| CTRI Number |
CTRI/2023/04/051780 [Registered on: 19/04/2023] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of yoga based relaxation on emotions and Quality of life in patients with Post traumatic stress disorder (PTSD) |
|
Scientific Title of Study
|
Effect of MSRT On Emotional Regulation and Sleep Quality in those experiencing PTSD symptoms - A Randomised 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 |
Shivakameshwari D |
| Designation |
BNYS Intern |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
The School of Yoga and Naturopathic Medicine, S-VYASA Deemed to be University,
Prashanti Kuteeram,
Vivekananda Road, Manhcanahalli, Kalaballu Post, Jigani, Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
|
| Fax |
|
| Email |
dattathrishivakami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arundhati Goley |
| Designation |
Asst Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
The School of Yoga and Naturopathic Medicine, S-VYASA Deemed to be University,
Prashanti Kuteeram,
Vivekananda Road, Manhcanahalli, Kalaballu Post, Jigani, Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
|
| Fax |
|
| Email |
drarundhatigoley@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arundhati Goley |
| Designation |
Asst Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
The School of Yoga and Naturopathic Medicine, S-VYASA Deemed to be University,
Prashanti Kuteeram,
Vivekananda Road, Manhcanahalli, Kalaballu Post, Jigani, Bengaluru
KARNATAKA
560105
India |
| Phone |
|
| Fax |
|
| Email |
drarundhatigoley@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| Swami Vivekananda Yoga Anusandhana Samsthana |
|
|
Primary Sponsor
|
| Name |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Prashanti Kuteeram,
Vivekananda Road, Manhcanahalli, Kalaballu Post, Jigani, Bengaluru |
| 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 |
| Shivakameshwari D |
Swami Vivekananda Yoga Anusandana Samsthana |
S-VYASA Deemed to be University,
Prashanti Kuteeram,
Vivekananda Road, Manhcanahalli, Kalaballu Post, Jigani, Bengaluru
Bangalore
KARNATAKA |
9789501660
dattathrishivakami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swami Vivekananda Yoga Anusandhana Samsthana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F431||Post-traumatic stress disorder (PTSD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guided Relaxation |
Guided relaxation includes scanning the entire body to improve awareness and relaxation. It will be given to the control group 4 times a week for a duration of 8 weeks. |
| Intervention |
Mind Sound Resonance Technique (MSRT) |
MSRT is an advanced Yogic relaxation technique that consists of Mind, Sound and Resonance created by repeating a mental sound. It will be given 4 times a week for a duration of 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Time duration between post-traumatic stress and intervention varies from 2 to 4 months
2. Those individuals who marked moderately, quite a bit or extremely for the following questions in the Posttraumatic Stress Disorder Checklist for DSM- 5 (PCL- 5) and with cutoff score above 38:
a) One or more symptoms from questions 1 to 5
b) One or more symptoms from questions from either 6 or 7
c)Two or more symptoms from questions from 8 to 14
d)Two or more symptoms from question 15 to 20.
3. Should not be under antipsychotic medications. |
|
| ExclusionCriteria |
| Details |
1. Individuals with any major health problems such as cardiac, pulmonary, metabolic, disorders
2. Individuals who have prior exposure to yoga.
3. Women undergoing pregnancy or lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difficulties in Emotional Regulation Scale (DERS) |
Baseline (day 0) and 8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh Sleep Quality Inventory |
Baseline (day 0) and 8 Weeks |
| Satisfaction with Life (SWL) scale |
Baseline (day 0) and 8 Weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2023 |
| Date of Study Completion (India) |
11/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
“Post-traumatic stress disorder (PTSD) is a psychiatric disorder that may occur in people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An individual may experience this as emotionally or physically harmful or life-threatening and it may affect their mental, physical, social, and/or spiritual well-being†(Taylor-Desir, 2022). Sexual and physical assault/abuse, divorce, death of loved one, domestic violence, separation, neglect are some traumas faced by women. .Individuals undergo persistent and unwanted reminders of traumatic events, avoidance of people, places and activities that serve as a memory to the event or change in emotional state. Mind Sound Resonance Technique (MSRT), a technique which consists of 3 components – Mind, Sound and Resonance. It is a combination of mantra chanting and mindfulness that helps improve both physical and psychological health. MSRT will help in improving emotional regulation and sleep quality. This trial is set to check the effectiveness of MSRT on women with PTSD and their symptoms. |