<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/NCT04438759</url>
  </required_header>
  <id_info>
    <org_study_id>HYSVIR</org_study_id>
    <nct_id>NCT04438759</nct_id>
  </id_info>
  <brief_title>Clinical Efficacy of Virtual Reality During Office Hysteroscopy and Endometrial Biopsy in Subfertility</brief_title>
  <acronym>HYSVIR</acronym>
  <official_title>Clinical Efficacy of Virtual Reality for Acute Pain and Anxiety Management During Outpatient Hysteroscopy and Endometrial Biopsy in Subfertility Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a comparison between the current standard practice of performing a diagnostic&#xD;
      hysteroscopy and a relatively recently developed technology that is added to the standard&#xD;
      diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology&#xD;
      has an advantage for the patient, in the form of anxiety and pain reduction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</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>Single Group Assignment</intervention_model>
    <intervention_model_description>This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain experience as assessed using visual analog scale</measure>
    <time_frame>1/ baseline pre-procedure 2/ immediately after the procedure (1+2= day of office hysteroscopy) and 3/ 1 week after the procedure</time_frame>
    <description>quantified through visual analog scale: from 0.0 to 10.0cm, ranging from 0.0 meaning 'No pain' and 10.0 representing 'worst imaginable pain'.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>investigational group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual Reality</description>
  </arm_group>
  <arm_group>
    <arm_group_label>reference group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oncomfort, commercially available Virtual Reality headset</intervention_name>
    <description>Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform 93/42/EEC and 2007/47/EEC</description>
    <arm_group_label>investigational group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing fertility treatments&#xD;
&#xD;
          -  for which outpatient hysteroscopy has been prescribed&#xD;
&#xD;
          -  for different possible indications: suspicion of intracavitary pathology, recurrent&#xD;
             implantation failure, recurrent early pregnancy loss, …&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hearing impairments and blindness&#xD;
&#xD;
          2. Motion sickness&#xD;
&#xD;
          3. Any known anatomical characteristics that may make performing the office procedure&#xD;
             impossible.&#xD;
&#xD;
          4. The unwillingness of the patient to undergo an office hysteroscopy&#xD;
&#xD;
          5. Denial or withdrawal of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>hysteroscopy requires presence of uterus</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>valerie schutyser</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Brussel CRG</name>
      <address>
        <city>Jette</city>
        <state>Brussels</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>February 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>July 8, 2022</last_update_submitted>
  <last_update_submitted_qc>July 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <keyword>hysteroscopy</keyword>
  <keyword>infertility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04438759
org study id: HYSVIR
nct id: NCT04438759
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a comparison between the current standard practice of performing a diagnostic
      hysteroscopy and a relatively recently developed technology that is added to the standard
      diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology
      has an advantage for the patient, in the form of anxiety and pain reduction.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in pain experience as assessed using visual analog scale
time frame: 1/ baseline pre-procedure 2/ immediately after the procedure (1+2= day of office hysteroscopy) and 3/ 1 week after the procedure
description: quantified through visual analog scale: from 0.0 to 10.0cm, ranging from 0.0 meaning 'No pain' and 10.0 representing 'worst imaginable pain'.
arm group label: investigational group
arm group type: Experimental
description: Virtual Reality
arm group label: reference group
arm group type: No Intervention
description: standard of care
intervention type: Device
intervention name: Oncomfort, commercially available Virtual Reality headset
description: Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform 93/42/EEC and 2007/47/EEC
arm group label: investigational group
criteria: 
gender: Female
gender based: Yes
gender description: hysteroscopy requires presence of uterus
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: Accepts Healthy Volunteers
last name: valerie schutyser
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
sharing ipd: No