<?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>IRCT20101130005280N40</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-25</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of virtual reality on acrophobia treatment</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of virtual reality in acrophobia treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57537</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Acrophobia.</hc_freetext>
      <i_freetext>Intervention group: After diagnosis of acrophobia by a psychiatrist, male and female patients are treated with a virtual reality technique using the software produced by Daj-scientific Corporation for eight 45-minute sessions once a week for 8 weeks. Before the treatment, on session 4, and at the end of the treatment, the State-Trait Anxiety Inventory (STAI) will be administered. The topics covered in each session are as follows. Session 1: getting familiar with the goals and rules of treatment sessions, teaching relaxation techniques, showing photos taken from high locations. Session 2: showing videos of a glass elevator as if the patient is sitting in it and it is at the ground floor and teaching patients relaxation techniques such as breathing techniques. Sessions 3 to 7: showing videos of a glass elevator in which the person is sitting and it goes up to the upper floors of high-rise buildings. In each session according to the progress of treatment, the elevator goes higher and the patient is asked to look at the surroundings and look down and then the patient returns to the ground. Patients are taught relaxations techniques in each session.  From the fourth or fifth session onwards, exercises at home such as going to the elevator, or different heights such as the first floor of the building, etc. are given to evaluate the treatment. Session 8: Combining the extremist forms of all the steps performed in the last 7 sessions, and calming the patient..</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:
All data can be shared after patients are made unidentifiable.

When:
Data can be accessible 6 months after results are published.

To whom:
Data will be available for researchers in universities and other scientific institutes.

Conditions:
Carrying out analysis on data is permitted.

Where to obtain:
Data can be accessible through an email to the corresponding author (Dr Sahar Saadat. Email:saadats961@mums.ac.ir).

How to obtain:
After sending a request email to the corresponding author, data will be sent in 1 month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Saadat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91959 83134</zip>
        <telephone>+98 51 3711 2709</telephone>
        <email>sadats961@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Talaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9195983134</zip>
        <telephone>+98 51 3711 2721</telephone>
        <email>talaeia@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have acrophobia according to the diagnostic interview based on the checklist of symptoms in DSM-5
Patients have symptoms of acrophobia for at least the past six months.
Patients arebetween 18 to 65 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Addiction to alcohol or drugs
Major psychological disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.241</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acrophobia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After diagnosis of acrophobia by a psychiatrist, male and female patients are treated with a virtual reality technique using the software produced by Daj-scientific Corporation for eight 45-minute sessions once a week for 8 weeks. Before the treatment, on session 4, and at the end of the treatment, the State-Trait Anxiety Inventory (STAI) will be administered. The topics covered in each session are as follows. Session 1: getting familiar with the goals and rules of treatment sessions, teaching relaxation techniques, showing photos taken from high locations. Session 2: showing videos of a glass elevator as if the patient is sitting in it and it is at the ground floor and teaching patients relaxation techniques such as breathing techniques. Sessions 3 to 7: showing videos of a glass elevator in which the person is sitting and it goes up to the upper floors of high-rise buildings. In each session according to the progress of treatment, the elevator goes higher and the patient is asked to look at the surroundings and look down and then the patient returns to the ground. Patients are taught relaxations techniques in each session.  From the fourth or fifth session onwards, exercises at home such as going to the elevator, or different heights such as the first floor of the building, etc. are given to evaluate the treatment. Session 8: Combining the extremist forms of all the steps performed in the last 7 sessions, and calming the patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety level. Timepoint: At the beginning of the intervention, week 4 , and at the end of the intervention. Method of measurement: The State-Trait Anxiety Inventory (STAI).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-08</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah street, Ghoreishi building Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
