<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/NCT04466956</url>
  </required_header>
  <id_info>
    <org_study_id>271029</org_study_id>
    <nct_id>NCT04466956</nct_id>
  </id_info>
  <brief_title>Virtual Reality in MVA for Miscarriage</brief_title>
  <official_title>Virtual Reality as a Distraction Technique for the Management of Acute Pain and Anxiety During Manual Vacuum Aspiration for Miscarriage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barts &amp; The London NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Middlesex University Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Barts &amp; The London NHS Trust</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>
      We are investigating the use of a virtual reality programme to reduce pain and anxiety&#xD;
      experienced during manual vacuum aspiration.&#xD;
&#xD;
      Virtual reality (VR) is the computer-generated simulation of a three-dimensional environment&#xD;
      that can be interacted with in a seemingly real way by a person using special electronic&#xD;
      equipment. In this study a VR headset is worn by the patient allowing them to experience a&#xD;
      relaxing environment whilst the procedure manual vacuum aspiration (MVA) is performed.&#xD;
&#xD;
      VR is mostly used in computer gaming but has uses in medical field and has been used in the&#xD;
      treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain.&#xD;
      However, its role in the management of pain and anxiety during gynaecological procedures like&#xD;
      manual vacuum aspiration has not been researched. This study explores whether it has a place&#xD;
      in the treatment of gynaecological pain and reduction of anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many simple gynaecological procedures can be performed in an outpatient setting without the&#xD;
      need for general anaesthesia. Such office-based procedures include outpatient hysteroscopy,&#xD;
      endometrial biopsy, large-loop-excision of the transformation zone and manual vacuum&#xD;
      aspiration for the management of miscarriage. Advantages experienced by patients include&#xD;
      reduced anaesthetic risk, enhanced recovery time and flexibility of timings. For the&#xD;
      healthcare provider there are significant cost benefits on the basis of reduced theatre time,&#xD;
      staff and equipment. Patient satisfaction is generally high but influenced by their&#xD;
      experience of pain and feelings of anxiety before, during and after the procedure.&#xD;
&#xD;
      The rationale for this study is to invetsigate the role of distraction techniques and the&#xD;
      feasibility of using virtual reality for the management of acute pain and anxiety experienced&#xD;
      by patients undergoing manual vacuum aspiration&#xD;
&#xD;
      Primary objective&#xD;
&#xD;
      • Feasibility of using virtual reality as a distraction technique in management of acute pain&#xD;
      and anxiety in patients undergoing manual vacuum aspiration for miscarriage.&#xD;
&#xD;
      Secondary objectives&#xD;
&#xD;
        -  Understanding the acceptability and effectiveness of VR interventions in office&#xD;
           gynaecology procedures&#xD;
&#xD;
        -  Understanding the factors that might influence the willingness of patients to&#xD;
           participate in a future formal trial of the technology.&#xD;
&#xD;
        -  Understanding how best to implement the technology and designing of the contents of the&#xD;
           VR intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2021</start_date>
  <completion_date type="Anticipated">January 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</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>
    <intervention_model_description>Intervention 25 and control 25</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety rating</measure>
    <time_frame>12 months</time_frame>
    <description>Anxiety score (numerical rating score 0 least-10 worst) and questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain rating</measure>
    <time_frame>12 months</time_frame>
    <description>Pain score (numerical rating score 0 least-10 worst) and questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Miscarriage</condition>
  <arm_group>
    <arm_group_label>Virtual reality for reduction of pain and anxiety during MVA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group- no VR</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual reality</intervention_name>
    <description>Virtual reality headset worn with short relaxing video played during MVA procedure</description>
    <arm_group_label>Virtual reality for reduction of pain and anxiety during MVA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients: Clinical indications for undergoing an MVA will be confirmed. Inclusion criteria&#xD;
        will include all women of 18 - 50 years of age, planned for a MVA who are able and willing&#xD;
        to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hearing impairments and blindness&#xD;
&#xD;
          -  History of epilepsy or any previous seizures&#xD;
&#xD;
          -  Any known anatomical characteristics that may make performing the office procedure&#xD;
             more difficult (e.g., cervical conisation)&#xD;
&#xD;
          -  Any known characteristics that make the patient unsuitable for undergoing MVA (e.g.&#xD;
             known bleeding disorder, gestation &gt;12 weeks)&#xD;
&#xD;
          -  The denial or withdrawal of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nandita Deo, MRCOG</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barts &amp; The London NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anna A McDougall, MRCOG</last_name>
    <phone>07739846763</phone>
    <email>anna.mcdougall@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nandita Deo, MRCOG</last_name>
    <phone>07939 360357</phone>
    <email>nandita.deo@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Whipps Cross University Hospital</name>
      <address>
        <city>London</city>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nandita Deo, MRCOG</last_name>
      <email>nandita.deo@nhs.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>North Middlesex University Hospital</name>
      <address>
        <city>London</city>
        <zip>N18 1QX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna A McDougall, MRCOG</last_name>
      <phone>07739846763</phone>
      <email>Anna.mcdougall@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>Schahrazed Rouabhi</last_name>
      <email>schahrazed.rouabhi@nhs.net</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Management</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Plan to publish results</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>At completion of study anticipated 2022</ipd_time_frame>
    <ipd_access_criteria>Public</ipd_access_criteria>
  </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/NCT04466956
org study id: 271029
nct id: NCT04466956
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We are investigating the use of a virtual reality programme to reduce pain and anxiety
      experienced during manual vacuum aspiration.

