NCT06125574

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

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

June 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 4, 2023

Last Update Submit

November 10, 2023

Conditions

Stress, JobStudent BurnoutStress, PhysiologicalStress, Psychological

Keywords

Osteopathic Manipulative MedicineOsteopathic Manipulative TreatmentOMMOMTCortisolMedical Student StressCognitive Function

Outcome Measures

Primary Outcomes (3)

  • Weekly Cortisol Level

    Salivary Cortisol as measured in an ELISA Immunoassay

    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.

    Weekly, over the course of 8 week study

  • LPI

    Learning Performance Index Metric from Lumosity

    Weekly, over the course of 8 week study

Study Arms (2)

Treatment

EXPERIMENTAL
Other: Osteopathic Manipulative Medicine

Control

NO INTERVENTION

Interventions

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.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-year medical students
  • Not currently receiving osteopathic manipulative treatment (OMT)

You may not qualify if:

  • Pregnant
  • History of spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Touro College of Osteopathic Medicine - Harlem

New York, New York, 10027, United States

Location

Related Publications (9)

  • Bath M, Owens J. Physiology, Viscerosomatic Reflexes. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559218/

    PMID: 32644644BACKGROUND

  • Degenhardt 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.

    PMID: 17908831BACKGROUND

  • Feldt 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.

    PMID: 18763455BACKGROUND

  • Licciardone 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.

    PMID: 22984233BACKGROUND

  • Licciardone 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.

    PMID: 32765058BACKGROUND

  • Lee 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.

    PMID: 17606815BACKGROUND

  • Saeed 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.

    PMID: 32235295BACKGROUND

  • Schoorlemmer 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.

    PMID: 19226268BACKGROUND

  • Shute, 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.

    BACKGROUND

MeSH Terms

Conditions

Occupational StressBurnout, PsychologicalStress, Psychological

Condition Hierarchy (Ancestors)

Occupational DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 4, 2023

First Posted

November 9, 2023

Study Start

June 15, 2023

Primary Completion

September 15, 2023

Study Completion

September 30, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)