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/NCT06030921</url>
    </required_header>
    <id_info>
      <org_study_id>16059</org_study_id>
      <nct_id>NCT06030921</nct_id>
    </id_info>
    <brief_title>Effects of State Trait Anxiety on Thorax, Diaphragm and Related Fascia.</brief_title>
    <official_title>Effects of State Trait Anxiety on Thorax, Diaphragm and Related Fascia.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Touro College and University System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Touro College and University System</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>
        Previous studies have accepted a strong correlation between anxiety and dysregulation in&#xD;
        respiratory rate. The investigators would like to explore this correlation from an&#xD;
        osteopathic perspective. The investigators seek to assess the muscles, bones, ligaments, and&#xD;
        fascia related to the respiratory system, mainly the thoracic diaphragm. The study does not&#xD;
        focus on clinically diagnosed General Anxiety Disorder but rather State-Trait Anxiety among&#xD;
        medical student participants. State Anxiety is the temporary anxiety one feels in certain&#xD;
        situations, and Trait Anxiety is the stable tendency to become anxious.&#xD;
  &#xD;
        The investigators aim to assess somatic dysfunctions in medical students' respiratory systems&#xD;
        and correlate those findings with their respective scores on the State-Trait Inventory for&#xD;
        Cognitive and Somatic Anxiety (STICSA) survey. The investigators will assess the patient's&#xD;
        somatic dysfunction using an osteopathic structural exam, and the STICSA will quantify the&#xD;
        patient's level of statetrait anxiety. This inquiry will further explore osteopathic&#xD;
        medicine's perspective on addressing the patient as a whole by correlating the close&#xD;
        relationship between one's mental state and the resultant physical dysfunctions within&#xD;
        different areas of the body. Establishing this correlation can pave the way for a new&#xD;
        perspective on treating mental health disorders that is both cost-effective and potentially&#xD;
        more efficacious than the traditional method, which has a high relapse rate. Exploring the&#xD;
        connection between somatic dysfunctions and state-trait anxiety will benefit the patient's&#xD;
        overall well-being and add a new level of care that osteopathic physicians can provide to&#xD;
        others.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A common pattern in nature is that dysfunctions manifest in more than one way and on more&#xD;
        than one canvas. For example, climate change is predicted to manifest as rising sea levels,&#xD;
        warmer sea temperatures, destruction of coral reefs, droughts, and crop failure. This same&#xD;
        pattern is seen physiologically as well. Osteopathic physicians commonly see a pattern of&#xD;
        somatic dysfunctions secondary to a visceral pathology. Some viscerosomatic pathologies have&#xD;
        predictable manifestations, seen as Chapman points, small tender nodules within deep fascia.&#xD;
        This present study follows a similar investigation but attempts to connect the visceral&#xD;
        emotion of anxiety with somatic dysfunctions seen in fascia. A growing body of literature has&#xD;
        connected emotions to the physical body and the mechanism involved in this&#xD;
        interconnectedness. This present study will not focus on elucidating new mechanisms, rather&#xD;
        it will focus on using osteopathic medicine as the tool to assess the physical manifestations&#xD;
        of state-trait anxiety.&#xD;
  &#xD;
        Individuals with mental disorders have increased adverse health behaviors, higher rates of&#xD;
        chronic medical conditions, and increased mortality. Out of all of the mental disorders,&#xD;
        anxiety has the highest prevalence. A substantial percentage of students within health&#xD;
        science programs ie. nursing, medicine, and pharmacy, have reported elevated scores on&#xD;
        self-reported anxiety questionnaires during their first year. A recent study by Hoying et al.&#xD;
        2020 reported that 30% of graduate students in health science programs had elevated scores on&#xD;
        self-reported anxiety measures when entering their first year. This is pertinent to the&#xD;
        present study as most of the participants will be recruited from Touro COM's first-year OMS-I&#xD;
        class. Additionally, most studies have focused on the clinical form of anxiety, such as&#xD;
        generalized anxiety disorder, but few have thoroughly addressed the subclinical forms of&#xD;
        anxiety. The present study focuses on state and trait anxiety as defined by Spileberger.&#xD;
        State anxiety is the proclivity of one to perceive a situation as threatening and transiently&#xD;
        experience apprehension, tension, and dread. Trait anxiety is the stable inclination to&#xD;
