NCT06030921

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1.7 years

First QC Date

August 23, 2023

Last Update Submit

March 31, 2025

Conditions

Keywords

Anxiety State, Fascial Strain, Osteopathic Medicine

Outcome Measures

Primary Outcomes (1)

  • Numerical scores collected from the STICSA survey

    Numerical scores collected from the STICSA survey

    Through study completion, an average of 1 year.

Secondary Outcomes (1)

  • Quantity and Quality of Somatic Dysfunctions as examined by Osteopathic Structural Exam

    Through study completion, an average of 1 year.

Interventions

During a single patient encounter they will fill out the State-Trait Anxiety Questionnaire , and undergo a Osteopathic Structural Exam

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Touro College of Osteopathic Medicine Students, male and female, aged from 18-45.

You may qualify if:

  • Touro College of Osteopathic Medicine Students of Harlem, Middletown, and Montana campus.
  • Students from OMS-I to OMS-IV.
  • Participants aged 18 - 45.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Touro College of Osteopathic Medicine

New York, New York, 10027, United States

Location

Related Publications (18)

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    PMID: 25671328BACKGROUND
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    PMID: 31912989BACKGROUND
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    PMID: 26990269BACKGROUND
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    PMID: 11442141BACKGROUND
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    BACKGROUND
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    PMID: 32091557BACKGROUND
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    PMID: 23769610BACKGROUND
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    PMID: 23324873BACKGROUND
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    PMID: 29859322BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    PMID: 34163400BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersCongenital Abnormalities

Condition Hierarchy (Ancestors)

Mental DisordersCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 11, 2023

Study Start

February 1, 2023

Primary Completion

October 1, 2024

Study Completion

February 1, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations