<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/NCT03037905</url>
  </required_header>
  <id_info>
    <org_study_id>CCF15-009</org_study_id>
    <nct_id>NCT03037905</nct_id>
  </id_info>
  <brief_title>Effect of the Built Operating Room Environment on Patient Outcome</brief_title>
  <official_title>Effect of the Built Operating Room Environment on Patient Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>STERIS Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anxiety prior to surgery is an expected emotion. Research has not been conducted on methods&#xD;
      to reduce anxiety in the operating room itself. STERIS Corporation has developed an automated&#xD;
      surgical suite environmental system, called SignatureSuite™, that controls the level of&#xD;
      lighting, images on OR monitors, and ambient background audio via preset, computerized&#xD;
      automation for use before and after anesthesia. This study aims to determine if this new type&#xD;
      of operating room environment decreases anxiety, as measured by patient responses on anxiety&#xD;
      visual analog scales, heart rate, systolic blood pressure, and postoperative analgesic use.&#xD;
      The proposed study will be a two-arm, randomized controlled trial comparing anxiety levels&#xD;
      for patients that have thyroid or parathyroid surgery in the SignatureSuite room at Cleveland&#xD;
      Clinic Marymount Hospital versus the standard operating room environment. Randomization will&#xD;
      occur at the surgeon level. There will be a maximum 100 patients divided equally between the&#xD;
      experimental and control arms of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Problem: Anxiety prior to surgery is an expected emotion. Research has been conducted on&#xD;
      methods to reduce anxiety prior to entering the operating room (OR). These studies have&#xD;
      involved some form of distraction, almost all finding that some form of distraction prior to&#xD;
      entering the OR decreases both physiologic signs and patient reports of anxiety. Very few of&#xD;
      these studies have carried the intervention into the OR itself. Steris Corporation has&#xD;
      developed an automated surgical suite environmental system, called SignatureSuite™, that&#xD;
      controls the level of lighting, images on OR monitors, and ambient background audio via&#xD;
      preset, computerized automation for use before and after anesthesia. The research question&#xD;
      is: What is the effect of the SignatureSuite OR environment on patient anxiety and analgesic&#xD;
      use? Study methods: The proposed study will be a two arm randomized controlled trial.&#xD;
      Randomization will occur at the surgeon level, based on SignatureSuite operating room&#xD;
      environment (experimental group) versus a standard Marymount Hospital operating room&#xD;
      environment (control group).&#xD;
&#xD;
      Data collection: The study will take place in the perioperative department of Cleveland&#xD;
      Clinic's Marymount Hospital. Patient anxiety will be measured before and after surgery using&#xD;
      an anxiety visual analog scale (VAS). Data about patient characteristics will be retrieved&#xD;
      retrospectively by chart review. The effect of SignatureSuite on OR time will also be&#xD;
      determined.&#xD;
&#xD;
      Sample characteristics: The patient sample will comprise patients undergoing thyroid and/or&#xD;
      parathyroid surgery at Cleveland Clinic Marymount Hospital.&#xD;
&#xD;
      Sample size: 40 subjects per group will provide adequate power to detect large effect sizes&#xD;
      (0.80) and is feasible in a reasonable period of time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Change (Difference) in Anxiety</measure>
    <time_frame>Pre-operatively to post-operatively</time_frame>
    <description>Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety. It is measured on a 100 millimeter line with anchors &quot;No anxiety&quot; to &quot;The most anxiety I can imagine.&quot; Participants make a mark across the line to represent their current state of anxiety. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures</measure>
    <time_frame>Pre-operative to post-operative</time_frame>
    <description>Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates</measure>
    <time_frame>Pre-operative to post-operative</time_frame>
    <description>Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Analgesic Use</measure>
    <time_frame>Postoperatively</time_frame>
    <description>Number of people requiring analgesia in the post-anesthesia care unit</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>SignatureSuite OR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard OR</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SignatureSuite OR Integration System by STERIS Corporation</intervention_name>
    <description>SignatureSuite OR Integration System by STERIS Corporation is a device that controls audio and visual components of the operating room environment in order to provide a more relaxing and calming operating room environment for patients prior to surgery and on emergence from anesthesia after surgery.</description>
    <arm_group_label>SignatureSuite OR</arm_group_label>
    <other_name>SignatureSuite</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  able to read and understand English;&#xD;
&#xD;
          -  presentation for thyroid and/or parathyroid surgery at Marymount Hospital;&#xD;
&#xD;
          -  visual capacity to complete the VAS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of documented anxiety/depression disorder&#xD;
&#xD;
          -  currently taking medications for depression/anxiety&#xD;
&#xD;
          -  currently taking anticonvulsant medication and/or gamma-Aminobutyric acid analogs&#xD;
&#xD;
          -  unable to read and understand English&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  vision loss making it impossible to complete the anxiety visual analog scale&#xD;
&#xD;
          -  currently taking beta-blockers&#xD;
&#xD;
          -  surgeon refusal for patient participation&#xD;
&#xD;
          -  intra-operative emergency, such as cardiac incident requiring resuscitation or&#xD;
