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CTRI Number  CTRI/2025/01/078996 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [Sound based meditation]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   An observation of Meditation along with Harmonious sounds promotes mental well-being in human population. 
Scientific Title of Study   Effects of Sound-based Meditative Healing Method on Stress, Tension, Cortisol Levels & Blood Pressure 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SURESH SATHYANARAYANAN 
Designation  ASSOCIATE SCIENTIST 
Affiliation  UNS RESEARCH COUNCIL 
Address  ROOM NO 01 DIRECTOR OF OBSERVATIONAL STUDIES UNS RESEARCH COUNCIL

Dharmapuri
TAMIL NADU
635110
India 
Phone  8610130617  
Fax    
Email  sureshsathyanarayanan3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR HEMACHANDRAN RAVIKUMAR 
Designation  RESEARCH SCIENTIST 
Affiliation  N&H Research Park 
Address  ROOM NO 1 Clinical Trial and Registrations Division, Department of Medical Sciences, N&H Research Park

Chennai
TAMIL NADU
600095
India 
Phone  7305012042  
Fax    
Email  chandru07x@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR HEMACHANDRAN RAVIKUMAR 
Designation  RESEARCH SCIENTIST 
Affiliation  N&H Research Park 
Address  ROOM NO 1 Clinical Trial and Registrations Division, Department of Medical Sciences, N&H Research Park

Chennai
TAMIL NADU
600095
India 
Phone  7305012042  
Fax    
Email  chandru07x@gmail.com  
 
Source of Monetary or Material Support  
UNS Digital Technologies pvt Ltd H-25, Thally Road, Old ASTC HUDCO, Hosur, Krishnagiri, Tamil Nadu, 635109 INDIA  
 
Primary Sponsor  
Name  UNS Digital Technologies Pvt LTD  
Address  H-25, Thally Road, Old ASTC HUDCO, Hosur, Krishnagiri, Tamil Nadu, 635109 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Denmark
Estonia
Finland
France
Georgia
Germany
Iceland
India
Ireland
Italy
Latvia
Luxembourg
Malaysia
Myanmar
Nepal
New Zealand
Nigeria
Norway
Poland
Singapore
South Africa
Spain
Sri Lanka
Sweden
Switzerland
Thailand
United Arab Emirates
United Kingdom
United States of America  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemachandran Ravikumar  UNS Health Care   UNS Health Care(An Unit of UNS Research Council), Department of Ayush, Room No 1, Ayush Division,H-25, Thally Road, Old ASTC HUDCO Krishnagiri, Pincode - 635109
Dharmapuri
TAMIL NADU 		 7305012042

chandru07x@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
UNS RESEARCH COUNCIL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: F09||Unspecified mental disorder due toknown physiological condition, (3) ICD-10 Condition: F29||Unspecified psychosis not due to asubstance or known physiological condition, (4) ICD-10 Condition: F348||Other persistent mood [affective]disorders, (5) ICD-10 Condition: F411||Generalized anxiety disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Non Sound Based Meditation   Group Size: 50 participants Meditation Schedule: Attended meditation once daily at the centre during controlled batch time slots. Restrictions: No additional self-meditation outside of the scheduled sessions. Environment: Participated in the same meditation space but without the added intervention of self-guided meditation at home. Duration: Approximately 60 minutes per session. 
Intervention  Sound based meditation  Group Size: 50 participants Meditation Schedule: Attended daily sound-based meditation sessions at the centre during allotted time slots (same as the control group). Additional self-meditation at home or in silent spaces for 20 minutes in the morning and 20 minutes at night using prerecorded 528 Hz sound frequencies. Guidelines: Avoid emotional conflicts, harsh arguments, and late-night activities. Follow a vegan diet for easier digestion. Maintain a calm state throughout the trial. Environment: Home-based meditation in addition to the structured sessions at the centre. Duration: Centre-based meditation for 60 minutes daily + 40 minutes of self-meditation at home (split into morning and night). Equipment: Singing bowls, crystal bowls, bells, and gongs were used alongside the recorded 528 Hz solfeggio frequency. Freedom to Withdraw: Participants could withdraw by submitting a withdrawal letter to the principal investigator. The intervention group receives an enhanced form of sound-based meditation by incorporating daily self-meditation practices at home with prerecorded sounds, making it distinct from the control group, which participates only in centre-based sessions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  1. Individuals with no severe physical or mental health conditions that could hinder meditation practices.
2. Participants who can maintain calmness, avoid conflicts, and adhere to the lifestyle modifications required by the study. 
 
ExclusionCriteria 
Details  1. Individuals with severe psychiatric disorders (e.g., schizophrenia, major depression).
2.Those with uncontrolled physical conditions that prevent participation (e.g., chronic pain, cardiovascular disease). 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Reduction in Stress, Tension, and Anxiety Levels
2.Measured through the Hospital Anxiety and Depression Scale (HADS) for anxiety and depression.
3.Profile of Mood States (POMS-SF) used to evaluate changes in tension, anger, and overall mood. 		 30 DAYS  
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in Anger and Emotional Distress  30 DAYS  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   31/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/01/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="11"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 30-12-2024 and end date provided 01-12-2025?
    Response - Immediately following publication. No end date.

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

This randomized controlled trial (RCT) investigated the effects of sound-based meditation using Solfeggio frequencies (528 Hz), singing bowls, gongs, and bells on stress, anxiety, tension, blood pressure, and cortisol levels. The trial involved 100 participants (50 in the control group and 50 in the experimental group) over four weeks at the UNS Research Council in Tamil Nadu, India.

Expected Key Findings:

  • Experimental Group:
    • Showed significant reductions in anxiety, depression, tension, and cortisol levels (p < 0.001).
    • Participants experienced improvements in mood, spiritual well-being, and blood pressure.
  • Control Group (Placebo Meditation):
    • No significant changes (p > 0.05) in stress, anxiety, or physiological parameters were demonstrated.

Expected Outcome Measures:

  • Primary Outcome: Reduction in stress, anxiety, and depression (measured via HADS and POMS-SF).
  • Secondary Outcomes:
    • Lowered cortisol levels.
    • Blood pressure significantly decreased.
    • Enhanced spiritual and emotional well-being.

Methodology:

  • Participants attended daily 60-minute meditation sessions. The experimental group also engaged in self-meditation at home with recorded sound frequencies.
  • Assessments included blood pressure measurements, cortisol level tests, and self-reported psychological scales (HADS, POMS-SF).

Authors:

  • Dr. Hemachandran Ravikumar, MRSB, Rsci (UK)
  • Mr. Suresh Sathyanarayanan
 
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