Stress, JobNCT06125574
Investigating the Effects of Osteopathic Manipulative Treatment on Stress Management in Medical Students
A study testing Osteopathic Manipulative Medicine in people with Stress, Job and Student Burnout, run by The Touro College and University System at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate stress biomarkers, subjective stress levels, and cognitive function in medical students. The main question[s] it aims to answer are: Does regular osteopathic manipulative treatment affect stress in medical students? Does regular osteopathic manipulative treatment affect… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Job, Student Burnout, Stress, Physiological
- What is being tested?
- Osteopathic Manipulative Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 30 Sep 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First-year medical students
- Not currently receiving osteopathic manipulative treatment (OMT)
Who cannot join
- Pregnant
- History of spinal surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Touro College of Osteopathic Medicine - Harlem
New York, New York, 10027
About this study
Official title: The Effects of Regular OMT on Stress Levels and Cognitive Function in OMS-I Students at Touro COM-NY Harlem
The goal of this clinical trial is to evaluate stress biomarkers, subjective stress levels, and cognitive function in medical students. The main question[s] it aims to answer are:
Does regular osteopathic manipulative treatment affect stress in medical students? Does regular osteopathic manipulative treatment affect cognitive function in medical students?
Read more
Participants will be split into two groups, control and treatment, and undergo a designated protocol for six weeks. The treatment protocol will include weekly sessions of three OMT techniques: paraspinal inhibition, rib raising, and condylar decompression. Concurrently, participants' salivary cortisol levels will be collected weekly and analyzed using an Invitrogen ELISA Immunoassay Kit. Additionally, cognitive function will be assessed weekly via Lumosity, while stress levels are gauged using the College Student Stress Scale (CSSS) survey.
Researchers will compare one cohort of medical students who receive weekly OMT and another cohort of medical students who have weekly check-ins without OMT to see if OMT can affect changes in stress biomarkers, subjective stress scales, and cognitive function.
- Being tested
- Osteopathic Manipulative Medicine
- Keywords
- Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment, OMM, OMT, Cortisol, Medical Student Stress, Cognitive Function
- Medical subject headings
- Occupational Stress, Burnout, Psychological, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative MedicineOther
Individuals in the experimental cohort will undergo a systematic osteopathic manipulative treatment protocol encompassing paraspinal inhibition, rib raising, and condylar decompression techniques.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: Osteopathic Manipulative Medicine |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Cortisol Level
Salivary Cortisol as measured in an ELISA Immunoassay
Measured: Weekly, over the course of 8 week study
College Student Subjective Stress Survey (CSSS) Numerical Score
Numerical Score collected from the College Student Subjective Stress Survey, a 10-item survey investigating occurrence of stressors over the course of a week, with each item being rated from 1 (Never) to 5 (Very Often). A lower score reflects lower perceived stress while a higher score reflects higher perceived stress.
Measured: Weekly, over the course of 8 week study
LPI
Learning Performance Index Metric from Lumosity
Measured: Weekly, over the course of 8 week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start15 Jun 2023
- Primary completion15 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stress, JobStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 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
- NCT06125574
- Sponsor's protocol ID
- 18777
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bath 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 32644644Degenhardt BF, Darmani NA, Johnson JC, Towns LC, Rhodes DC, Trinh C, McClanahan B, DiMarzo V. Role of osteopathic manipulative treatment in altering pain biomarkers: a pilot study. J Am Osteopath Assoc. 2007 Sep;107(9):387-400.
PubMed 17908831Feldt RC. Development of a brief measure of college stress: the college student stress scale. Psychol Rep. 2008 Jun;102(3):855-60. doi: 10.2466/pr0.102.3.855-860.
PubMed 18763455Licciardone JC, Kearns CM, Hodge LM, Bergamini MV. Associations of cytokine concentrations with key osteopathic lesions and clinical outcomes in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Sep;112(9):596-605. doi: 10.7556/jaoa.2012.112.9.596.
PubMed 22984233Licciardone JC, Schultz MJ, Amen B. Osteopathic Manipulation in the Management of Chronic Pain: Current Perspectives. J Pain Res. 2020 Jul 20;13:1839-1847. doi: 10.2147/JPR.S183170. eCollection 2020.
PubMed 32765058Lee BK, Glass TA, McAtee MJ, Wand GS, Bandeen-Roche K, Bolla KI, Schwartz BS. Associations of salivary cortisol with cognitive function in the Baltimore memory study. Arch Gen Psychiatry. 2007 Jul;64(7):810-8. doi: 10.1001/archpsyc.64.7.810.
PubMed 17606815Saeed SMU, Anwar SM, Khalid H, Majid M, Bagci AU. EEG based Classification of Long-term Stress Using Psychological Labeling. Sensors (Basel). 2020 Mar 29;20(7):1886. doi: 10.3390/s20071886.
PubMed 32235295Schoorlemmer RM, Peeters GM, van Schoor NM, Lips P. Relationships between cortisol level, mortality and chronic diseases in older persons. Clin Endocrinol (Oxf). 2009 Dec;71(6):779-86. doi: 10.1111/j.1365-2265.2009.03552.x. Epub 2009 Feb 18.
PubMed 19226268Shute, V. J., Ventura, M., & Ke, F. (2015). The power of play: The effects of portal 2 and lumosity on cognitive and noncognitive skills. Computers & Education, 80, 58-67.
Valencia R, Anche G, Do Rego Barros G, Arostegui V, Sutaria H, McAllister E, Banihashem M, Volokitin M. Stressbusters: a pilot study investigating the effects of OMT on stress management in medical students. J Osteopath Med. 2024 Dec 19;125(5):261-267. doi: 10.1515/jom-2024-0020. eCollection 2025 May 1.