             stabilizing medications, unplanned extubation, or early emergence from anesthesia&#xD;
&#xD;
          -  other patient-related reasons that would affect eligibility to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian N Burchill, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Marymount Hospital</name>
      <address>
        <city>Garfield Heights</city>
        <state>Ohio</state>
        <zip>44125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 11, 2016</study_first_submitted>
  <study_first_submitted_qc>September 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <results_first_submitted>September 15, 2017</results_first_submitted>
  <results_first_submitted_qc>October 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 22, 2017</results_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Christian Burchill</investigator_full_name>
    <investigator_title>Nurse Scientist II</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No data to be shared</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SignatureSuite OR</title>
          <description>Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.&#xD;
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.</description>
        </group>
        <group group_id="P2">
          <title>Standard OR</title>
          <description>Patients who's surgeon has been randomized into the standard operating room.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Thyroid surgery cases</population>
      <group_list>
        <group group_id="B1">
          <title>SignatureSuite OR</title>
          <description>Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.&#xD;
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.</description>
        </group>
        <group group_id="B2">
          <title>Standard OR</title>
          <description>Patients who's surgeon has been randomized into the standard operating room.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.7" spread="14.3"/>
                    <measurement group_id="B2" value="53.3" spread="14.3"/>
                    <measurement group_id="B3" value="52.5" spread="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Surgical site</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Parathyroid</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Thyroid</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Kindler Preoperative Anxiety Scale Total Score</title>
          <description>The Kindler preoperative anxiety scale quantifies 10 factors that cause preoperative anxiety. Each factor is measured on a 100 millimeter line with anchors &quot;No anxiety&quot; to &quot;The most anxiety I can imagine.&quot; Participants make a mark across the line to represent their current state on each factor. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety. The average of the scores represents the total preoperative anxiety score.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.8" lower_limit="15.8" upper_limit="55.2"/>
                    <measurement group_id="B2" value="26.6" lower_limit="8.6" upper_limit="44.1"/>
                    <measurement group_id="B3" value="28.9" lower_limit="10.3" upper_limit="47.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Past medical history diagnosis groups</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>cardiovascular/respiratory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>endocrine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gastrointestinal/genitourinary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>neuromuscular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preoperative anxiety visual analog scale</title>
          <description>The preoperative anxiety scale quantifies preoperative anxiety. It is measured on a 100 millimeter line with anchors &quot;No anxiety&quot; to &quot;The most anxiety I can imagine.&quot; Participants make a mark across the line to represent their current state of preoperative anxiety. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.3" spread="27.9"/>
                    <measurement group_id="B2" value="32.0" spread="28.9"/>
                    <measurement group_id="B3" value="34.13" spread="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preoperative systolic blood pressure</title>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="137.50" spread="17.4"/>
                    <measurement group_id="B2" value="142.6" spread="19.8"/>
                    <measurement group_id="B3" value="140.0" spread="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preoperative heart rate</title>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77.9" spread="12.7"/>
                    <measurement group_id="B2" value="78.8" spread="15.3"/>
                    <measurement group_id="B3" value="78.4" spread="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change (Difference) in Anxiety</title>
        <description>Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety. It is measured on a 100 millimeter line with anchors &quot;No anxiety&quot; to &quot;The most anxiety I can imagine.&quot; Participants make a mark across the line to represent their current state of anxiety. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety.</description>
        <time_frame>Pre-operatively to post-operatively</time_frame>
        <population>thyroid and/or parathyroid surgery patients</population>
        <group_list>
          <group group_id="O1">
            <title>SignatureSuite OR</title>
            <description>Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.&#xD;
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.</description>
          </group>
          <group group_id="O2">
            <title>Standard OR</title>
            <description>Patients who's surgeon has been randomized into the standard operating room.</description>
          </group>
        </group_list>
        <measure>
          <title>Change (Difference) in Anxiety</title>
          <description>Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety. It is measured on a 100 millimeter line with anchors &quot;No anxiety&quot; to &quot;The most anxiety I can imagine.&quot; Participants make a mark across the line to represent their current state of anxiety. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety.</description>
