HealthyGSYNCT06661603
Effect of Practicing Yoga and Meditation on Cortisol Hormone, Immunoglobulin A and Metabolic Parameter Among Medical Students
A study testing GSY Yoga Intervention in people with Healthy and Adult Children, run by University of Pecs at 1 site in Hungary.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Adult Children
- What is being tested?
- GSY Yoga Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteHungary
- Study dates
- 7 Feb 2022to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The inclusion criteria for the study required participants to be currently enrolled in the Medicine Faculty of the University of Pecs
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
University of Pécs
Pécs, Pécs, 7621
Viktória Prémusz, +36 (72) 513-678, doktoriiskola@etk.pte.hu
Shalini Chauhan
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy, Adult Children
- Being tested
- GSY Yoga Intervention
- Keywords
- Medical students, Yoga, Cortisol Hormone, Immunoglobulin, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSY Yoga InterventionBehavioural
In the GSY yoga intervention, where participants received 90 minutes/week yoga intervention for duration of 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| GSY Yoga Intervention | Experimental | 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. Receives: Behavioral: GSY Yoga Intervention |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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. .
Measured: Upto 10 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Upto 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start7 Feb 2022
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shalini Chauhan, Principal investigator, Assistant Professor, PhD student University of Pécs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661603
- Sponsor's protocol ID
- GSY (Goodbye Stress with Yoga)
- Acronym
- GSY
- Status last verified
- Oct 2024
- First submitted
- 23 Jun 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38790041Chauhan S, Najaf SS, Nagy Z, Al-Jawarneh M, Nagy T, Miseta A, Premusz V, Karsai I. An exploratory study on the changes in immune and metabolic parameters by 10 weeks of yoga intervention among medical students. Sci Rep. 2025 Nov 5;15(1):38730. doi: 10.1038/s41598-025-22421-4.
PubMed 41193511Chauhan S, Najaf SS, Lukacs G, Kinga KA, Karsai I, Premusz V. Impact of 10 Weeks of Yoga Intervention on Mental Health and Overall Well-Being Among Medical Students: GSY Study. Sports (Basel). 2025 Apr 10;13(4):114. doi: 10.3390/sports13040114.
PubMed 40278740
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Practicing Yoga and Meditation on Cortisol Hormone, Immunoglobulin A and Metabolic Parameter Among Medical Students
- ClinicalTrials.gov ID
- NCT06661603
- Acronym / sponsor ID
- GSY / GSY (Goodbye Stress with Yoga)
- Conditions
- Healthy, Adult Children
- Keywords
- Medical students, Yoga, Cortisol Hormone, Immunoglobulin, mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSY Yoga Intervention | Experimental | Behavioral: GSY Yoga InterventionGSY 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. |
| Control Group | No intervention | –The participants who don't receive any kind of therapy, which means the control group with standard care and without any treatment or intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The inclusion criteria for the study required participants to be currently enrolled in the Medicine Faculty of the University of Pecs
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSY Yoga InterventionIn the GSY yoga intervention, where participants received 90 minutes/week yoga intervention for duration of 10 weeks. | Behavioural | GSY Yoga Intervention |
Primary outcome
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.
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.
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
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. .
6 secondary outcomes
Changes in Quality of life
Time frame: upto 10 weeks
Changes in sleep quality
Time frame: upto 10 weeks
Changes in physical activity
Time frame: upto 10 weeks
Changes in stress reduction
Time frame: upto 10 weeks
Changes in emotional regulation
Time frame: upto 10 weeks
Changes in Sedentary Behaviour
Time frame: Upto 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Results publication: PubMed 38790041Chauhan 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.
- Derived from this study: PubMed 41193511Chauhan S, Najaf SS, Nagy Z, Al-Jawarneh M, Nagy T, Miseta A, Premusz V, Karsai I. An exploratory study on the changes in immune and metabolic parameters by 10 weeks of yoga intervention among medical students. Sci Rep. 2025 Nov 5;15(1):38730. doi: 10.1038/s41598-025-22421-4.
- Derived from this study: PubMed 40278740Chauhan S, Najaf SS, Lukacs G, Kinga KA, Karsai I, Premusz V. Impact of 10 Weeks of Yoga Intervention on Mental Health and Overall Well-Being Among Medical Students: GSY Study. Sports (Basel). 2025 Apr 10;13(4):114. doi: 10.3390/sports13040114.
- Pilot Study ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Chauhan principal investigator
Assistant Professor, PhD student University of Pécs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GSY Yoga Intervention in people with Healthy and Adult Children, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shalini Chauhan (+36-72/501-500/61682, doktoriiskola@etk.pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of GSY Yoga Intervention in the Improvement of Immunoglobulin A among Medical Students (time frame: upto 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06661603, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.