberger Questionnaire. Timepoint: The sections of completing the questionnaire are the night before the operation and then tomorrow (the day of the operation) after the intervention with virtual reality and multimedia in the intervention groups before the patient leaves the operating room. Method of measurement: The State-Trait Anxiety Inventory (Spielberger).</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-23</approval_date>
        <contact_name>Ethics Committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Administrative complex of Ardabil University of Medical Sciences.,End of Daneshgah St. Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