          <population>thyroid and/or parathyroid surgery patients</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.4" lower_limit="-31.7" upper_limit="-17.0"/>
                    <measurement group_id="O2" value="-17.6" lower_limit="-25.1" upper_limit="-10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.20</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.1</ci_lower_limit>
            <ci_upper_limit>3.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures</title>
        <description>Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit</description>
        <time_frame>Pre-operative to post-operative</time_frame>
        <population>Patients undergoing thyroid and/or parathyroid surgery</population>
        <group_list>
          <group group_id="O1">
            <title>SignatureSuite OR</title>
            <description>The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.&#xD;
SignatureSuite OR Integration System by STERIS Corporation: SignatureSuite OR Integration System by STERIS Corporation is a device that controls audio and visual components of the operating room environment in order to provide a more relaxing and calming operating room environment for patients prior to surgery and on emergence from anesthesia after surgery.</description>
          </group>
          <group group_id="O2">
            <title>Standard OR</title>
            <description>Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures</title>
          <description>Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit</description>
          <population>Patients undergoing thyroid and/or parathyroid surgery</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" lower_limit="-9.8" upper_limit="1.4"/>
                    <measurement group_id="O2" value="-6.4" lower_limit="-12.3" upper_limit="-0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.60</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.9</ci_lower_limit>
            <ci_upper_limit>10.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates</title>
        <description>Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit</description>
        <time_frame>Pre-operative to post-operative</time_frame>
        <population>Patients undergoing thyroid and/or parathyroid surgery</population>
        <group_list>
          <group group_id="O1">
            <title>SignatureSuite OR</title>
            <description>Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.&#xD;
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.</description>
          </group>
          <group group_id="O2">
            <title>Standard OR</title>
            <description>Patients who's surgeon has been randomized into the standard operating room.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates</title>
          <description>Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit</description>
          <population>Patients undergoing thyroid and/or parathyroid surgery</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="-1.3" upper_limit="7.5"/>
                    <measurement group_id="O2" value="4.1" lower_limit="-0.2" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.76</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.0</ci_lower_limit>
            <ci_upper_limit>5.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Analgesic Use</title>
        <description>Number of people requiring analgesia in the post-anesthesia care unit</description>
        <time_frame>Postoperatively</time_frame>
        <population>Patients that have undergone thyroid and/or parathyroid surgery</population>
        <group_list>
          <group group_id="O1">
            <title>SignatureSuite OR</title>
            <description>Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.&#xD;
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.</description>
          </group>
          <group group_id="O2">
            <title>Standard OR</title>
            <description>Patients who's surgeon has been randomized into the standard operating room.</description>
          </group>
        </group_list>
        <measure>
          <title>Analgesic Use</title>
          <description>Number of people requiring analgesia in the post-anesthesia care unit</description>
          <population>Patients that have undergone thyroid and/or parathyroid surgery</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.83</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Postoperatively until discharged from the post-anesthesia care unit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SignatureSuite OR</title>
          <description>Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.&#xD;
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.</description>
        </group>
        <group group_id="E2">
          <title>Standard OR</title>
          <description>Patients who's surgeon has been randomized into the standard operating room.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study was conducted at one community hospital in Northeast Ohio. Study population limited to patients having thyroid or parathyroid surgery. Low dose anxiolytic given intravenously in the preoperative holding area prior to being moved to the OR.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Christian N. Burchill, PhD, RN, CEN</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>216-445-9317</phone>
      <email>burchic@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03037905
org study id: CCF15-009
nct id: NCT03037905
lead sponsor: 
collaborator: 
has dmc: No
Anxiety prior to surgery is an expected emotion. Research has not been conducted on methods
      to reduce anxiety in the operating room itself. STERIS Corporation has developed an automated
      surgical suite environmental system, called SignatureSuite™, that controls the level of
      lighting, images on OR monitors, and ambient background audio via preset, computerized
      automation for use before and after anesthesia. This study aims to determine if this new type
      of operating room environment decreases anxiety, as measured by patient responses on anxiety
      visual analog scales, heart rate, systolic blood pressure, and postoperative analgesic use.
