xml: <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/NCT06029582</url>
    </required_header>
    <id_info>
      <org_study_id>SLIR-2023-55</org_study_id>
      <nct_id>NCT06029582</nct_id>
    </id_info>
    <brief_title>VR Headset for Pain During Pregnancy Termination</brief_title>
    <acronym>VRPASAB</acronym>
    <official_title>The Use of Virtual Reality Headset in Controlling Pain During Pregnancy Termination; a Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>St. Luke's Hospital, Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>St. Luke's Hospital, Pennsylvania</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>
        The goal of this randomized control study is to see if virtual reality headsets (VRHS) are&#xD;
        useful in women undergoing surgical pregnancy termination. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
        Do VRHS decrease the pain associated with surgical pregnancy termination Participants will&#xD;
        wear the VRHS during the surgery and take a pain survey before and after the procedure. The&#xD;
        pain assessment will be compared to placebo headset which will be randomly assigned.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Use of virtual reality headsets have been employed in cancer and behavioral medicine fields&#xD;
        with moderate success in controlling anxiety stress and pain. The decision to terminate a&#xD;
        pregnancy can create significant stress and anxiety. In the US, there are over 900,000&#xD;
        pregnancy terminations each year with many patients undergoing dilation and evacuation with&#xD;
        minimal anesthesia. We plan to assess virtual reality headset's ability to decrease pain&#xD;
        associated with surgical termination of pregnancy.&#xD;
  &#xD;
        Patient's will be recruited from a single outpatient family-planning center. Inclusion&#xD;
        criteria include all patients over the age of 18 that are undergoing a surgical termination&#xD;
        of pregnancy in the first and second trimester under local and/or conscious sedation&#xD;
        anesthesia. Patients under the age of 18 with significant medical comorbidities will be&#xD;
        excluded. Patient demographics including age, BMI, obstetric/ gynecology history, and prior&#xD;
        terminations will be collected. Patients will be given pre- procedure survey to assess&#xD;
        anxiety and stress. The survey will be self-administered with assistance from study&#xD;
        personnel. Patients will then be randomized to either the virtual reality headset or no&#xD;
        headset. The procedure will be then performed with the headsets on the patients. Amount and&#xD;
        type of local anesthesia employed will be recorded. After the procedure (within 1 hour), the&#xD;
        individuals will be resurveyed for both stress and anxiety, with the addition of a visual&#xD;
        analog scale to assessing pain associated with the procedure. Pre and post vital signs will&#xD;
        also be extracted from the chart. The patient as well as the clinician performing the&#xD;
        procedure will be masked as to the intervention. We will require 50 patients per arm assuming&#xD;
        a 30% reduction in the pain scale (power 80%, 95% CI, with SD of 0.70). Logistic regression&#xD;
        will be performed for those comorbidities that may be influence our outcome, such as age,&#xD;
        BMI, prior terminations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 20, 2023</start_date>
    <completion_date type="Anticipated">July 7, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 8, 2024</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain reduction</measure>
      <time_frame>immediately after procedure (10 minutes)</time_frame>
      <description>A pain scale (visual analog scale) will be used to assess reduction of pain (scale 1-10) one being no pain, 10 highest level of pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety reduction</measure>
      <time_frame>pre and post procedure 1 hr before procedure and within 10 minutes after</time_frame>
      <description>A scale will be used to assess anxiety (Visual analog scale: scale 1-10) 1 being no stress, 10 being highest level of stress</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Heart rate variation</measure>
      <time_frame>pre and post procedure, 10 minutes before and 10, 20 minutes after</time_frame>
      <description>Changes in heart rate in beats per minute</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood pressure variation</measure>
      <time_frame>pre and post procedure, 10 minutes before and 10, 20 minutes after</time_frame>
      <description>Changes in blood Pressure (mm/Hg)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Pregnancy Termination</condition>
    <arm_group>
      <arm_group_label>Virtual Reality headset</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals will wear the Virtual Reality Headset that produce a calming scenario</description>
    </arm_group>
    <arm_group>
      <arm_group_label>controls</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>no headset</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>VR headset</intervention_name>
      <description>Virtual Reality Headset</description>
      <arm_group_label>Virtual Reality headset</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  all healthy patients undergoing a first or second trimester pregnancy termination&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy patients requesting a termination under the age of 18&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>James N Anasti, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>St Luke's University Hosptial</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>James N Anasti, MD</last_name>
      <phone>484-526-8878</phone>
      <email>anastij@slhn.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Allentown Women Center</name>
        <address>
          <city>Allentown</city>
          <state>Pennsylvania</state>
          <zip>18015</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>James N Anasti, MD</last_name>
        <phone>610-844-2106</phone>
        <email>anastij@slhn.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029582
  org study id: SLIR-2023-55
  nct id: NCT06029582
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized control study is to see if virtual reality headsets (VRHS) are
        useful in women undergoing surgical pregnancy termination. The main questions it aims to
        answer are:
  
        Do VRHS decrease the pain associated with surgical pregnancy termination Participants will
        wear the VRHS during the surgery and take a pain survey before and after the procedure. The
        pain assessment will be compared to placebo headset which will be randomly assigned.
