Clinical trial NCT06125574: Investigating the Effects of Osteopathic Manipulative Treatment on Stress Management in Medical Students
Official title: The Effects of Regular OMT on Stress Levels and Cognitive Function in OMS-I Students at Touro COM-NY Harlem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Job
Student Burnout
Stress, Physiological
Stress, Psychological
Keywords: Osteopathic Manipulative Medicine
Osteopathic Manipulative Treatment
OMM
OMT
Cortisol
Medical Student Stress
Cognitive Function
Lead sponsor: The Touro College and University System
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant
* History of spinal surgery

Primary outcomes:
measure: Weekly Cortisol Level
timeFrame: Weekly, over the course of 8 week study
measure: College Student Subjective Stress Survey (CSSS) Numerical Score
timeFrame: Weekly, over the course of 8 week study
measure: LPI
timeFrame: Weekly, over the course of 8 week study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Touro College of Osteopathic Medicine - Harlem
state: New York
Study officials:
References:
citation: 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/
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citation: 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.
citation: 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.
citation: 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.