To check the effect of Bhaktivedanta mantra audio therapy on critically ill patients in intensive care unit of tertiary care centre.
- Conditions
- Cardiac arrest, cause unspecified,
- Registration Number
- CTRI/2023/04/052003
- Lead Sponsor
- Bhaktivedanta Hospital and Research Institute
- 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 carealong 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
- 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.
1.Patients with impaired hearing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To observe the impact of Bhaktivedanta mantra audio therapy in critically ill patients in number of ICU days and number of ventilator days. The timepoint is of once in 3 days (i.e., baseline,3,6,9,12days …) till the time patient is admitted in the ICU. 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
Bhaktivedanta Hospital and Research Institute
🇮🇳Thane, MAHARASHTRA, India
Bhaktivedanta Hospital and Research Institute🇮🇳Thane, MAHARASHTRA, IndiaDr Komal DalalPrincipal investigator9324611434drkomal.d@bhaktivedantahospital.com