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CTRI Number  CTRI/2024/03/063815 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Effect of Cyclic Meditation on Female Nursing Students 
Scientific Title of Study   Effect of Cyclic Meditation on Psychophysiological Variables, Oxidative Stress, and Spiritual Well-Being of Female Nursing Students 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAHUL  
Designation  Research Scholar 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Room No. 101, Boys, Hostel, Yoga & Spirituality Department, Prashanti Kutiram, Vivekananda Road, Kallubalu Post, Jigani, Anekal Taluk, Bengaluru-560105
Prashanti Kutiram, Vivekananda Road, Kallubalu Post, Jigani, Anekal Taluk, Bengaluru-560105
Bangalore
KARNATAKA
560105
India 
Phone  09560524204  
Fax    
Email  rahularyasvyasa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Divya B.R. 
Designation  Assistant Professor  
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Yoga & Spirituality Department, Prashanti Kutiram, Vivekananda Road, Kallubalu Post, Jigani, Anekal Taluk, Bengaluru-560105
Prashanti Kutiram, Vivekananda Road, Kallubalu Post, Jigani, Anekal Taluk, Bengaluru-560105
Bangalore
KARNATAKA
560105
India 
Phone  9590010199  
Fax    
Email  divya.keshav@svyasa.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr. Hemant Bhargav 
Designation  Associate Professor 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Department of Integrative Medicine, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, India
National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, India
Bangalore
KARNATAKA
560029
India 
Phone  8762019348  
Fax    
Email  drbhargav.nimhans@gmail.com  
 
Source of Monetary or Material Support  
Anveshana Laboratory, S-VYASA University, Bangalore, India  
 
Primary Sponsor  
Name  Self 
Address  Yoga and Spirituality Department, Prashanti Kutiram, SVYASA University, Vivekananda Road, Kallubalu Post Jigani, Anekal Taluk, Bengaluru-560105, Inida Bangalore KARNATAKA 
Type of Sponsor  Other [Self Funded by the Researcher] 
 
Details of Secondary Sponsor  
Name  Address 
Maharshi Dayanand Yoga Society  667/25, Bhisamber Nagar, Rohtak Road, Jind, Haryana- 126102 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya BR  Swami Vivekananda Yoga Anusandhana Samsthana  Yoga and Spirituality Department, Prashanti Kutiram, SVYASA University, Vivekananda Road, Kallubalu Post Jigani, Anekal Taluk, Bengaluru-560105, Inida
Bangalore
KARNATAKA 		 9590010199

divya.keshav@svyasa.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee (IEC) of Swami Vivekananda Yoga Anusandhana Samsthana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sushruta Nursing College, Bengalore, Healthy Female Nursing Students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cyclic Meditation (CM)  Previous studies including a review article show that Cyclic Meditation (CM) is a good relaxation exercise and affects psychophysiological states positively. (P. Sarang & Telles, 2006; Subramanya & Telles, 2009) The experimental group will practice 35 min of CM practice regularly 3 days a week for 12 weeks. A female CM expert instructor will give intervention. During Menstruation, only DRT and Supine Rest will be performed  
Comparator Agent  Waitlist Control Group  Cyclic Meditation After completing the follow-up data then will provide Cyclic Meditation classes to waitlist control group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Healthy females from nursing courses aged 18-25 years.

Subjects having no prior experience with CM.

Participants willing to give consent will be part of the study.
 
 
ExclusionCriteria 
Details  Male nursing students (WHO, 2021).

Intake of medications that are known to influence cognitive or autonomic functions or mental health.

Participants who are addicted to smoking, alcohol, or any other substances (Pan et al., 2019).

Pregnant or lactating participants will be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Psychophysiological Variables: Heart Rate Variability using Electrocardiogram (ECG),
Visuospatial Working Memory using Corsi Block Tabbing Task (CBTT)

Stress-Anxiety-Depression using Depression Anxiety Stress Questionnaire-21 (DASS-21),

Quality of Sleep using Pittsburgh Sleep Quality Index (PSQI) 		 Pre-Assessment (0 Weeks)
Post-Assessment (12 Weeks)
Follow-up (18 Weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Biochemical Changes (Oxidative Stress) using the Biomarkers MDA (Malondialdehyde) & GSH (Reduced Glutathione)

Spiritual Well-Being (Spirituality Level) using Spiritual Well-Being Scale (SWBS)

Prakriti (Vatta, Pitta, Kapha) using AyuSoft Questionnaire & Gunas (Sattva, Tamas, Rajas) using Vedic Personality Inventory (VPI) 		 Pre-Assessment (0 Weeks)
Post-Assessment (12 Weeks)
Follow-up (18 Weeks) 
 
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)   15/03/2024 
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="5"
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
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response - None of the above

  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 - Data are available indefinitely at (Link to be included SVYASA UNIVERSITY).

  6. For how long will this data be available start date provided 15-03-2024 and end date provided 15-08-2024?
    Response - Immediately following publication. No end date.

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

The present study aims to focus on the effect of 12 weeks of CM practice on psychophysiological variables, oxidative stress, and spiritual well-being of nursing students. Several studies have assessed the short-term effect of CM on psychophysiology. However, there are no reports of CM on oxidative stress markers and spiritual well-being. To the best of our knowledge, no study has investigated the long-term effect of CM.

HYPOTHESIS AND NULL HYPOTHESIS

CM is a moving meditation and one of the best mind-body relaxing practices. As per previous studies, it was seen that the Immediate effect of CM practice helps to reduce stress, anxiety, and depression and enhance concentration, memory, and sleep quality. Two studies were conducted on the one-month practice of CM (Dahal & Pradhan, 2018.; Varghese et al., 2018b) on stress, anxiety, and depression, To the best of my knowledge, not a single study conducted on 12 weeks CM practice. We hypothesize that CM is a good relaxation technique and it may be useful for the students to reduce their burnout, stress, anxiety, and stress if they practice it regularly.  
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