<?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>IRCT20210213050343N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-12</date_registration>
      <primary_sponsor>Persian Gulf University</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Virtual Reality Exposure Therapy with Eye Movement Desensitization and Reprocessing Therapy on Symptoms of Acrophobia and Anxiety Sensitivity</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Virtual Reality Exposure Therapy with Eye Movement Desensitization and Reprocessing Therapy on Symptoms of Acrophobia and Anxiety Sensitivity in Adolescent Girls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57391</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: All patients who give consent for participation and who fulfilling the inclusion criteria are randomized using a random number table. In the random number table, a special code was assigned to each patient, respectively. To randomly assign each patient to the groups, the researcher randomly selected individuals from a table point in a row or direction: VRE (n=15), EMDR therapy (n=15), and the waiting list control condition (n=15), Blinding description: This study is a single-blind study in that the researcher and participants are aware of the allocating intervention, but the data analyst and the person conducting the assessments are blind to the specific participant’s group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fear of Heights or Acrophobia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: VRET is conducte by using a Desktop Computer with specifications; Graphics Card: ASUS NVIDIA GEFORCE GTX 1060 6GB GDDR5, CPU: Core i7-4790 (8M Cache, up to 4.00 GHz), RAM: 8 GB DDR4, and an Oculus Rift Dk2 Virtual Reality Headset. These tools make it possible to create a virtual environment and to provide the VR stimuli to the patient in a safe environment. Patients in the VRET condition are confronte with one VR scenario in each session. In the final session, all VR scenarios are presente one after another. VRET intervention in each session include two consecutive phases: a training phase and an experimental phase. Intervention 2: Intervention group: EMDR therapy in the present study IS based on the standard protocol for specific phobias, consisting of eight steps perform over six one-hour sessions. Intervention 3: Control group: They are assessed one week before the start of treatment and one week after the end of the last treatment session using acrophobia and anxiety sensitivity questionnaires.</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:
Data from participants' responses to acrophobia and anxiety sensitivity questionnaires in pre-test and post-test were analyzed using SPSS software, and the results, without mentioning the names of the participants, were shared as study results.

When:
The access period starts 6 months after the results are published.

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

Conditions:
The data of this study will be provided for use by researchers in review or comparative studies.

Where to obtain:
Parisa Azimisefat
Department of Psychology, Persian Gulf University, Bushehr, Iran.
parisa0730@gmail.com or parisa.azimi@mehr.pgu.ac.ir
+989184025128

How to obtain:
The applicant provides information about their application via email. Up to two weeks after the request, if accepted, documents or data files will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Azimisefat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Persian Gulf Street, Persian Gulf University</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7516913817</zip>
        <telephone>+98 77 3122 2710</telephone>
        <email>parisa0730@gmail.com</email>
        <affiliation>Persian Gulf University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soran Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Persian Gulf Street, Persian Gulf University</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7516913817</zip>
        <telephone>+98 77 3122 2710</telephone>
        <email>sooranrajabi@pgu.ac.ir</email>
        <affiliation>Persian Gulf University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A score greater than or equal to 50 in the Acrophobia Questionnaire
fulfillment of all specific phobia diagnostic criteria (eg, acrophobia) based on SCID-5
submission of written consent for participation in the study by participants and their parents
Age 14 to 18 years</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>patients with hearing or visual impairment such as stereoscopy blindness or nystagmus
presence of any other mental disorders as assessed using the structured clinical interview
presence of specific physiological illnesses such as heart, lung and respiratory diseases, epilepsy and seizures
developmental or intellectual disability, cognitive impairment, known balance disorders such as vertigo, dependent on alcohol or drugs
other current psychological treatment</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>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: VRET is conducte by using a Desktop Computer with specifications; Graphics Card: ASUS NVIDIA GEFORCE GTX 1060 6GB GDDR5, CPU: Core i7-4790 (8M Cache, up to 4.00 GHz), RAM: 8 GB DDR4, and an Oculus Rift Dk2 Virtual Reality Headset. These tools make it possible to create a virtual environment and to provide the VR stimuli to the patient in a safe environment. Patients in the VRET condition are confronte with one VR scenario in each session. In the final session, all VR scenarios are presente one after another. VRET intervention in each session include two consecutive phases: a training phase and an experimental phase.</i_keyword>
      <i_keyword>Intervention group: EMDR therapy in the present study IS based on the standard protocol for specific phobias, consisting of eight steps perform over six one-hour sessions.</i_keyword>
      <i_keyword>Control group: They are assessed one week before the start of treatment and one week after the end of the last treatment session using acrophobia and anxiety sensitivity questionnaires.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Acrophobia: Severe anxiety when standing in high places or watching other people in such situations causes severe fear in people with a phobia. As in other fears, one is fully aware of the irrationality and irrationality of one's fears but nevertheless cannot overcome them. These people try to avoid facing such situations, so that avoidance may have a negative impact on their personal or social life.Anxiety Sensitivity: It is a structure of individual differences in which the individual is afraid of the physical symptoms associated with anxiety arousal (increased heart rate, shortness of breath, dizziness) and basically arises from the belief that these symptoms have potentially harmful consequences. Social, cognitive, and physical leads. Timepoint: One week before the intervention and one week after the last intervention session. Method of measurement: Acrophobia Questionnaire and Anxiety Sensitivity Questionnaire.</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>Persian Gulf University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-19</approval_date>
        <contact_name>Research Ethics Committees of Bushehr Province University of Medical Sciences</contact_name>
        <contact_address>Bushehr, Moallem St., in front of Friday prayer place, Bushehr University of Medical Sciences and Health Services Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
