| CTRI Number |
CTRI/2022/07/044164 [Registered on: 20/07/2022] Trial Registered Prospectively |
| Last Modified On: |
22/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mind Sound Resonance Technique for musculoskeltal pain at old age homes |
|
Scientific Title of Study
|
Mind Sound Resonance Technique on Musculoskeltal pain, Sleep Quality, Stress and State Anxiety on Geriatric patients at old age homes: A RANDOMIZED CONTROL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr H M Vinaya |
| Designation |
MD Scholar |
| Affiliation |
Swami VivekanandaYoga Anusandhana Samsthana SVYASA Deemed to be university |
| Address |
Swami VivekanandaYoga Anusandhana Samsthana SVYASA
Deemed to be university
Department of PG studies
division of yoga and life sciences(no room number applicable)
Kalluballu post
Anekal Jigani
Bangalore
KARNATAKA
560105
India |
| Phone |
7411397589 |
| Fax |
|
| Email |
vinayamuralidhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrApar Avinash Saoji |
| Designation |
Principal |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana, Bangalore |
| Address |
The School of Yoga and Naturopathic Medicine, Swami Vivekananda
Yoga Anusandhana Samsthana (S-VYASA) Deemed to be
University Kalluballu post Anekal Jigani
Bangalore
KARNATAKA
560105
India |
| Phone |
7972895122 |
| Fax |
|
| Email |
aparsaoji@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr H M Vinaya |
| Designation |
MD Scholar |
| Affiliation |
Swami VivekanandaYoga Anusandhana Samsthana SVYASA Deemed to be university |
| Address |
Swami VivekanandaYoga Anusandhana Samsthana SVYASA
Deemed to be university Kalluballu post Anekal Jigani
Bangalore Rural
Bangalore
KARNATAKA
560105
India |
| Phone |
7411397589 |
| Fax |
|
| Email |
vinayamuralidhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SVYASA University Kalluballu post Anekal Jigani Bangalore Rural Karnataka 560105 India |
|
|
Primary Sponsor
|
| Name |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Kalaballu Post, Jigani, Bengaluru 560105 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 HM Vinaya |
SVYASA University |
Swami Vivekananda
Yoga Anusandhana
Samsthana,
Department of whole
PG studies, division of
yoga and life sciences,
(no room number
applicable) Kalluballu
post, Anekal, Jigani
560105
Bangalore Rural
KARNATAKA |
7411397589
vinayamuralidhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lifestyle suggestions |
Participants would be offered
with lifestyle suggestions for
their subjective pain symptom
reduction
After 2 months
intervention period they would
be invited for yoga practices
|
| Intervention |
Mind sound resonance technique |
Mind sound resonance technique is a relaxation technique comprising mahamrutyunjaya mantra along with aa au mm and om sylabell chantings both loudly and mentally slowly for three rounds each this technique is given for 30 minutes everyday for a period of 8 weeeks |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
older adults who are staying at old age homes for more than two months above sixty years of age with no prior exposure to yoga and are willing to participate in the study
recent covid history and patients suffering from chronic illness like hypertension diabetes asthma migraine are also included in the study |
|
| ExclusionCriteria |
| Details |
Patients who has undergone recent surgery
Patients with Alzheimer’s, mental retardation.
Recent fall history are excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| musculoskeletal pain |
musculoskeletal pain is assesed at baseline and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
sleep quality
stress
state anxiety |
sleep quality
stress
state anxiety assesed at baseline and at 8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2022 |
| Date of Study Completion (India) |
31/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/01/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Primary purpose of the study is to reduce musculoskeletal pain which is very common problem faced by older adults and to increase their sleep quality by decreasing stress and anxiety by following regular 30 minutes of mind sound resonance technique everyday for 2 months. We will be doing face-face health interview survey for screening and enrolment of participants with subjective pain symptom, and a representative sample of 70 would be selected. Questionnaires such as Musculoskeletal health questionnaire (MSHQ), Perceived Stress Scale (PSS-10), Pittsburgh Sleep Quality Index (PSQI) geriatric anxiety scle (GAS) will be used for the assessment. Mind sound resonance technique will be used as the intervention, aiming on their physical and mental pain, stress perceived ,anxiety and to improve sleep quality of participants. |