| CTRI Number |
CTRI/2024/10/074695 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Immediate effect of DRT(Deep Relaxation Technique) |
|
Scientific Title of Study
|
Immediate effect of Deep Relaxation Technique (DRT) on Heart Rate
Variability among Healthy individuals – A Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Harishma |
| Designation |
PG Scholar |
| Affiliation |
nternational Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (First Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9751143555 |
| Fax |
|
| Email |
harishmakrishnan16@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr A GayathrI |
| Designation |
Head Of Department I/C (Yoga) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (First Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
Kancheepuram TAMIL NADU 603001 India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr A GayathrI |
| Designation |
Head Of Department I/C (Yoga) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (First Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
TAMIL NADU 603001 India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical College hospital, Chengalpattu, Tamilnadu -603001 |
|
|
Primary Sponsor
|
| Name |
Dr S Harishma |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SHarishma |
International Institute of Yoga and Naturopathy Medical hospital |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (First Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU Kancheepuram TAMIL NADU |
09751143555
harishmakrishnan16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
rest in sitting position |
No intervention for comparative group.Patients have to rest sitting for
duration 20 minutes |
| Intervention |
Deep Relaxation Technique |
Patients have to perform Deep
Relaxation Technique (DRT) for
duration of 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patient should be underage of 18- 35 years. Both male and female healthy participants who are willing to give their consent |
|
| ExclusionCriteria |
| Details |
Participants with spinal injuries, psychiatric illness, systemic illness, surgical history, Congenital comorbidities, Pregnancy and mensuration.
Regular Yoga practicing induvial are exclude from this study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
HRV is the beat-to-beat variation of the cardiac cycle that represents sympathovagal
balance. The lead II ECG will be recorded using the Analogue ECG amplifier with A to
D (Analogue to Digital) conversion using the sound card inside the computer. The data
was analyzed using KUBIOS 1.1 software, Finland, which is used to measure the
different variables such as the time or frequency domain. Time-domain analysis is
calculated directly from the raw RR interval. The frequency domain shows the variability
of the RR signal over time by looking at the proportion of the wavelengths relative to the
original RR- signal. |
Immediately before and after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diastolic & systolic blood pressures |
Immediately before & after the practice of DRT |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/10/2025 |
| 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="1" Months="1" Days="1" |
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 12-08-2025 and end date provided 16-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nothing
|
|
Brief Summary
|
Deep Relaxation Technique (DRT) which is a form of Yogic
Relaxation Technique developed at Swami Vivekananda Yoga Anusadhana Samsthan,
Bengaluru was given for 20 minutes as an intervention. It is a systematic
method of developing inner awareness. It emphasizes part-by-part
relaxation of the whole body. It works at all levels of the existence of an
individual at physical, mental, emotional, intellectual, and spiritual levels. It
involves the relaxation of all body parts by directing the attention of the
mind on different parts of the body starting from the toes to end up in the
head region to propagate the relaxation feeling. DRT is known to reduce the
state of anxiety and to improve sustained attention, also helps to improve sleep
quality. The practice of relaxation techniques has been shown to modify
the autonomic response to mental stress which is generally termed as
relaxation response, that tends to restore the altered sympatho-vagal balance
towards normal. Probable 3 physiological mechanisms in meditation would be
sensory attenuation, motor attenuation, and nonanalytical thinking, evoking
minimal cortical activity. Heart rate variability (HRV) measures the
beat-to-beat changes in heart rate and provides information on how the
parasympathetic and sympathetic nervous systems control the cardiovascular
system. Through the sinoatrial (SA) node, increased sympathetic nervous system
activity raises heart rate, whereas increased parasympathetic nervous system
(vagus nerve) activity lowers heart rate. Though the multifaceted physiological
and psychological health benefits of both short- and long-term yoga training
are quite well established, only very few studies have reported on the
immediate effects of a single session. |