      Virtual reality (VR) is the computer-generated simulation of a three-dimensional environment
      that can be interacted with in a seemingly real way by a person using special electronic
      equipment. In this study a VR headset is worn by the patient allowing them to experience a
      relaxing environment whilst the procedure manual vacuum aspiration (MVA) is performed.

      VR is mostly used in computer gaming but has uses in medical field and has been used in the
      treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain.
      However, its role in the management of pain and anxiety during gynaecological procedures like
      manual vacuum aspiration has not been researched. This study explores whether it has a place
      in the treatment of gynaecological pain and reduction of anxiety.
Many simple gynaecological procedures can be performed in an outpatient setting without the
      need for general anaesthesia. Such office-based procedures include outpatient hysteroscopy,
      endometrial biopsy, large-loop-excision of the transformation zone and manual vacuum
      aspiration for the management of miscarriage. Advantages experienced by patients include
      reduced anaesthetic risk, enhanced recovery time and flexibility of timings. For the
      healthcare provider there are significant cost benefits on the basis of reduced theatre time,
      staff and equipment. Patient satisfaction is generally high but influenced by their
      experience of pain and feelings of anxiety before, during and after the procedure.

      The rationale for this study is to invetsigate the role of distraction techniques and the
      feasibility of using virtual reality for the management of acute pain and anxiety experienced
      by patients undergoing manual vacuum aspiration

      Primary objective

      • Feasibility of using virtual reality as a distraction technique in management of acute pain
      and anxiety in patients undergoing manual vacuum aspiration for miscarriage.

      Secondary objectives

        -  Understanding the acceptability and effectiveness of VR interventions in office
           gynaecology procedures

        -  Understanding the factors that might influence the willingness of patients to
           participate in a future formal trial of the technology.

        -  Understanding how best to implement the technology and designing of the contents of the
           VR intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention 25 and control 25
primary purpose: Treatment
masking: None (Open Label)
measure: Anxiety rating
time frame: 12 months
description: Anxiety score (numerical rating score 0 least-10 worst) and questionnaire
measure: Pain rating
time frame: 12 months
description: Pain score (numerical rating score 0 least-10 worst) and questionnaire
arm group label: Virtual reality for reduction of pain and anxiety during MVA
arm group type: Active Comparator
description: 25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience
arm group label: Control group- no VR
arm group type: No Intervention
description: 25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience
intervention type: Device
intervention name: Virtual reality
description: Virtual reality headset worn with short relaxing video played during MVA procedure
arm group label: Virtual reality for reduction of pain and anxiety during MVA
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nandita Deo, MRCOG
role: Principal Investigator
affiliation: Barts & The London NHS Trust
last name: Anna A McDougall, MRCOG
phone: 07739846763
email: anna.mcdougall@nhs.net
last name: Nandita Deo, MRCOG
phone: 07939 360357
email: nandita.deo@nhs.net
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Abortion, Spontaneous
sharing ipd: Yes
ipd description: Plan to publish results
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: At completion of study anticipated 2022
ipd access criteria: Public