Investigating the Effects of Osteopathic Manipulative Treatment on Stress Management in Medical Students

Stress, Psychological Clinical Trial

Official title:

The Effects of Regular OMT on Stress Levels and Cognitive Function in OMS-I Students at Touro COM-NY Harlem

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06125574
• Other study ID #: 18777
• Status: Completed
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: The Touro College and University System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First-year medical students

• Not currently receiving osteopathic manipulative treatment (OMT)

Exclusion Criteria:

• Pregnant

• History of spinal surgery

Related Conditions & MeSH terms

• Burnout, Psychological
• Occupational Stress
• Stress, Physiological
• Stress, Psychological

Intervention

Other:
• Osteopathic Manipulative Medicine
Individuals in the experimental cohort will undergo a systematic osteopathic manipulative treatment protocol encompassing paraspinal inhibition, rib raising, and condylar decompression techniques.

Locations

Country	Name	City	State
United States	Touro College of Osteopathic Medicine - Harlem	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The Touro College and University System

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Am Osteopath Assoc. 2017 Jun 1;117(6):350. — View Citation

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. — View 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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly Cortisol Level	Salivary Cortisol as measured in an ELISA Immunoassay	Weekly, over the course of 8 week study
Primary	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
Primary	LPI	Learning Performance Index Metric from Lumosity	Weekly, over the course of 8 week study