| CTRI Number |
CTRI/2024/10/075214 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Short-duration meditation can influence our mind and body |
|
Scientific Title of Study
|
A study on the effect of short-duration meditation on human physiology |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suvendra Kumar Ray |
| Designation |
Professor |
| Affiliation |
Tezpur University |
| Address |
Department of Molecular Biology and Biotechnology, Tezpur University, Napaam, Tezpur, Assam
Sonitpur
ASSAM
784028
India |
| Phone |
|
| Fax |
|
| Email |
suven@tezu.ernet.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Anurag Jayswal |
| Designation |
Research Scholar |
| Affiliation |
Tezpur University |
| Address |
Department of Molecular Biology and Biotechnology, Tezpur University, Napaam, Tezpur, Assam
Sonitpur
ASSAM
784028
India |
| Phone |
07037418146 |
| Fax |
|
| Email |
mbp21005@tezu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Anurag Jayswal |
| Designation |
Research Scholar |
| Affiliation |
Tezpur University |
| Address |
Department of Molecular Biology and Biotechnology, Tezpur University, Napaam, Tezpur, Assam
Sonitpur
ASSAM
784028
India |
| Phone |
07037418146 |
| Fax |
|
| Email |
mbp21005@tezu.ac.in |
|
|
Source of Monetary or Material Support
|
| Tezpur University, Napaam-784028, Assam, Bharat |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [It is under university PhD program] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhabesh Deka |
Tezpur University |
Department of Electronics and Communication Engineering, Room No. 305
Sonitpur
ASSAM |
7002653403
bdeka@tezu.ac.in |
| Dr Suvendra Kumar Ray |
Tezpur University |
Department of Molecular Biology and Biotechnology, Room No. 120
Sonitpur
ASSAM |
9954472151
suven@tezu.ernet.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tezpur University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants will be healthy students and faculty members who will join for meditation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mind body relaxation
rejuvenation technique |
It is an easy-to-follow mind-body technique validated by experts. With each exhalation, thumb movement on finger divisions is done. Meditation will be given for 10 minutes in a session. The number of sessions will be according to the participants choice. Our minimum and maximum session criteria are 1-5. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy nonmeditators with no history of neurological and psychological abnormalities. |
|
| ExclusionCriteria |
| Details |
Persons with any psychological issues, neurological abnormalities, or other serious disorders, and unable to perform meditation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
(i)This study will scientifically validate a short-duration mind-body relaxation rejuvenation technique.
(ii)This study will find out the nap and calm effects and its neural correlation.
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will suggest the importance of cognitive relaxation and rejuvenation in academics and workplaces. It will suggest promoting self regulative behavior among people. |
7-8 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
25/10/2024 |
| 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="8"
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 - NO
|
|
Brief Summary
|
Meditation is a self-care method for well-being. It has several
psychological and physiological benefits as reported till yet. However, the nap-related psycho-physiological effect of a short-duration meditation intervention is unexplored. It is hypothesized that a mind-body technique can induce a nap. Neural
correlates of meditation may suggest related evidence of this. The proposed
meditation method, which is a simple breath and thumb movement coordination while
sitting in a chair comfortably is based on an ancient karmala-based
technique. It may be helpful in relaxation
and rejuvenation by inducing a nap which may be beneficial for people in academics and workplaces. A real-time Electroencephalogram (EEG)
assessment will be done for objective confirmation. We want to investigate
whether the proposed meditative method (named as mind-body relaxation
technique) can be used for the promotion of people’s health and well-being. Here,
mind-body-based meditation practice is simple and safe for all classes of
people and we aim to assess its effect through self-reports, and EEG tools. Our target population is working people at their workplaces, faculty members, and
students. |