CompletedNot Applicable

Effects of State Trait Anxiety on Thorax, Diaphragm and Related Fascia.

United States200 participantsStarted 2023-02-01

Plain-language 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. 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Touro College of Osteopathic Medicine Students of Harlem, Middletown, and Montana campus. * Students from OMS-I to OMS-IV. * Participants aged 18 - 45. Exclusion Criteria: * 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). * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numerical scores collected from the STICSA survey

Timeframe: Through study completion, an average of 1 year.

Trial details

NCT IDNCT06030921

SponsorThe Touro College and University System

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-01

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