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NCT Number: NCT06661603

Effect of Practicing Yoga and Meditation on Cortisol Hormone, Immunoglobulin A and Metabolic Parameter Among Medical Students

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pécs

Pécs, 7621, Hungary

Location status: Recruiting

Location contact

Karsai István

SUB_INVESTIGATOR

Shalini Chauhan

PRINCIPAL_INVESTIGATOR

Viktória Prémusz

CONTACT

[email protected]

+36 (72) 513-678

Viktória Prémusz

SUB_INVESTIGATOR

About this study

PRIMARY OBJECTIVE:

  • 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.
  • 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:

  • To determine the correlation between the psychophysiological stress and cortisol hormone in students.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSY Yoga Intervention

Behavioral

In the GSY yoga intervention, where participants received 90 minutes/week yoga intervention for duration of 10 weeks.

Primary outcomes

  1. Effect of GSY Yoga Intervention in the Improvement of Immunoglobulin A among Medical Students

    Time frame: upto 10 weeks

    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.

  2. Efficacy of GSY yoga intervention in the reduction of cortisol hormone rhythm

    Time frame: upto 10 weeks

    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.

  3. Efficacy of GSY yoga intervention in the cortisol hormone by using hair cortisol concentration

    Time frame: 10 weeks

    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

  4. Effect of 10 weeks yoga intervention on immune and metabolic parameter among medical students

    Time frame: Upto 10 weeks

    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. .

Secondary outcomes

  1. Changes in Quality of life

    Time frame: upto 10 weeks

    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.

  2. Changes in sleep quality

    Time frame: upto 10 weeks

    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.

  3. Changes in physical activity

    Time frame: upto 10 weeks

    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.

  4. Changes in stress reduction

    Time frame: upto 10 weeks

    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.

  5. Changes in emotional regulation

    Time frame: upto 10 weeks

    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.

  6. Changes in Sedentary Behaviour

    Time frame: Upto 10 weeks

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Shalini Chauhan

CONTACT

[email protected]

+36-72/501-500/61682

Shalini Chauhan

CONTACT

[email protected]

+36 (72) 513-678

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Acronym: GSY

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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