Clinical trial NCT06661603: Effect of Practicing Yoga and Meditation on Cortisol Hormone, Immunoglobulin a and Metabolic Parameter Among Medical Students
Official title: Effect of Practicing Yoga and Meditation on Cortisol Hormone, Immunoglobulin a and Metabolic Parameter Among Medical Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Adult Children
Keywords: Medical students
Yoga
Cortisol Hormone
Immunoglobulin
mental health
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of GSY Yoga Intervention in the Improvement of Immunoglobulin A among Medical Students
timeFrame: upto 10 weeks
measure: Efficacy of GSY yoga intervention in the reduction of cortisol hormone rhythm
timeFrame: upto 10 weeks
measure: Efficacy of GSY yoga intervention in the cortisol hormone by using hair cortisol concentration
timeFrame: 10 weeks
measure: Effect of 10 weeks yoga intervention on immune and metabolic parameter among medical students
timeFrame: Upto 10 weeks
Secondary outcomes:
measure: Changes in Quality of life
timeFrame: upto 10 weeks
measure: Changes in sleep quality
timeFrame: upto 10 weeks
measure: Changes in physical activity
timeFrame: upto 10 weeks
measure: Changes in stress reduction
timeFrame: upto 10 weeks
measure: Changes in emotional regulation
timeFrame: upto 10 weeks
measure: Changes in Sedentary Behaviour
timeFrame: Upto 10 weeks
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs
Study officials:
affiliation: Assistant Professor, PhD student University of Pécs
name: Shalini Chauhan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.