<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04491149</url>
  </required_header>
  <id_info>
    <org_study_id>#0182-19</org_study_id>
    <nct_id>NCT04491149</nct_id>
  </id_info>
  <brief_title>Study on the Ability of Virtual Reality Glasses in Anxiety and Pain Reduction in 50 Women Undergoing Amniocentesis or Feticide</brief_title>
  <official_title>The Ability of Virtual Reality in Anxiety and Pain Reduction in Women Undergoing Amniocentesis or Feticide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assaf-Harofeh Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Both amniocenteses and especially feticide are procedures that incorporate both anxiety and&#xD;
      pain. As anxiety and pain can be reduced when using a distraction, The investigators&#xD;
      speculate that the use of virtual reality glasses during these procedures will elevate both&#xD;
      anxiety and pain.&#xD;
&#xD;
      The investigators will examine this hypothesis by comparing two groups of participants who&#xD;
      undergo amniocentesis or feticide, one group will undergo the procedure while using virtual&#xD;
      reality glasses and the other without the use of the glasses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety level</measure>
    <time_frame>Up to one hour before the procedure</time_frame>
    <description>Spielberger's State-Trait Anxiety Inventory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety level</measure>
    <time_frame>Up to one hour after the procedure</time_frame>
    <description>Spielberger's State-Trait Anxiety Inventory</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Anxiety Acute</condition>
  <condition>Amniocentesis</condition>
  <condition>Foeticide</condition>
  <arm_group>
    <arm_group_label>women using virtual glass during amniocentesis/foeticide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>women undergoing amniocentesis/foeticide</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>virtual reality glasses</intervention_name>
    <description>In the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure.</description>
    <arm_group_label>women using virtual glass during amniocentesis/foeticide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Pregnant women undergoing amniocentesis/foeticide who will sign an&#xD;
        informed consent form&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women younger than 18 years&#xD;
&#xD;
          -  Twin pregnancies&#xD;
&#xD;
          -  Women with vertigo&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ran Svirsky, MD</last_name>
    <phone>972-89779000</phone>
    <email>rsvirs@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Asaf ha Rofeh, MC</name>
      <address>
        <city>Zrifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ran Svirsky, Doctor of Medicine</last_name>
      <phone>+9729779000</phone>
      <email>rsvirs@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Ran Svirsky, Doctor of Medicine</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>October 26, 2020</last_update_submitted>
  <last_update_submitted_qc>October 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04491149
org study id: #0182-19
nct id: NCT04491149
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Both amniocenteses and especially feticide are procedures that incorporate both anxiety and
      pain. As anxiety and pain can be reduced when using a distraction, The investigators
      speculate that the use of virtual reality glasses during these procedures will elevate both
      anxiety and pain.

      The investigators will examine this hypothesis by comparing two groups of participants who
      undergo amniocentesis or feticide, one group will undergo the procedure while using virtual
      reality glasses and the other without the use of the glasses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Anxiety level
time frame: Up to one hour before the procedure
description: Spielberger's State-Trait Anxiety Inventory
measure: Anxiety level
time frame: Up to one hour after the procedure
description: Spielberger's State-Trait Anxiety Inventory
arm group label: women using virtual glass during amniocentesis/foeticide
arm group type: Experimental
arm group label: women undergoing amniocentesis/foeticide
arm group type: No Intervention
intervention type: Device
intervention name: virtual reality glasses
description: In the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure.
arm group label: women using virtual glass during amniocentesis/foeticide
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ran Svirsky, MD
phone: 972-89779000
email: rsvirs@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Anxiety Disorders