  Use of virtual reality headsets have been employed in cancer and behavioral medicine fields
        with moderate success in controlling anxiety stress and pain. The decision to terminate a
        pregnancy can create significant stress and anxiety. In the US, there are over 900,000
        pregnancy terminations each year with many patients undergoing dilation and evacuation with
        minimal anesthesia. We plan to assess virtual reality headset's ability to decrease pain
        associated with surgical termination of pregnancy.
  
        Patient's will be recruited from a single outpatient family-planning center. Inclusion
        criteria include all patients over the age of 18 that are undergoing a surgical termination
        of pregnancy in the first and second trimester under local and/or conscious sedation
        anesthesia. Patients under the age of 18 with significant medical comorbidities will be
        excluded. Patient demographics including age, BMI, obstetric/ gynecology history, and prior
        terminations will be collected. Patients will be given pre- procedure survey to assess
        anxiety and stress. The survey will be self-administered with assistance from study
        personnel. Patients will then be randomized to either the virtual reality headset or no
        headset. The procedure will be then performed with the headsets on the patients. Amount and
        type of local anesthesia employed will be recorded. After the procedure (within 1 hour), the
        individuals will be resurveyed for both stress and anxiety, with the addition of a visual
        analog scale to assessing pain associated with the procedure. Pre and post vital signs will
        also be extracted from the chart. The patient as well as the clinician performing the
        procedure will be masked as to the intervention. We will require 50 patients per arm assuming
        a 30% reduction in the pain scale (power 80%, 95% CI, with SD of 0.70). Logistic regression
        will be performed for those comorbidities that may be influence our outcome, such as age,
        BMI, prior terminations.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pain reduction
  time frame: immediately after procedure (10 minutes)
  description: A pain scale (visual analog scale) will be used to assess reduction of pain (scale 1-10) one being no pain, 10 highest level of pain
  measure: Anxiety reduction
  time frame: pre and post procedure 1 hr before procedure and within 10 minutes after
  description: A scale will be used to assess anxiety (Visual analog scale: scale 1-10) 1 being no stress, 10 being highest level of stress
  measure: Heart rate variation
  time frame: pre and post procedure, 10 minutes before and 10, 20 minutes after
  description: Changes in heart rate in beats per minute
  measure: Blood pressure variation
  time frame: pre and post procedure, 10 minutes before and 10, 20 minutes after
  description: Changes in blood Pressure (mm/Hg)
  arm group label: Virtual Reality headset
  arm group type: Experimental
  description: Individuals will wear the Virtual Reality Headset that produce a calming scenario
  arm group label: controls
  arm group type: No Intervention
  description: no headset
  intervention type: Device
  intervention name: VR headset
  description: Virtual Reality Headset
  arm group label: Virtual Reality headset
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: James N Anasti, MD
  role: Principal Investigator
  affiliation: St Luke's University Hosptial
  last name: James N Anasti, MD
  phone: 484-526-8878
  email: anastij@slhn.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No