Effect of Practicing Yoga and Meditation on Cortisol Hormone, Immunoglobulin a and Metabolic Parameter Among Medical Students (GSY)

This clinical trial aims to develop and test a yoga intervention to improve cortisol hormone rhythm, immunoglobulin A, and metabolic markers among medical students. The development of the yoga protocol, "GSY Goodbye Stress with Yoga Proto-col," was a collaborative effort involving a certified yoga trainer, medical researcher, and experienced yogis from India. GSY yoga intervention, which includes yoga asanas poses, breathing techniques, and guided meditation, may reduce stress levels, improve immunity, and enhance other metabolic parameters in medical students.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Adult Children
• Intervention / Treatment: Behavioral: GSY Yoga Intervention

Detailed Description

PRIMARY OBJECTIVE:

1. To examine the effectiveness of yoga intervention as a stress reduction technique and measure its effects on the level of cortisol, immunoglobulin A (IgA), and metabolic parameters.
2. To Compare the outcomes of a yoga intervention group to a non-yoga intervention group to determine whether practicing yoga can reduce the negative impacts of elevated cortisol on the physiological parameters.

SECONDARY OBJECTIVES:

1. To determine the correlation between the psychophysiological stress and cortisol hormone in students.
2. To investigate the effect of yoga intervention on student mental health and well-being.

OUTLINE:

Participants receive yoga intervention from a certified yoga trainer once a week for 10 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shalini Chauhan; Phone Number: +36-72/501-500/61682; Email: doktoriiskola@etk.pte.hu
• Study Contact Backup: Name: Shalini Chauhan; Phone Number: +36 (72) 513-678; Email: doktoriiskola@etk.pte.hu

Study Locations

• Hungary
  • Pécs, Hungary, 7621
    • Recruiting
    • University of Pecs
    • Contact: Viktória Prémusz; Phone Number: +36 (72) 513-678; Email: doktoriiskola@etk.pte.hu
    • Contact: Shalini Chauhan
    • Contact: Karsai István
    • Contact: Viktória Prémusz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

The inclusion criteria for the study required participants to be currently enrolled in the Medicine Faculty of the University of Pecs

Exclusion Criteria:

Students with illnesses (such as recent injuries, chronic pain, or significant arthritis) that would make it unsafe for them to take part in a yoga intervention will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSY Yoga Intervention; GSY Goodbye Stress with Yoga Protocol Full body warm-up and light stretching exercise 15 min Performing various yoga postures - including standing, sitting, prone, and supine yoga postures (Asanas) 50 min Breathing exercises = (Pranayama)10 min and Meditation15 min *The development of the yoga protocol, named "GSY Goodbye Stress with Yoga Protocol," was a collaborative effort involving a certified yoga trainer, a medical researcher, and experienced yogis from India.	Behavioral: GSY Yoga Intervention; In the GSY yoga intervention, where participants received 90 minutes/week yoga intervention for duration of 10 weeks.
No Intervention: Control Group; The participants who don't receive any kind of therapy, which means the control group with standard care and without any treatment or intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of GSY Yoga Intervention in the Improvement of Immunoglobulin A among Medical Students	Samples of saliva cortisol will be collected to analyse diurnal cortisol rhythm , at the beginning and the end of the first and the last yoga class to determine immediate and longitudinal effects and to measure the diurnal rhythms of immunoglobulin.	upto 10 weeks
Efficacy of GSY yoga intervention in the reduction of cortisol hormone rhythm	Samples of saliva cortisol will be collected, at the beginning and the end of the first and the last yoga class to determine immediate and longitudinal effects and to measure the diurnal rhythms of cortisol.	upto 10 weeks
Efficacy of GSY yoga intervention in the cortisol hormone by using hair cortisol concentration	Samples of hair cortisol will be collected to measure hair cortisol concentration for analyzing the long-term cortisol level in individuals, at the beginning and the end of the first and the last yoga class	10 weeks
Effect of 10 weeks yoga intervention on immune and metabolic parameter among medical students	Blood sample will be collected to analyse Immune parameter, including Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, and Metabolic parameter including, Fasting Blood Glucose FBG, HBA1C, LDL,HDL,total cholesterol, triglycerides, and non-HDL at the beginning and the end of the first and the last yoga class to determine immediate and longitudinal effects. .	Upto 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Quality of life	The change in the quality of life before and after yoga intervention is measured by collecting data from participants using the WHOQOL (World Health Organization Quality of Life-Bref) tool. The WHOQOL-Bref, a shorter version of the WHOQOL-100, provides a comprehensive measure of quality of life across four domains: physical health, psychological health, social relationships, and environment. Scores for each domain range from 0 to 100, with higher scores indicating a better quality of life.	upto 10 weeks
Changes in sleep quality	The change in sleep quality before and after the yoga intervention is measured by collecting data from participants using the Pittsburgh Sleep Quality Index (PSQI). The PSQI scores range from 0 to 21, with higher scores indicating worse sleep quality.	upto 10 weeks
Changes in physical activity	The change in physical activity level before and after the yoga intervention is measured by collecting data from participants using the Global Physical Activity Questionnaire (GPAQ). This tool presents physical activity as a separate outcome measure. the GPAQ scores range in MET( Metabolic Equivalent of Task)-minutes per week, with higher scores indicating higher levels of physical activity.	upto 10 weeks
Changes in stress reduction	The change in stress levels before and after the yoga intervention is measured by collecting data from participants using the Depression, Anxiety, and Stress Scales (DASS). The DASS scores range from 0 to 42 for each subscale (Depression, Anxiety, Stress), with higher scores indicating greater severity of symptoms.	upto 10 weeks
Changes in emotional regulation	The change in emotional regulation before and after yoga intervention is measured by collecting data from participants using the DERS (The Difficulties in Emotion Regulation Scale). DERS is an instrument measuring emotion regulation problems. tool.	upto 10 weeks
Changes in Sedentary Behaviour	The changes in the sedentary behavior of the participants before and after the yoga intervention will be analyzed by using the Sedentary Behavior Questionnaire (SBQ).	Upto 10 weeks

Collaborators and Investigators

• Sponsor: University of Pecs
• Investigators: Principal Investigator: Shalini Chauhan, Assistant Professor, PhD student University of Pécs

Publications and helpful links

General Publications

• Chauhan S, Babu AM, Galgalo DA, Melczer C, Premusz V, Karsai I. Effect of yoga in medical students to reduce the level of depression, anxiety, and stress: pilot study (Goodbye Stress with Yoga GSY). BMC Complement Med Ther. 2024 May 24;24(1):203. doi: 10.1186/s12906-024-04496-0.

Helpful Links

• Pilot Study Results

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 23, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Yoga; mental health; Immunoglobulin; Medical students; Cortisol Hormone
• Other Study ID Numbers: GSY (Goodbye Stress with Yoga)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No