        experience state anxiety to varying external stimuli.&#xD;
  &#xD;
        Despite extensive research focused on the treatment of clinical forms of anxiety, remission&#xD;
        rates remain low, most notably less than 50% remission in patients with a generalized anxiety&#xD;
        disorder (GAD). The standard of care involves both pharmacologic and psychological&#xD;
        modalities, but nevertheless, the desired outcome of complete remission is not achieved.&#xD;
        Therefore, there is a push in the scientific community to investigate anxiety through the&#xD;
        lens of alternative and complementary medicines (CAM). While this study does not propose a&#xD;
        novel treatment modality for state-trait anxiety, it does propose a new lens through which&#xD;
        state-trait anxiety can be assessed and further examined. Using osteopathic manipulative&#xD;
        medicine, the examiners uncover physical manifestations of anxiety that might have been&#xD;
        overlooked when using standard-of-care modalities. This study will examine how anxiety&#xD;
        manifests in one's bones, muscles, ligaments, and other objective measures.&#xD;
  &#xD;
        This study will focus exclusively on the thoracic (respiratory) diaphragm and related fascia&#xD;
        to fully examine osteopathic medicine as a tool for assessing state-trait anxiety. The&#xD;
        investigators believe that maximal convergence between the mechanisms that govern fascia,&#xD;
        anxiety, and their physical manifestations is located within the thoracic fascia and its&#xD;
        relationship to the diaphragm. Previous studies have explored the relationship between one's&#xD;
        breathing rate and their measures on anxiety questionnaires. It is widely accepted that&#xD;
        anxiety affects one's breathing rate and quality. To examine the related fascia to the&#xD;
        thoracic diaphragm, the study will include structures enveloped by Sibson's fascia and the&#xD;
        endothoracic fascia. These structures include muscles such as the sternocleidomastoid,&#xD;
        anterior/posterior/middle scalene, external intercostals, pectoralis minor, and the thoracic&#xD;
        diaphragm itself. The related bones include ribs 1 -12, the sternum, the xiphoid process, the&#xD;
        L1-L3 vertebral bodies, and the L1-L3 Intervertebral disk. The ligaments include the right&#xD;
        and left crus. Additionally, it is pertinent to measure subjects' respiratory rate, Co2&#xD;
        retention, diaphragmatic excursion, and any somatic dysfunctions found in their thoracic&#xD;
        inlet or related to Zinc's common compensatory patterns. Assessment with osteopathic&#xD;
        manipulative medicine is a viable, cost-effective, and sustainable solution for assessing&#xD;
        anxiety.&#xD;
  &#xD;
        Using the osteopathic structural exam, this study aims to correlate subjective and objective&#xD;
        findings of measures stated above with participants' responses on the State-Trait Inventory&#xD;
        for Cognitive and Somatic Anxiety (STICSA) questionnaire. The STICSA inventory was chosen due&#xD;
        to its superior ability to divide anxiety's cognitive and somatic aspects and distinguish&#xD;
        state and trait anxiety. STICSA is also superior to the widely used State-Trait Anxiety&#xD;
        Inventory in distinguishing between state-trait anxiety and depression.&#xD;
  &#xD;
        This study is fundamental in furthering science's understanding of the intricate nature&#xD;
        governing the mind-body connection. It is undeniable that one's psychological state&#xD;
        influences one's physical well-being. Currently, there is a movement toward uncovering and&#xD;
        exploring the biochemical, hormonal, and physiological interplay between the mind and the&#xD;
        body. This study puts into action these discoveries and attempts to build a foundational&#xD;
        framework on which future treatment modalities can be based. By examining state-trait anxiety&#xD;
        through an osteopathic structural exam, focused on the thoracic diaphragm and its related&#xD;
        fascial connection, this study attempts to quantify and qualify how state-trait anxiety&#xD;
        manifests in one's body. If there is a significant result from our findings, it will call for&#xD;
        many studies to replicate the results and, subsequently, future studies that use this&#xD;
        foundation to find new ways to treat state-trait anxiety and potentially extrapolate these&#xD;
        findings to different mental health diseases. This study has the potential to pivot the&#xD;
        modern approach to assessing and treating mental health diseases. In addition, assessment&#xD;
        with osteopathic manipulative medicine is a viable, cost-effective, and sustainable solution&#xD;
        for assessing anxiety.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Numerical scores collected from the STICSA survey</measure>
      <time_frame>Through study completion, an average of 1 year.</time_frame>
