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

Sponsor
The Touro College and University System (Other)
Overall Status
Completed
CT.gov ID
NCT06125574
Collaborator
(none)
10
1
2
3.5
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Osteopathic Manipulative Medicine
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Regular OMT on Stress Levels and Cognitive Function in OMS-I Students at Touro COM-NY Harlem
Actual Study Start Date :
Jun 15, 2023
Actual Primary Completion Date :
Sep 15, 2023
Actual Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Weekly Cortisol Level [Weekly, over the course of 8 week study]

    Salivary Cortisol as measured in an ELISA Immunoassay

  2. College Student Subjective Stress Survey (CSSS) Numerical Score [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.

  3. LPI [Weekly, over the course of 8 week study]

    Learning Performance Index Metric from Lumosity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • First-year medical students

  • Not currently receiving osteopathic manipulative treatment (OMT)

Exclusion Criteria:
  • Pregnant

  • History of spinal surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Touro College of Osteopathic Medicine - Harlem New York New York United States 10027

Sponsors and Collaborators

  • The Touro College and University System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mikhail Volokitin, MD, DO., Assistant Professor, The Touro College and University System
ClinicalTrials.gov Identifier:
NCT06125574
Other Study ID Numbers:
  • 18777
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mikhail Volokitin, MD, DO., Assistant Professor, The Touro College and University System
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2023