| CTRI Number |
CTRI/2025/04/083938 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Influence of Sookshma Meditation on the Academic Performance, Autonomic Modulation, and Stress Levels in Medical Students |
|
Scientific Title of Study
|
Exploring the Effects of Sookshma Meditation on the Academic Performance, Autonomic Modulation, and Stress Levels in First-Year Medical Students in an Eastern Indian Private College |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VINAY A V |
| Designation |
Professor |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Physiology
Manipal Tata medical College
Kadani Road, Baridih, Jamshedpur
Purbi Singhbhum
JHARKHAND
831017
India |
| Phone |
9880966679 |
| Fax |
|
| Email |
vinay.av@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
VINAY A V |
| Designation |
Professor |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Physiology
Manipal Tata medical College
Kadani Road, Baridih, Jamshedpur
Purbi Singhbhum
JHARKHAND
831017
India |
| Phone |
9880966679 |
| Fax |
|
| Email |
vinay.av@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
VINAY A V |
| Designation |
Professor |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Physiology
Manipal Tata medical College
Kadani Road, Baridih, Jamshedpur
Purbi Singhbhum
JHARKHAND
831017
India |
| Phone |
9880966679 |
| Fax |
|
| Email |
vinay.av@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vinay A V |
| Address |
Manipal Tata Medical College, Kadani Road, Baridih, Jamshedpur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VINAY A V |
Manipal Tata Medical College |
Department of Physiology
Manipal Tata medical College
Kadani Road, Baridih, Jamshedpur
Purbi Singhbhum
JHARKHAND |
9880966679
vinay.av@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Sookshma Meditation |
Participants are made to practice sookshma meditation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Cases: 1st-year MBBS students within the age group of 18-25 years who have not practiced yoga or meditation before and are willing to participate in the study.
Controls: 1st year MBBS Students within the age group of 18-25 years who have not practiced yoga or meditation before and are willing to participate in the study.
Both Cases and controls will be academically matched
|
|
| ExclusionCriteria |
| Details |
The study will excluded individuals with chronic diseases such as hypertension and diabetes, chronic infections, or those taking antipsychotic medications. Additionally, chronic smokers, alcoholics, or drug addicts would not be included in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Conducting this study among the first-year MBBS students may help them quantify their stress levels as well as practicing meditation regularly may have a stress reduction impact. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Furthermore, this may help them perform better in their formative & summative assessments. |
4weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The performance of medical students in various assessments varies due to a myriad of factors. Before the implementation of Competency-based Medical Education (CBME), the teaching learning activities as well as the assessment methods mainly emphasized knowledge rather than skills. The contemporary curriculum of medical education is a multifaceted strategy that covers all aspects of attitude, communication, interdisciplinary teamwork, skills, and the capacity to implement evidence- and system-based care which is necessary to ensure the effective and efficient delivery of healthcare. Because of this, our assessment methods need to be comprehensive,
dependable, and robust enough to test for core knowledge and abilities in addition to evaluating these crucial traits.[1] Earlier to CBME, the evaluation of the medical students was primarily by way of summative assessment. With the implementation of CBME, the assessment methods have seen a new perspective in which formative assessments play a pivotal role in shaping the Indian Medical Graduate. Any assessment poses varying amounts of stress among students. Various studies by Stewart SM et al., (1999), Singh G et al., (2004), and Wilkisos TJ et al., (2006) reported that medical undergraduates encounter stress during their academic journey.[2,3,4] Stress that the student endures could stem from various sources. A study by Siraj HH et al., (2014) reported that high levels of stress were attributed to academic-related and social-related stressors.[5] Another study by Gupta S et al., (2015) ascribed the stress faced by medical students to primarily academic reasons.[6] The cognitive function of first-year medical students was found to be impaired as they face examinations as stressors, according to a study by Pradhan G et al., (2014). [7] Further, there is evidence of alterations in the sympatho vagal balance among the students due to stress. Heart rate variability (HRV) and mental stress have been the subject of numerous research, with a special emphasis on fluctuations in HRV among healthy university students during exam times. Stress disrupts the balance of the autonomic nervous system (ANS) with sympathetic dominance.[8] The coping mechanisms to overcome academic stress among medical students include various yoga and meditation practices.[9] However there is no evidence of the effect of Sookshma meditation on the coping levels of stress among medical students. It is essential to bridge the gap in literature regarding the effects of Sookshma meditation which may have a myriad of benefits for medical students, including enhancements in physical, psychological, emotional, and spiritual well-being as well as general health. |