<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/NCT02998801</url>
  </required_header>
  <id_info>
    <org_study_id>484-2015</org_study_id>
    <nct_id>NCT02998801</nct_id>
  </id_info>
  <brief_title>Alleviating Pre-operative Anxiety With Innovative 3D Immersive Virtual Reality</brief_title>
  <acronym>VR-Anxiety</acronym>
  <official_title>Alleviating Pre-operative Anxiety With Innovative 3D Immersive Virtual Reality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To construct and evaluate an immersive 3D simulation to familiarize patients with the&#xD;
      pre-operative experience, and investigate whether A) immersive 3D virtual reality video can&#xD;
      reduce pre-operative anxiety, and B) how this approach compares to current practice of&#xD;
      viewing traditional educational videos.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of pre-operative anxiety is estimated as being as high as 80% in surgical&#xD;
      populations. Physiologically, this may result in higher cortisol levels, which may slow down&#xD;
      the healing and recovery process. A multitude of perioperative clinical trials have revealed&#xD;
      that pre-operative anxiety is associated with reduced short-term postoperative recovery,&#xD;
      increased pain scores, nause &amp; vomiting, sleep disturbances, surgical wound infections,&#xD;
      increased length of stay, and cardiac complications. It has also been linked with worse&#xD;
      functional outcomes and quality of life up to one-year after surgery.&#xD;
&#xD;
      Literature looking at factors associated with preoperative anxiety outline a general theme of&#xD;
      the fear of the unknown that is distressing. Specifically, the most distressing events seem&#xD;
      to be waiting to be collected for surgery, waiting outside the operating room (OR), being&#xD;
      transferred to the OR bed and having monitors and oxygen mask applied. These moments prior to&#xD;
      surgery are when patients are most likely to continuously ruminate over 'what comes next' and&#xD;
      the fact of not knowing - leading to anxiety. One survey of 161 patients presenting for&#xD;
      elective surgery inquired about factors that led to being calm prior to their procedure and&#xD;
      found that being well informed of the pre-operative process was a critical aspect of anxiety&#xD;
      relief. Approaches such as implementation of the pre-anesthetic clinic (PAC) and the use of&#xD;
      videos of what to expect leading up to surgery have been implemented to address this issue&#xD;
      but have been costly or have had mixed effects.&#xD;
&#xD;
      Virtual reality (VR) technology presents a new educational opportunity for patients in an&#xD;
      effort to reduce pre-operative anxiety. Through immersive 3D simulation, patients can&#xD;
      experience the journey of being prepped for surgery and transferred to the OR. A patient can&#xD;
      learn about their pre-operative experience in a more engaging manner as opposed to passively&#xD;
      reading, watching video or being verbally taught about it by the healthcare provider. A&#xD;
      patient is educated by having the perception of being physically present in the pre-operative&#xD;
      experience days or weeks prior to their OR date.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">March 20, 2017</completion_date>
  <primary_completion_date type="Actual">March 20, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in anxiety levels as measured using VAS score from baseline to the day of surgery inside the OR.</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Virtual Reality</condition>
  <condition>Anxiety</condition>
  <condition>Preoperative Anxiety</condition>
  <arm_group>
    <arm_group_label>Watch video using IPAD</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient will watch the educational video using an IPAD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Watch video using VR goggles</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will watch the educational video using VR goggles</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IPAD</intervention_name>
    <description>Patients undergoing surgery will watch the video using an PAD</description>
    <arm_group_label>Watch video using IPAD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VR Goggles</intervention_name>
    <description>Patients undergoing surgery will watch the video using goggles</description>
    <arm_group_label>Watch video using VR goggles</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants less than 80 years old presenting to the pre-assessment clinic at&#xD;
             Sunnybrook Health Sciences Centre&#xD;
&#xD;
          -  Planned surgical procedure is 7-14 days after pre-assessment clinic visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Unable to complete study assessments (ie: visually impaired)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fahad Alam, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2017</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02998801
org study id: 484-2015
nct id: NCT02998801
lead sponsor: 
has dmc: No
To construct and evaluate an immersive 3D simulation to familiarize patients with the
      pre-operative experience, and investigate whether A) immersive 3D virtual reality video can
      reduce pre-operative anxiety, and B) how this approach compares to current practice of
      viewing traditional educational videos.
The prevalence of pre-operative anxiety is estimated as being as high as 80% in surgical
      populations. Physiologically, this may result in higher cortisol levels, which may slow down
      the healing and recovery process. A multitude of perioperative clinical trials have revealed
      that pre-operative anxiety is associated with reduced short-term postoperative recovery,
      increased pain scores, nause & vomiting, sleep disturbances, surgical wound infections,
      increased length of stay, and cardiac complications. It has also been linked with worse
      functional outcomes and quality of life up to one-year after surgery.

      Literature looking at factors associated with preoperative anxiety outline a general theme of
      the fear of the unknown that is distressing. Specifically, the most distressing events seem
      to be waiting to be collected for surgery, waiting outside the operating room (OR), being
      transferred to the OR bed and having monitors and oxygen mask applied. These moments prior to
      surgery are when patients are most likely to continuously ruminate over 'what comes next' and
      the fact of not knowing - leading to anxiety. One survey of 161 patients presenting for
      elective surgery inquired about factors that led to being calm prior to their procedure and
      found that being well informed of the pre-operative process was a critical aspect of anxiety
      relief. Approaches such as implementation of the pre-anesthetic clinic (PAC) and the use of
      videos of what to expect leading up to surgery have been implemented to address this issue
      but have been costly or have had mixed effects.

      Virtual reality (VR) technology presents a new educational opportunity for patients in an
      effort to reduce pre-operative anxiety. Through immersive 3D simulation, patients can
      experience the journey of being prepped for surgery and transferred to the OR. A patient can
      learn about their pre-operative experience in a more engaging manner as opposed to passively
      reading, watching video or being verbally taught about it by the healthcare provider. A
      patient is educated by having the perception of being physically present in the pre-operative
      experience days or weeks prior to their OR date.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in anxiety levels as measured using VAS score from baseline to the day of surgery inside the OR.
time frame: 2 weeks
measure: Change in heart rate between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.
time frame: 2 weeks
measure: Change in blood pressure between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.
time frame: 2 weeks
arm group label: Watch video using IPAD
arm group type: Placebo Comparator
description: Patient will watch the educational video using an IPAD
arm group label: Watch video using VR goggles
arm group type: Active Comparator
description: Patient will watch the educational video using VR goggles
intervention type: Other
intervention name: IPAD
description: Patients undergoing surgery will watch the video using an PAD
arm group label: Watch video using IPAD
intervention type: Other
intervention name: VR Goggles
description: Patients undergoing surgery will watch the video using goggles
arm group label: Watch video using VR goggles
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Fahad Alam, MD, FRCPC
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Anxiety Disorders
sharing ipd: Undecided