| CTRI Number |
CTRI/2025/12/098884 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sound-Based Meditation for Reducing Exam Stress and Enhancing Mental Health |
|
Scientific Title of Study
|
Alleviating Examination Stress Through Sound Meditation-Based Lifestyle Intervention: Impacts on Monoamines and Mental Health in a Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Megha Pundir |
| Designation |
Ph.D Scholar |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Room no-6, Psychology lab, Central University of Rajasthan, Ajmer, Rajasthan-305817, India
Ajmer
RAJASTHAN
305817
India |
| Phone |
08218172780 |
| Fax |
|
| Email |
meghapundeer20899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjib Patra |
| Designation |
Professor, HOD |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Room no- 6, Psychology lab, Central University of Rajasthan, Ajmer, Rajasthan-305817, India
Ajmer
RAJASTHAN
305817
India |
| Phone |
|
| Fax |
|
| Email |
sanjib.patra@curaj.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Shanker Yadav |
| Designation |
PhD scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Yoga, Room no- 6, Psychology lab, Central University of Rajasthan, Ajmer, Rajasthan-305817, India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09455050889 |
| Fax |
|
| Email |
VIJAYSHANKERAHIR89@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Department of Yoga, Room no- 6, Psychology lab, Central University of Rajasthan, Ajmer, Rajasthan-305817, India |
|
|
Primary Sponsor
|
| Name |
Central University of Rajasthan |
| Address |
Central University of Rajasthan, Bandarsindri, Ajmer, 305817, Idia |
| Type of Sponsor |
Other [Central University] |
|
|
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 |
| Sanjib Patra |
Central University of Rajasthan |
Department of Yoga, Room no-6, Physiology Lab, Central University of Rajasthan, Ajmer, Rajasthan-305817, India
Ajmer
RAJASTHAN |
8171706983
sanjib.patra@curaj.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1st group- Meditation |
focus on specific sound, 8 Weeks |
| Comparator Agent |
2nd Group- Wait list Control |
No Intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Participant
Able to do Yoga and Meditation
Willing to participate |
|
| ExclusionCriteria |
| Details |
Who Taken any type of Drug
Not able to meditate
Any Severe condition of disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serotonin
Dopamine
epinephrine
norepinephrine |
2 times , first and after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Psychological well-being sleep quality |
2 times , first and after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/12/2025 |
| 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="0"
Months="1"
Days="26" |
|
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
|
Alleviating Examination Stress Through Sound Meditation-Based Lifestyle Intervention: Impacts on Monoamines and Mental Health in a Randomized Controlled Study
Background: Academic stress among university students is an escalating public health issue, with implications for mental health and neurophysiological balance. Exam-related stress can disrupt neurotransmitter balance, affecting mood, cognition, and stress responses. Non-pharmacological interventions, particularly contemplative practices such as meditation, offer holistic avenues for enhancing both psychological and biochemical well-being. Objective: This study aimed to evaluate the effects of an 8-week Sound-Meditation-Based Lifestyle Intervention on monoamine neurotransmitter levels and psychological health in university students with self-reported exam stress. Methods: In a randomized controlled trial, 37 students (aged 18–25) were assigned to either intervention group (n = 18) or waitlist control group (n = 19). The intervention consisted of daily Nadamay (sound-based) meditation, weekly spiritual counselling, and lifestyle regulation through evening walks. Pre- and post-intervention assessments included serum levels of dopamine, serotonin, epinephrine, and norepinephrine, along with psychological outcomes, exam stress, sleep quality, depression, anxiety, and stress. Results: The intervention group showed a significant increase in dopamine (p=0.002) and reductions in epinephrine (p=0.003) and norepinephrine (p<0.001) levels. Psychologically, significant improvements were observed in exam stress, depression, anxiety, stress, and sleep quality (all p<0.001). No significant changes occurred in the control group. Conclusion: The Sound-Meditation-Based Lifestyle Intervention effectively improved monoaminergic function and psychological well-being in students facing academic stress. These effects likely stem from integrated modulation of neuroendocrine systems through contemplative practice, emotional processing, and physical activity. Keywords: Sound meditation; Monoamine neurotransmitters; Exam stress; Spiritual counselling; University students. |