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CTRI Number  CTRI/2025/07/090191 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [Music listening]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing Yoga Nidra and Veena Music on Mental Health of Young Adults 
Scientific Title of Study   A Comparative Multimodal Analysis of the Psychological Impacts of Yoga Nidra and Veena Music on Young Adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devika M 
Designation  PhD Scholar 
Affiliation  Manipal Institute of Technology, Manipal Academy of Higher Education 
Address  Department of Electronics and Communication, Manipal Institute of Technology, Udupi - Karkala Rd, Eshwar Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8300772607  
Fax    
Email  devika1.mitmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramya S 
Designation  Associate Professor 
Affiliation  Manipal Institute of Technology, Manipal Academy of Higher Education 
Address  Department of Electronics and Communication, Manipal Institute of Technology, Udupi - Karkala Rd, Eshwar Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9980947240  
Fax    
Email  ramya.lokesh@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Ramya S 
Designation  Associate Professor 
Affiliation  Manipal Institute of Technology, Manipal Academy of Higher Education 
Address  Department of Electronics and Communication, Manipal Institute of Technology, Udupi - Karkala Rd, Eshwar Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9980947240  
Fax    
Email  ramya.lokesh@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka- 576104, India 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Madhav Nagar, Manipal, Karnataka-576104, India 
Type of Sponsor  Other [Deemed to be University] 
 
Details of Secondary Sponsor  
Name  Address 
Devika M  Department of Electronics and Communication Engineering, Manipal Institute of Technology, Udupi - Karkala Rd, Eshwar Nagar, Manipal, Karnataka- 576104, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neetinakumar Patil  Manipal Academy of Higher Education  Room no.02, 1st floor, Division of Yoga, Dormitory building, Opp. to Artificial limb centre, Centre for Integrative Medicine and Research
Udupi
KARNATAKA 		 9886211008

patil.nj@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  Psychoeducation on the first session and no intervention for rest of the period of data collection  
Intervention  Music listening   A music listening module of veena instrumental rendition of raga mohana. The intervention would be provided for 3 days a week for 3 months. 
Intervention  Yoga Nidra  Yoga nidra, commonly known as yogic sleep, is a guided meditation technique. Yoga nidra developed by Swami Satyananda Saraswati, Bihar School of Yoga will be followed. It contains preparation for practice, resolve, rotation of consciousness, awareness of breath, feelings and sensations, visualization, and ending of practice. Intervention would be provided for 3 days a week for 3 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Students of constituent institutions of Manipal Academy of Higher Education, Manipal campus of the age range 18-30 years
2. A score of more than or equal to 13 in Perceived Stress Scale-10
3. Without prior formal training in yoga and music
4. Participants with yoga/music practice before 3 months of recruitment
 
 
ExclusionCriteria 
Details  1. Individuals who have attained professional music training or has undergone music therapy / yoga in the past 3 months
2. People with diagnosed physical and mental illnesses and under medication
3. People who are engaged in rigorous physical activity every day (activity for more than or equal to 1 hour a day)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Perceived Stress Scale-10, Electroencephalogram, Heart rate variability  Pre-intervention, 6 weeks, 12 weeks and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Positive and Negative Affect Schedule, Flanker task, N back task, Emotional face n back task  Pre-intervention, 6 weeks, 12 weeks and 24 weeks 
Vedic Personality Inventory  Pre-intervention and 24 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   15/07/2025 
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="2"
Months="5"
Days="16" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Considering the numeroud demands and challenges faced by the current generation which in turn leading to psychological issues, this study focuses on improving the well-being and functioning of individuals through non-invasive therapies. Young adults will undergo yoga and music-based interventions, with psychological variables such as stress, attention, working memory, and emotion being assessed. The study aims to enhance overall functioning through a feasible and non-invasive therapeutic approach. 
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