      <description>Numerical scores collected from the STICSA survey</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quantity and Quality of Somatic Dysfunctions as examined by Osteopathic Structural Exam</measure>
      <time_frame>Through study completion, an average of 1 year.</time_frame>
      <description>Quantity and Quality of Somatic Dysfunctions as examined by Osteopathic Structural Exam</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Anxiety State</condition>
    <condition>Fascia; Anomaly</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Osteopathic Structural Exam, State - Trait Anxiety Questionnaire</intervention_name>
      <description>During a single patient encounter they will fill out the State-Trait Anxiety Questionnaire , and undergo a Osteopathic Structural Exam</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Touro College of Osteopathic Medicine Students, male and female, aged from 18-45.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Touro College of Osteopathic Medicine Students of Harlem, Middletown, and Montana&#xD;
               campus.&#xD;
  &#xD;
            -  Students from OMS-I to OMS-IV.&#xD;
  &#xD;
            -  Participants aged 18 - 45.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous history of generalized anxiety, depression, mania or hypomania, as defined by&#xD;
               the DSM-IV, or a history of a bipolar mood disorder, personality disorder, or&#xD;
               psychotic disorder.&#xD;
  &#xD;
            -  Presence of a cognitive disorder or dementia within 6 months before the baseline&#xD;
               visit.&#xD;
  &#xD;
            -  Investigator believed there was a significant risk of suicide.&#xD;
  &#xD;
            -  Currently pregnant, lactating, o intending to become pregnant before, during, or&#xD;
               within 30 days after participating in the study.&#xD;
  &#xD;
            -  Changes in medication use or psychotherapy during study period&#xD;
  &#xD;
            -  Presence of any other significant organic disease or serious illness (eg, cardiac,&#xD;
               endocrine, gastrointestinal, infectious, liver or renal insufficiency, metabolic&#xD;
               disturbance, neoplastic, neurologic, pulmonary, or vascular).&#xD;
  &#xD;
            -  Presence of any history of respiratory disorders including but not limited to asthma,&#xD;
               COPD, emphysema&#xD;
  &#xD;
            -  History of abdominal or thoracic trauma or surgery within the past 10 years.&#xD;
  &#xD;
            -  Medication: Sympathomimetics, respiratory depressants&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Anton D Livshin, BS</last_name>
      <phone>5166605456</phone>
      <email>alivshin@student.touro.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mikhail Volokitin, MD, DO</last_name>
      <phone>(646) 258-3408</phone>
      <email>Mikhail.Volokitin@touro.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Touro College of Osteopathic Medicine</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10027</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mikhail Volokitin, MD, DO</last_name>
        <phone>646-258-3408</phone>
        <email>Mikhail.Volokitin@touro.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Church JA. Climate change. How fast are sea levels rising? Science. 2001 Oct 26;294(5543):802-3. doi: 10.1126/science.1065714.</citation>
      <PMID>11679657</PMID>
    </reference>
    <reference>
      <citation>Ateweberhan M, McClanahan TR. Relationship between historical sea-surface temperature variability and climate change-induced coral mortality in the western Indian Ocean. Mar Pollut Bull. 2010 Jul;60(7):964-70. doi: 10.1016/j.marpolbul.2010.03.033. Epub 2010 May 5.</citation>
      <PMID>20447661</PMID>
    </reference>
    <reference>
      <citation>Bath M, Owens J. Physiology, Viscerosomatic Reflexes. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559218/</citation>
      <PMID>32644644</PMID>
    </reference>
    <reference>
      <citation>Lookadoo RE, Bell JE. Public Health Policy Actions to Address Health Issues Associated with Drought in a Changing Climate. J Law Med Ethics. 2020 Dec;48(4):653-663. doi: 10.1177/1073110520979372.</citation>
      <PMID>33404338</PMID>
    </reference>
    <reference>
      <citation>Walker ER, McGee RE, Druss BG. Mortality in mental disorders and global disease burden implications: a systematic review and meta-analysis. JAMA Psychiatry. 2015 Apr;72(4):334-41. doi: 10.1001/jamapsychiatry.2014.2502. Erratum In: JAMA Psychiatry. 2015 Jul;72(7):736. JAMA Psychiatry. 2015 Dec;72(12):1259.</citation>
      <PMID>25671328</PMID>
    </reference>
    <reference>
      <citation>Hoying J, Melnyk BM, Hutson E, Tan A. Prevalence and Correlates of Depression, Anxiety, Stress, Healthy Beliefs, and Lifestyle Behaviors in First-Year Graduate Health Sciences Students. Worldviews Evid Based Nurs. 2020 Feb;17(1):49-59. doi: 10.1111/wvn.12415. Epub 2020 Jan 8.</citation>
      <PMID>31912989</PMID>
    </reference>
    <reference>