      The proposed study will be a two-arm, randomized controlled trial comparing anxiety levels
      for patients that have thyroid or parathyroid surgery in the SignatureSuite room at Cleveland
      Clinic Marymount Hospital versus the standard operating room environment. Randomization will
      occur at the surgeon level. There will be a maximum 100 patients divided equally between the
      experimental and control arms of the study.
Problem: Anxiety prior to surgery is an expected emotion. Research has been conducted on
      methods to reduce anxiety prior to entering the operating room (OR). These studies have
      involved some form of distraction, almost all finding that some form of distraction prior to
      entering the OR decreases both physiologic signs and patient reports of anxiety. Very few of
      these studies have carried the intervention into the OR itself. Steris Corporation has
      developed an automated surgical suite environmental system, called SignatureSuite™, that
      controls the level of lighting, images on OR monitors, and ambient background audio via
      preset, computerized automation for use before and after anesthesia. The research question
      is: What is the effect of the SignatureSuite OR environment on patient anxiety and analgesic
      use? Study methods: The proposed study will be a two arm randomized controlled trial.
      Randomization will occur at the surgeon level, based on SignatureSuite operating room
      environment (experimental group) versus a standard Marymount Hospital operating room
      environment (control group).

      Data collection: The study will take place in the perioperative department of Cleveland
      Clinic's Marymount Hospital. Patient anxiety will be measured before and after surgery using
      an anxiety visual analog scale (VAS). Data about patient characteristics will be retrieved
      retrospectively by chart review. The effect of SignatureSuite on OR time will also be
      determined.

      Sample characteristics: The patient sample will comprise patients undergoing thyroid and/or
      parathyroid surgery at Cleveland Clinic Marymount Hospital.

      Sample size: 40 subjects per group will provide adequate power to detect large effect sizes
      (0.80) and is feasible in a reasonable period of time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change (Difference) in Anxiety
time frame: Pre-operatively to post-operatively
description: Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety. It is measured on a 100 millimeter line with anchors "No anxiety" to "The most anxiety I can imagine." Participants make a mark across the line to represent their current state of anxiety. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety.
measure: Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures
time frame: Pre-operative to post-operative
description: Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit
measure: Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates
time frame: Pre-operative to post-operative
description: Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit
measure: Analgesic Use
time frame: Postoperatively
description: Number of people requiring analgesia in the post-anesthesia care unit
arm group label: SignatureSuite OR
arm group type: Experimental
description: The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.
arm group label: Standard OR
arm group type: No Intervention
description: Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.
intervention type: Device
intervention name: SignatureSuite OR Integration System by STERIS Corporation
description: SignatureSuite OR Integration System by STERIS Corporation is a device that controls audio and visual components of the operating room environment in order to provide a more relaxing and calming operating room environment for patients prior to surgery and on emergence from anesthesia after surgery.
arm group label: SignatureSuite OR
other name: SignatureSuite
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Christian N Burchill, PhD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Christian Burchill
investigator title: Nurse Scientist II
sharing ipd: No
ipd description: No data to be shared
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was conducted at one community hospital in Northeast Ohio. Study population limited to patients having thyroid or parathyroid surgery. Low dose anxiolytic given intravenously in the preoperative holding area prior to being moved to the OR.
point of contact: 