Anxiety StateNCT06030921
Effects of State Trait Anxiety on Thorax, Diaphragm and Related Fascia.
An observational study of Anxiety State and Fascia; Anomaly, run by The Touro College and University System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anxiety State, Fascia; Anomaly
- What is being tested?
- Osteopathic Structural Exam, State - Trait Anxiety Questionnaire
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Touro College of Osteopathic Medicine Students, male and female, aged from 18-45.
Who may be able to join
- Touro College of Osteopathic Medicine Students of Harlem, Middletown, and Montana campus.
- Students from OMS-I to OMS-IV.
- Participants aged 18 - 45.
Who cannot join
- Previous history of generalized anxiety, depression, mania or hypomania, as defined by the DSM-IV, or a history of a bipolar mood disorder, personality disorder, or psychotic disorder.
- Presence of a cognitive disorder or dementia within 6 months before the baseline visit.
- Investigator believed there was a significant risk of suicide.
- Currently pregnant, lactating, o intending to become pregnant before, during, or within 30 days after participating in the study.
- Changes in medication use or psychotherapy during study period
- Presence of any other significant organic disease or serious illness (eg, cardiac, endocrine, gastrointestinal, infectious, liver or renal insufficiency, metabolic disturbance, neoplastic, neurologic, pulmonary, or vascular).
Show all 9Show fewer
- Presence of any history of respiratory disorders including but not limited to asthma, COPD, emphysema
- History of abdominal or thoracic trauma or surgery within the past 10 years.
- Medication: Sympathomimetics, respiratory depressants
Trial locations and contacts
1 site in 1 country.
United States1 site
Touro College of Osteopathic Medicine
New York, New York, 10027
About this study
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.
Read the detailed description
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.
- Conditions
- Anxiety State, Fascia; Anomaly
- Being tested
- Osteopathic Structural Exam, State - Trait Anxiety Questionnaire
- Keywords
- Anxiety State, Fascial Strain, Osteopathic Medicine
- Medical subject headings
- Anxiety Disorders, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Structural Exam, State - Trait Anxiety QuestionnaireOther
During a single patient encounter they will fill out the State-Trait Anxiety Questionnaire , and undergo a Osteopathic Structural Exam
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical scores collected from the STICSA survey
Numerical scores collected from the STICSA survey
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Quantity and Quality of Somatic Dysfunctions as examined by Osteopathic Structural Exam
Quantity and Quality of Somatic Dysfunctions as examined by Osteopathic Structural Exam
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Feb 2023
- Primary completion1 Oct 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Touro College and University System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhail Volokitin, MD, DO., The Touro College and University System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030921
- Sponsor's protocol ID
- 16059
- Status last verified
- Mar 2025
- First submitted
- 23 Aug 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Church JA. Climate change. How fast are sea levels rising? Science. 2001 Oct 26;294(5543):802-3. doi: 10.1126/science.1065714.
PubMed 11679657Ateweberhan 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.
PubMed 20447661Bath M, Owens J. Physiology, Viscerosomatic Reflexes. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559218/
PubMed 32644644Lookadoo 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.
PubMed 33404338Walker 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.
PubMed 25671328Hoying 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.
PubMed 31912989Mazurek 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.
PubMed 26990269Endler 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.
PubMed 11442141Spielberger, C. D. (1985a). "Anxiety, cognition and affect: a state-trait perspective," in Anxiety and the Anxiety Disorders, eds A. H. Tuma, and J. D. Maser (Hillsdale, NJ: Lawrence Erlbaum Associates, Inc), 171-182
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.
PubMed 32091557Katzman 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.
PubMed 25081580Ravindran 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.
PubMed 23769610Ritz 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.
PubMed 23324873Wan 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.
PubMed 29859322Bailey 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of State Trait Anxiety on Thorax, Diaphragm and Related Fascia.
- ClinicalTrials.gov ID
- NCT06030921
- Acronym / sponsor ID
- 16059
- Conditions
- Anxiety State, Fascia; Anomaly
- Keywords
- Anxiety State, Fascial Strain, Osteopathic Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Touro College and University SystemUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Touro College of Osteopathic Medicine Students, male and female, aged from 18-45.
Key inclusion criteria (3 listed)
- Touro College of Osteopathic Medicine Students of Harlem, Middletown, and Montana campus.
- Students from OMS-I to OMS-IV.
- Participants aged 18 - 45.
Key exclusion criteria (9 listed)
- Previous history of generalized anxiety, depression, mania or hypomania, as defined by the DSM-IV, or a history of a bipolar mood disorder, personality disorder, or psychotic disorder.
- Presence of a cognitive disorder or dementia within 6 months before the baseline visit.
- Investigator believed there was a significant risk of suicide.
- Currently pregnant, lactating, o intending to become pregnant before, during, or within 30 days after participating in the study.
- Changes in medication use or psychotherapy during study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Structural Exam, State - Trait Anxiety QuestionnaireDuring a single patient encounter they will fill out the State-Trait Anxiety Questionnaire , and undergo a Osteopathic Structural Exam | Other | – |
Primary outcome
Numerical scores collected from the STICSA survey
Time frame: Through study completion, an average of 1 year.
Numerical scores collected from the STICSA survey
1 secondary outcome
Quantity and Quality of Somatic Dysfunctions as examined by Osteopathic Structural Exam
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 11679657Church JA. Climate change. How fast are sea levels rising? Science. 2001 Oct 26;294(5543):802-3. doi: 10.1126/science.1065714.
- Background: PubMed 20447661Ateweberhan 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.
- Background: PubMed 32644644Bath M, Owens J. Physiology, Viscerosomatic Reflexes. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559218/
- Background: PubMed 33404338Lookadoo 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.
- Background: PubMed 25671328Walker 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.
- Background: PubMed 31912989Hoying 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.
- Background: PubMed 26990269Mazurek 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.
- Background: PubMed 11442141Endler 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.
- BackgroundSpielberger, C. D. (1985a). "Anxiety, cognition and affect: a state-trait perspective," in Anxiety and the Anxiety Disorders, eds A. H. Tuma, and J. D. Maser (Hillsdale, NJ: Lawrence Erlbaum Associates, Inc), 171-182
- Background: PubMed 32091557Dixon 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.
- Background: PubMed 25081580Katzman 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.
- Background: PubMed 23769610Ravindran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety State and Fascia; Anomaly, run by The Touro College and University System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical scores collected from the STICSA survey (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06030921, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.