PubMed 39692236
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Regular OMT on Stress Levels and Cognitive Function in OMS-I Students at Touro COM-NY Harlem
- ClinicalTrials.gov ID
- NCT06125574
- Acronym / sponsor ID
- 18777
- Keywords
- Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment, OMM, OMT, Cortisol, Medical Student Stress, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Touro College and University SystemUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 9 Nov 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.
The goal of this clinical trial is to evaluate stress biomarkers, subjective stress levels, and cognitive function in medical students. The main question[s] it aims to answer are:
Does regular osteopathic manipulative treatment affect stress in medical students? Does regular osteopathic manipulative treatment affect cognitive function in medical students?
Participants will be split into two groups, control and treatment, and undergo a designated protocol for six weeks. The treatment protocol will include weekly sessions of three OMT techniques: paraspinal inhibition, rib raising, and condylar decompression. Concurrently, participants' salivary cortisol levels will be collected weekly and analyzed using an Invitrogen ELISA Immunoassay Kit. Additionally, cognitive function will be assessed weekly via Lumosity, while stress levels are gauged using the College Student Stress Scale (CSSS) survey.
Researchers will compare one cohort of medical students who receive weekly OMT and another cohort of medical students who have weekly check-ins without OMT to see if OMT can affect changes in stress biomarkers, subjective stress scales, and cognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Osteopathic Manipulative Medicine |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First-year medical students
- Not currently receiving osteopathic manipulative treatment (OMT)
Key exclusion criteria (2 listed)
- Pregnant
- History of spinal surgery
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 Manipulative MedicineIndividuals in the experimental cohort will undergo a systematic osteopathic manipulative treatment protocol encompassing paraspinal inhibition, rib raising, and condylar decompression techniques. | Other | Treatment |
Primary outcome
Weekly Cortisol Level
Time frame: Weekly, over the course of 8 week study
Salivary Cortisol as measured in an ELISA Immunoassay
College Student Subjective Stress Survey (CSSS) Numerical Score
Time frame: Weekly, over the course of 8 week study
Numerical Score collected from the College Student Subjective Stress Survey, a 10-item survey investigating occurrence of stressors over the course of a week, with each item being rated from 1 (Never) to 5 (Very Often). A lower score reflects lower perceived stress while a higher score reflects higher perceived stress.
LPI
Time frame: Weekly, over the course of 8 week study
Learning Performance Index Metric from Lumosity
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 14 Nov 2023.
- 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 17908831Degenhardt BF, Darmani NA, Johnson JC, Towns LC, Rhodes DC, Trinh C, McClanahan B, DiMarzo V. Role of osteopathic manipulative treatment in altering pain biomarkers: a pilot study. J Am Osteopath Assoc. 2007 Sep;107(9):387-400.
- Background: PubMed 18763455Feldt RC. Development of a brief measure of college stress: the college student stress scale. Psychol Rep. 2008 Jun;102(3):855-60. doi: 10.2466/pr0.102.3.855-860.
- Background: PubMed 22984233Licciardone JC, Kearns CM, Hodge LM, Bergamini MV. Associations of cytokine concentrations with key osteopathic lesions and clinical outcomes in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Sep;112(9):596-605. doi: 10.7556/jaoa.2012.112.9.596.
- Background: PubMed 32765058Licciardone JC, Schultz MJ, Amen B. Osteopathic Manipulation in the Management of Chronic Pain: Current Perspectives. J Pain Res. 2020 Jul 20;13:1839-1847. doi: 10.2147/JPR.S183170. eCollection 2020.
- Background: PubMed 17606815Lee BK, Glass TA, McAtee MJ, Wand GS, Bandeen-Roche K, Bolla KI, Schwartz BS. Associations of salivary cortisol with cognitive function in the Baltimore memory study. Arch Gen Psychiatry. 2007 Jul;64(7):810-8. doi: 10.1001/archpsyc.64.7.810.
- Background: PubMed 32235295Saeed SMU, Anwar SM, Khalid H, Majid M, Bagci AU. EEG based Classification of Long-term Stress Using Psychological Labeling. Sensors (Basel). 2020 Mar 29;20(7):1886. doi: 10.3390/s20071886.
- Background: PubMed 19226268Schoorlemmer RM, Peeters GM, van Schoor NM, Lips P. Relationships between cortisol level, mortality and chronic diseases in older persons. Clin Endocrinol (Oxf). 2009 Dec;71(6):779-86. doi: 10.1111/j.1365-2265.2009.03552.x. Epub 2009 Feb 18.
- BackgroundShute, V. J., Ventura, M., & Ke, F. (2015). The power of play: The effects of portal 2 and lumosity on cognitive and noncognitive skills. Computers & Education, 80, 58-67.
- Derived from this study: PubMed 39692236Valencia R, Anche G, Do Rego Barros G, Arostegui V, Sutaria H, McAllister E, Banihashem M, Volokitin M. Stressbusters: a pilot study investigating the effects of OMT on stress management in medical students. J Osteopath Med. 2024 Dec 19;125(5):261-267. doi: 10.1515/jom-2024-0020. eCollection 2025 May 1.
- 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?
A study testing Osteopathic Manipulative Medicine in people with Stress, Job and Student Burnout, 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 2 inclusion and 2 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 14 Nov 2023. 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?
Weekly Cortisol Level (time frame: Weekly, over the course of 8 week study). The study lists 3 primary outcomes in all. 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 NCT06125574, which also lists 10 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 14 Nov 2023.