      <citation>Mazurek Melnyk B, Slevin C, Militello L, Hoying J, Teall A, McGovern C. Physical health, lifestyle beliefs and behaviors, and mental health of entering graduate health professional students: Evidence to support screening and early intervention. J Am Assoc Nurse Pract. 2016 Apr;28(4):204-11. doi: 10.1002/2327-6924.12350. Epub 2016 Mar 16.</citation>
      <PMID>26990269</PMID>
    </reference>
    <reference>
      <citation>Endler NS, Kocovski NL. State and trait anxiety revisited. J Anxiety Disord. 2001 May-Jun;15(3):231-45. doi: 10.1016/s0887-6185(01)00060-3.</citation>
      <PMID>11442141</PMID>
    </reference>
    <reference>
      <citation>Spielberger, C. D. (1985a). &quot;Anxiety, cognition and aﬀect: a state-trait perspective,&quot; in Anxiety and the Anxiety Disorders, eds A. H. Tuma, and J. D. Maser (Hillsdale, NJ: Lawrence Erlbaum Associates, Inc), 171-182</citation>
    </reference>
    <reference>
      <citation>Dixon L, Fotinos K, Sherifi E, Lokuge S, Fine A, Furtado M, Anand L, Liberatore K, Katzman MA. Effect of Osteopathic Manipulative Therapy on Generalized Anxiety Disorder. J Am Osteopath Assoc. 2020 Mar 1;120(3):133-143. doi: 10.7556/jaoa.2020.026.</citation>
      <PMID>32091557</PMID>
    </reference>
    <reference>
      <citation>Katzman MA, Bleau P, Blier P, Chokka P, Kjernisted K, Van Ameringen M; Canadian Anxiety Guidelines Initiative Group on behalf of the Anxiety Disorders Association of Canada/Association Canadienne des troubles anxieux and McGill University; Antony MM, Bouchard S, Brunet A, Flament M, Grigoriadis S, Mendlowitz S, O'Connor K, Rabheru K, Richter PM, Robichaud M, Walker JR. Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders. BMC Psychiatry. 2014;14 Suppl 1(Suppl 1):S1. doi: 10.1186/1471-244X-14-S1-S1. Epub 2014 Jul 2.</citation>
      <PMID>25081580</PMID>
    </reference>
    <reference>
      <citation>Ravindran AV, da Silva TL. Complementary and alternative therapies as add-on to pharmacotherapy for mood and anxiety disorders: a systematic review. J Affect Disord. 2013 Sep 25;150(3):707-19. doi: 10.1016/j.jad.2013.05.042. Epub 2013 Jun 12.</citation>
      <PMID>23769610</PMID>
    </reference>
    <reference>
      <citation>Ritz T, Meuret AE, Bhaskara L, Petersen S. Respiratory muscle tension as symptom generator in individuals with high anxiety sensitivity. Psychosom Med. 2013 Feb;75(2):187-95. doi: 10.1097/PSY.0b013e31827d1072. Epub 2013 Jan 16.</citation>
      <PMID>23324873</PMID>
    </reference>
    <reference>
      <citation>Wan HY, Stickford JL, Kitano K, Manz WJ, Koceja DM, Chapman RF, Stager JM. Acute hypercapnia does not alter voluntary drive to the diaphragm in healthy humans. Respir Physiol Neurobiol. 2018 Dec;258:60-68. doi: 10.1016/j.resp.2018.05.012. Epub 2018 May 30.</citation>
      <PMID>29859322</PMID>
    </reference>
    <reference>
      <citation>Bailey JE, Argyropoulos SV, Kendrick AH, Nash J, Jightman S, Nutt DJ. Inhalation of 35% CO2 results in subjective fear and activates the HPA axis in healthy volunteers. J Psychopharmacol. 2001;15:A22.</citation>
    </reference>
    <reference>
      <citation>Freire RC, Nardi AE. Panic disorder and the respiratory system: clinical subtype and challenge tests. Braz J Psychiatry. 2012 Jun;34 Suppl 1:S32-41. doi: 10.1590/s1516-44462012000500004. English, Portuguese.</citation>
      <PMID>22729448</PMID>
    </reference>
    <reference>
      <citation>Gilbert, C. (1998). Hyperventilation and the body. Journal of Bodywork and Movement Therapies, 2(3), 184-191</citation>
    </reference>
    <reference>
      <citation>Tindall IK, Curtis GJ, Locke V. Dimensionality and Measurement Invariance of the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) and Validity Comparison With Measures of Negative Emotionality. Front Psychol. 2021 Jun 7;12:644889. doi: 10.3389/fpsyg.2021.644889. eCollection 2021.</citation>
      <PMID>34163400</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Touro College and University System</investigator_affiliation>
      <investigator_full_name>Mikhail Volokitin, MD, DO.</investigator_full_name>
      <investigator_title>Principal Investigator, Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Anxiety State, Fascial Strain, Osteopathic Medicine</keyword>
    <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>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/NCT06030921
  org study id: 16059
  nct id: NCT06030921
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Previous studies have accepted a strong correlation between anxiety and dysregulation in
        respiratory rate. The investigators would like to explore this correlation from an
        osteopathic perspective. The investigators seek to assess the muscles, bones, ligaments, and
        fascia related to the respiratory system, mainly the thoracic diaphragm. The study does not
        focus on clinically diagnosed General Anxiety Disorder but rather State-Trait Anxiety among
        medical student participants. State Anxiety is the temporary anxiety one feels in certain
        situations, and Trait Anxiety is the stable tendency to become anxious.
