| CTRI Number |
CTRI/2024/10/074705 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing how well guided meditation and sound-based relaxation help people sleep better. |
|
Scientific Title of Study
|
The Effect of Yoga Nidra and Nadanusandana to improve Sleep Quality – A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rithik Narayanan |
| Designation |
Junior Resident Student |
| Affiliation |
Rajiv Gandhi University of Health and Sciences |
| Address |
SDM college of Naturopathy and Yogic Sciences, First floor,
Department of Naturopathy and yoga, room number 2, Ujire,
Belthangady, Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8891525196 |
| Fax |
|
| Email |
ritz.009977@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rithik Narayanan |
| Designation |
Junior Resident Student |
| Affiliation |
Rajiv Gandhi University of Health and Sciences |
| Address |
SDM college of Naturopathy and Yogic Sciences, First floor,
Department of Naturopathy and yoga, room number 2, Ujire,
Belthangady, Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8891525196 |
| Fax |
|
| Email |
ritz.009977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yohi |
| Designation |
Medical Officer |
| Affiliation |
SDM college of Naturopathy and Yogic Sciences, Ujire, Belthangady |
| Address |
SDM college of Naturopathy and Yogic Sciences, First floor,
Department of Naturopathy and yoga, room number 2, Ujire,
Belthangady, Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9842696017 |
| Fax |
|
| Email |
thyohi19@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Yoga and nature cure hospital Shanthivana, Dharmasthala, Belthangady, Karnataka, India.
Pincode- 574240 |
|
|
Primary Sponsor
|
| Name |
Rithik Narayanan |
| Address |
SDM college of Naturopathy and Yogic Sciences, Ujire, Belthangady,
karnataka, India pincode-574240 |
| Type of Sponsor |
Other [Self] |
|
|
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 Yohi |
SDM Yoga and Nature Cure Hospital |
Tejas Yoga Hall,Hall No 1, Ground floor,
Yoga Department, SDM yoga
and Nature Cure
hospital, Shanthivana,
Dharmasthala.
pincode-574216
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9842696017
thyohi19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara Naturopathy And Yoga Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nadanusandana |
1. Sit in any meditative position and adopt Chin Mudra.
2. Take a couple of breaths to centre yourself and draw the attention inwards.
3. A-kara chanting.
3.1 Slowly inhale to fill the lungs completely, and begin to chant A-kara in a low voice (just the ‘AAA’ sound).
3.2 Notice how the sound reverberates in the abdomen.
3.3 Repeat 9 times.
4. U-kara chanting
4. 1 With Chinmaya Mudra, Slowly inhale to fill the lungs and completely, and begin to chant ‘UUU’ in a low pitch.
4.2 Notice how the sound reverberates in the chest and middle part of the body.
4.3 Repeat 9 times.
5. M-kara chanting
5.1 With Aadi Mudra, Slowly inhale to fill the lungs and completely, and begin to chant ‘MMM’ in a low pitch.
5.2 Notice how the sound resonates in the throat and head region.
5.3 Repeat 9 times.
6. AUM chanting
6.1 Inhale slowly and completely fill the lungs.
6.2 Adopt Brahma mudra (thumb inside the fist) and exhale to chant AUM in a low voice.
6.3 Feel the sound resonate throughout the body.
6.4 Repeat nine times.
7. To close the practice, take another few deep breaths becoming aware of any sensations in the body and observe your emotional state. |
| Intervention |
Yoga Nidra |
A pre-recorded yoga nidra audio session will be used. Yoga nidra will be practiced for 20 minutes. There are 8 stages of Yoga Nidra. I. Relaxation- Primary preparation of the body. II. Affirmation (Sankalpa)- A personal goal previously decided upon is declared silently. III. Rotation of Consciousness IV. Respiration awareness - A period of awareness of the breath V. Manifestations of opposites - experience Pairs of feelings and emotions VI. Creative visualization- various types of images are mentally visualized. VII. Affirmation - repeat again VIII. Return to full awareness- gradually return to the normal state. Individuals who became too agitated to focus on the exercise were asked to end the session. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give consent |
|
| ExclusionCriteria |
| Details |
1. Neuropsychological issues
2. Systemic illness
3. Auditory impairment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep Quality Scale (SQS) |
base line before starting intervention and after 10
days of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pittsburg Sleep Quality Index (PSQI) |
base line before starting intervention and after 10
days of intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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="1"
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 - NO
|
|
Brief Summary
|
THE EFFECT OF YOGA NIDRA AND NADANUSANDANA TO IMPROVE SLEEP QUALITY – A COMPARATIVE STUDY
Purpose: Complementary and alternative medicine is shown to improve both health and sickness. As a result, the idea of therapeutic yoga has evolved and it is essential to develop standardized models. According to studies, yoga may be conducted in a variety of ways. Even though therapeutic yoga i.e. Yoga Nidra and Nadanusandana is used extensively in the treatment of various diseases, its comparative study on sleep quality is not studied yet. Hence the present study is designed to compare and evaluate the effect of yoga nidra and nadanusandana to improve the sleep quality.
Method: Group 1 (n=20): Yoga nidra(20 minutes) for 10 days Group 2 (n=20): Nadanusandana (20 minutes) for 10 days
Outcome variable:
Primary outcome: Sleep Quality Scale(SQS)
secondary outcome: Pittsburg Sleep Quality Index (PSQI)
Data will be collected at the baseline before starting the intervention and after the 10 days of intervention |