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CTRI Number  CTRI/2025/08/092747 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 09/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   Effect of sound-based meditation on stress among shift workers 
Scientific Title of Study   Effect of Nadanusandhana on psychological and physiological parameters of shift workers 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aman L 
Designation  MSc student 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA) 
Address  Swami Vivekananda Yoga Anusandhana Samsthana Vivekananda Road Kallabalu(Post) Jigani
Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA) Vivekananda Road Kallabalu(Post) Begaluru
Bangalore Rural
KARNATAKA
560105
India 
Phone  7878480441  
Fax    
Email  amanlk8235@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Nair 
Designation  Asst. Professor 
Affiliation  SVYASA 
Address  Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA) Vivekananda Road Kallabalu(Post) Begaluru

Bangalore Rural
KARNATAKA
560105
India 
Phone  9632164777  
Fax    
Email  rajeshnair@svyasa.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Nair 
Designation  Asst. Professor 
Affiliation  SVYASA 
Address  Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA) Vivekananda Road Kallabalu(Post) Begaluru


KARNATAKA
560105
India 
Phone  9632164777  
Fax    
Email  rajeshnair@svyasa.edu.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  SVYASA 
Address  Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA) Bengaluru 560105 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Basavaraj Gowda  Billforge clinic  CIE-Billforge pvt ltd Room No 3, HR department, Employee welfare division.
Bangalore Rural
KARNATAKA 		 8970002854

basavarajg23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) - SVYASA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nil 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nadanusandana  ‘A’, ‘U’, ‘M’, and ‘AUM’ chanting for 20 min. 5 days/ week for one month. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Shift workers, both male and female.
Age (20– 50 Years)
Willing to participate in research
Apparently healthy peoples.
 
 
ExclusionCriteria 
Details  Shift workers with any chronic medical condition.
Smoking or alcohol intake.
Any acute illness.
People with any disease. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Stress
Sleep Quality
Fatigue
Anxiety
Quality of Life
 		 Baseline and after one month 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   25/09/2025 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amanlk8235@gmail.com].

  6. For how long will this data be available start date provided 26-11-2025 and end date provided 25-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

In this study using a single-group pre-post design, we planned to investigate the effect of Nadanusandhana (a sound-based meditation technique) on the stress levels of the shift workers in a factory setting. A total of 48 participants of aged 20–50 years from IEC automotive, Bill Forge, Jigani, Bangalore, will be recruited; and will be provided 20 min of Nadanusandhana technique for 5 days/week for a month. The primary outcomes are Stress, Sleep Quality, Fatigue, Anxiety, Quality of Life.

 
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