  
        The investigators aim to assess somatic dysfunctions in medical students' respiratory systems
        and correlate those findings with their respective scores on the State-Trait Inventory for
        Cognitive and Somatic Anxiety (STICSA) survey. The investigators will assess the patient's
        somatic dysfunction using an osteopathic structural exam, and the STICSA will quantify the
        patient's level of statetrait anxiety. This inquiry will further explore osteopathic
        medicine's perspective on addressing the patient as a whole by correlating the close
        relationship between one's mental state and the resultant physical dysfunctions within
        different areas of the body. Establishing this correlation can pave the way for a new
        perspective on treating mental health disorders that is both cost-effective and potentially
        more efficacious than the traditional method, which has a high relapse rate. Exploring the
        connection between somatic dysfunctions and state-trait anxiety will benefit the patient's
        overall well-being and add a new level of care that osteopathic physicians can provide to
        others.
  A common pattern in nature is that dysfunctions manifest in more than one way and on more
        than one canvas. For example, climate change is predicted to manifest as rising sea levels,
        warmer sea temperatures, destruction of coral reefs, droughts, and crop failure. This same
        pattern is seen physiologically as well. Osteopathic physicians commonly see a pattern of
        somatic dysfunctions secondary to a visceral pathology. Some viscerosomatic pathologies have
        predictable manifestations, seen as Chapman points, small tender nodules within deep fascia.
        This present study follows a similar investigation but attempts to connect the visceral
        emotion of anxiety with somatic dysfunctions seen in fascia. A growing body of literature has
        connected emotions to the physical body and the mechanism involved in this
        interconnectedness. This present study will not focus on elucidating new mechanisms, rather
        it will focus on using osteopathic medicine as the tool to assess the physical manifestations
        of state-trait anxiety.
  
        Individuals with mental disorders have increased adverse health behaviors, higher rates of
        chronic medical conditions, and increased mortality. Out of all of the mental disorders,
        anxiety has the highest prevalence. A substantial percentage of students within health
        science programs ie. nursing, medicine, and pharmacy, have reported elevated scores on
        self-reported anxiety questionnaires during their first year. A recent study by Hoying et al.
        2020 reported that 30% of graduate students in health science programs had elevated scores on
        self-reported anxiety measures when entering their first year. This is pertinent to the
        present study as most of the participants will be recruited from Touro COM's first-year OMS-I
        class. Additionally, most studies have focused on the clinical form of anxiety, such as
        generalized anxiety disorder, but few have thoroughly addressed the subclinical forms of
        anxiety. The present study focuses on state and trait anxiety as defined by Spileberger.
        State anxiety is the proclivity of one to perceive a situation as threatening and transiently
        experience apprehension, tension, and dread. Trait anxiety is the stable inclination to
        experience state anxiety to varying external stimuli.
  
        Despite extensive research focused on the treatment of clinical forms of anxiety, remission
        rates remain low, most notably less than 50% remission in patients with a generalized anxiety
        disorder (GAD). The standard of care involves both pharmacologic and psychological
        modalities, but nevertheless, the desired outcome of complete remission is not achieved.
