| CTRI Number |
CTRI/2023/04/052003 [Registered on: 26/04/2023] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the effect of Bhaktivedanta mantra audio therapy on critically ill patients in intensive care unit of tertiary care centre. |
|
Scientific Title of Study
|
A two arm, prospective, single centre, randomized, controlled, interventional study to assess effect of Bhaktivedanta mantra audio therapy on outcome of critically ill patients in intensive care unit of tertiary care centre. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Dalal |
| Designation |
Consultant Acupuncturist, Associate Professor-Spiritual Care |
| Affiliation |
Bhaktivedanta Hospital and Research Institute, Medical Research Department, |
| Address |
3rd Floor,Quality Assurance Office, Medical Research Department, Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane,401107, Maharashtra, India.
Thane
MAHARASHTRA
401107
India |
| Phone |
9324611434 |
| Fax |
|
| Email |
drkomal.d@bhaktivedantahospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Dalal |
| Designation |
Consultant Acupuncturist, Associate Professor-Spiritual Care |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
3rd Floor,Quality Assurance Office, Medical Research Department, Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane,401107, Maharashtra, India.
Thane
MAHARASHTRA
401107
India |
| Phone |
9324611434 |
| Fax |
|
| Email |
drkomal.d@bhaktivedantahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Dalal |
| Designation |
Consultant Acupuncturist, Associate Professor-Spiritual Care |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
3rd Floor,Quality Assurance Office, Medical Research Department, Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane,401107, Maharashtra, India.
Thane
MAHARASHTRA
401107
India |
| Phone |
9324611434 |
| Fax |
|
| Email |
drkomal.d@bhaktivedantahospital.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research Institute,Srishti Complex,Bhaktivedanta Swami Marg,Mira Road(East),Thane-401107 |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Srishti Complex,Bhaktivedanta Swami Marg, Mira Road(East),Thane-401107 |
| 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 Komal Dalal |
Bhaktivedanta Hospital and Research Institute |
1st Floor,OPD No. 6, General Medicine Dept,Srishti Complex,Bhaktivedanta Swami Marg, Mira Road(East),Thane-401107
Thane
MAHARASHTRA |
9324611434
drkomal.d@bhaktivedantahospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committe for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I469||Cardiac arrest, cause unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Spiritual Care Intervention |
Mantras to be heard as an intervention includes the following: •Aditya Hriday kavacha•Dhanvantari mantra•Hare Krishna mantra• Narasimha kavacha•Varaha kavacha
The above mentioned mantras will be made heard to the patients everyday for 10 hours till the time patient is admitted in the ICU |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.All Genders, Age >18 years
2.Reason for hospitalization; Primarily Sepsis, Congestive Heart Failure, Acute respiratory distress syndrome, cerebrovascular episodes with complications, CKD with concurrent complications, respiratory failures admitted to ICU, post operative patients, acute pancreatitis, polytrauma patients admitted to ICU.
3.Critically ill patients under the support of ventilator.
4.SOFA score > 6
5.If SOFA is less than 6 but if Acute Physiologic Assessment and Chronic Health Evaluation with GCS (Glasgow Coma Scale) < 8
|
|
| ExclusionCriteria |
| Details |
1.Patients with impaired hearing.
2.Age < 18
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To observe the impact of Bhaktivedanta mantra audio therapy in critically ill patients in number of ICU days and number of ventilator days.
2.To observe the changes in SOFA, GAD, FACIT, WHO-QOL score. |
The timepoint is of once in 3 days (i.e., baseline,3,6,9,12days …) till the time patient is admitted in the ICU. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the changes in blood sugar level and blood pressure level of the patients. |
The timepoint is of once in 3 days (i.e., baseline,3,6,9,12days …) till the time patient is admitted in the ward |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/05/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed to be a two arm, prospective, single center, randomized, controlled, interventional study. The Primary Objective of this study is to observe the effect of Bhaktivedanta mantra and music audio therapy on number of ICU days and Ventilator Days.
The Secondary Objective of this study is to observe the Change in SOFA score and Blood Pressure fluctuation in the patients. 1. The eligible patient will be assigned to either control or interventional group using simple randomization technique.
2. If the patient is assigned to a control group, they will receive only standard of care.
3. If the patient is assigned to an interventional group, they will receive standard of care along with it the patients will be made to hear recorded mantras which are prerecorded in a radio device for minimum of 12 hours.
4. The following Mantras will be heard as an intervention:
· Aditya Hriday kavacha
· Dhanvantari mantra
· Hare Krishna mantra
· Narasimha kavacha
· Varaha kavacha
5. The patient development will be assessed by the Sequential Organ Failure Assessment (SOFA) score in the timepoint of once in 3 days (i.e., 0,3,6,9,12days …) till the time patient is admitted in the ICU.
6. After the patients are shifted to the ward, the music therapy will continue for 12 hrs.
7. WHO-QOL, GAD and FACIT-spiritual questionnaire to be assessed in the following timepoints:
a. When the patient gets admitted in ICU.
b. When the patient shifts from ICU to ward.
c. When the patient gets discharged from the hospital.
8. After patient gets shifted or admitted to the ward following parameters as well as questionnaires will be evaluated:
a. GAD Score
b. WHO-Quality of Life
c. Blood Pressure
d. Blood Sugar Levels
The Endpoints of this study are:
1. To observe the impact of Bhaktivedanta mantra audio therapy in critically ill patients in number of ICU days and number of ventilator days.
2. To observe the changes in SOFA, GAD, FACIT, WHO-QOL score.
3. To observe the changes in blood sugar level and blood pressure level of the patients.
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