        Therefore, there is a push in the scientific community to investigate anxiety through the
        lens of alternative and complementary medicines (CAM). While this study does not propose a
        novel treatment modality for state-trait anxiety, it does propose a new lens through which
        state-trait anxiety can be assessed and further examined. Using osteopathic manipulative
        medicine, the examiners uncover physical manifestations of anxiety that might have been
        overlooked when using standard-of-care modalities. This study will examine how anxiety
        manifests in one's bones, muscles, ligaments, and other objective measures.
  
        This study will focus exclusively on the thoracic (respiratory) diaphragm and related fascia
        to fully examine osteopathic medicine as a tool for assessing state-trait anxiety. The
        investigators believe that maximal convergence between the mechanisms that govern fascia,
        anxiety, and their physical manifestations is located within the thoracic fascia and its
        relationship to the diaphragm. Previous studies have explored the relationship between one's
        breathing rate and their measures on anxiety questionnaires. It is widely accepted that
        anxiety affects one's breathing rate and quality. To examine the related fascia to the
        thoracic diaphragm, the study will include structures enveloped by Sibson's fascia and the
        endothoracic fascia. These structures include muscles such as the sternocleidomastoid,
        anterior/posterior/middle scalene, external intercostals, pectoralis minor, and the thoracic
        diaphragm itself. The related bones include ribs 1 -12, the sternum, the xiphoid process, the
        L1-L3 vertebral bodies, and the L1-L3 Intervertebral disk. The ligaments include the right
        and left crus. Additionally, it is pertinent to measure subjects' respiratory rate, Co2
        retention, diaphragmatic excursion, and any somatic dysfunctions found in their thoracic
        inlet or related to Zinc's common compensatory patterns. Assessment with osteopathic
        manipulative medicine is a viable, cost-effective, and sustainable solution for assessing
        anxiety.
  
        Using the osteopathic structural exam, this study aims to correlate subjective and objective
        findings of measures stated above with participants' responses on the State-Trait Inventory
        for Cognitive and Somatic Anxiety (STICSA) questionnaire. The STICSA inventory was chosen due
        to its superior ability to divide anxiety's cognitive and somatic aspects and distinguish
        state and trait anxiety. STICSA is also superior to the widely used State-Trait Anxiety
        Inventory in distinguishing between state-trait anxiety and depression.
  
        This study is fundamental in furthering science's understanding of the intricate nature
        governing the mind-body connection. It is undeniable that one's psychological state
        influences one's physical well-being. Currently, there is a movement toward uncovering and
        exploring the biochemical, hormonal, and physiological interplay between the mind and the
        body. This study puts into action these discoveries and attempts to build a foundational
        framework on which future treatment modalities can be based. By examining state-trait anxiety
        through an osteopathic structural exam, focused on the thoracic diaphragm and its related
        fascial connection, this study attempts to quantify and qualify how state-trait anxiety
        manifests in one's body. If there is a significant result from our findings, it will call for
        many studies to replicate the results and, subsequently, future studies that use this
        foundation to find new ways to treat state-trait anxiety and potentially extrapolate these
        findings to different mental health diseases. This study has the potential to pivot the
        modern approach to assessing and treating mental health diseases. In addition, assessment
        with osteopathic manipulative medicine is a viable, cost-effective, and sustainable solution
        for assessing anxiety.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Numerical scores collected from the STICSA survey
  time frame: Through study completion, an average of 1 year.
  description: Numerical scores collected from the STICSA survey
  measure: Quantity and Quality of Somatic Dysfunctions as examined by Osteopathic Structural Exam
  time frame: Through study completion, an average of 1 year.
  description: Quantity and Quality of Somatic Dysfunctions as examined by Osteopathic Structural Exam
  intervention type: Other
  intervention name: Osteopathic Structural Exam, State - Trait Anxiety Questionnaire
  description: During a single patient encounter they will fill out the State-Trait Anxiety Questionnaire , and undergo a Osteopathic Structural Exam
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  last name: Anton D Livshin, BS
  phone: 5166605456
  email: alivshin@student.touro.edu
  last name: Mikhail Volokitin, MD, DO
  phone: (646) 258-3408
  email: Mikhail.Volokitin@touro.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
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  PMID: 34163400
  responsible party type: Principal Investigator
  investigator affiliation: The Touro College and University System
  investigator full name: Mikhail Volokitin, MD, DO.
  investigator title: Principal Investigator, Associate Professor
  mesh term: Anxiety Disorders
  sharing ipd: No