| CTRI Number |
CTRI/2022/11/047307 [Registered on: 15/11/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Guided meditation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of guided meditation in critically ill patients |
|
Scientific Title of Study
|
Physiological and Psychological effects of guided meditation in critically ill patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhalendu Vaishnav |
| Designation |
Professor and Head, Department of Medicine |
| Affiliation |
Pramukhswami Medical College |
| Address |
Intensive care unit,
Department of Medicine
Pramukhswami Medical College, Bhaikaka University, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9825717481 |
| Fax |
|
| Email |
bhalendusv@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhalendu Vaishnav |
| Designation |
Professor and Head, Department of Medicine |
| Affiliation |
Pramukhswami Medical College |
| Address |
Intensive care unit,
Department of Medicine
Pramukhswami Medical College, Bhaikaka University, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9825717481 |
| Fax |
|
| Email |
bhalendusv@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhalendu Vaishnav |
| Designation |
Professor and Head, Department of Medicine |
| Affiliation |
Pramukhswami Medical College |
| Address |
Intensive care unit,
Department of Medicine
Pramukhswami Medical College, Bhaikaka University, Karamsad.
Anand
GUJARAT
388325
India |
| Phone |
9825717481 |
| Fax |
|
| Email |
bhalendusv@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| Institution, Principal Investigator.
Dr Bhalendu Vaishnav.
Intensive care unit,
Department of Medicine
Pramukhswami Medical College, Bhaikaka University, Karamsad 388325 |
|
|
Primary Sponsor
|
| Name |
Dr Bhalendu Vaishnav |
| Address |
Professor and Head, Department of Medicine
Pramukhswami Medical College, Karamsad |
| 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 Bhalendu Vaishnav |
Shree Krishna Hospital |
Intensive care unit, Shree Krishna Hospital, Pramukhswami Medical College, KaramsadKaramsad
Anand
GUJARAT |
9825717481
bhalendusv@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, (2) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guided meditation |
Structured guided meditation practice will be offered to the participants through an audio device for duration of 20 minutes daily for at least 3 days. |
| Comparator Agent |
Standard Care |
Control arm will receive treatment as per standard of care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subset 1__ Physiological and Psychological effects of guided meditation in critically ill obstetric patients_Inclusion Criteria_Critically ill conscious obstetric patients (antenatal/postnatal) who are not on mechanical ventilation.
Subset 2_Physiological and Psychological effects of guided meditation in critically ill traumatic brain injury patients who are on mechanical ventilation.Inclusion Criteria_Critically ill traumatic brain injury patients (on medical management/ post operative patients) who are on mechanical ventilation
|
|
| ExclusionCriteria |
| Details |
Subset 1_Exclusion Criteria
1. Hemodynamically unstable patients.
2. Patients having any psychiatric disease
3. Patients whose condition gets changed to other category due to course of illness (e.g. those who worsen and require ventilation, etc)
4. Patients with altered mental status.
5. Patients having cardiac arrythmias.
6. Patients would be excluded from the experiment in the event of death, transferring to other medical centers or discharge, the need for emergency surgery during the study.
Subset_2:1. Hemodynamically unstable patients.
2. Patients on N-M blockage drugs
3. Patients having any psychiatric disease
4. Likely survival of less than 3 days
5. Patients whose condition gets changed to other category due to course of illness (e.g. those who improved and extubated, etc)
6. Patients would be excluded from the experiment in the event of death, transferring to other medical centers or discharge, the need for emergency surgery during the study.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subset 1 & 2:Effect of guided meditation on heart rate variability |
Before and after each guided meditation session on all 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subset_1_Effect of guided meditation on anxiety and wellbeing as measured by visual analogue scale, Effect of guided meditation on physiological parameters, viz. Heart rate, Blood pressure, SpO2, Respiratory rate
Subset_2_Effect of guided meditation on sedative requirement,effect of guided meditation on opioid requirement,Effect of guided meditation on physiological parameters, viz., Heart rate, Blood pressure, SpO2, Respiratory rate.
|
Before and after each guided meditation session on all 3 days |
|
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
17/11/2022 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Results will be published apprpriately |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhalendusv@charutarhealth.org].
- For how long will this data be available start date provided 30-06-2024 and end date provided 31-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Critically ill patients undergo a significant amount of environmental and psycho-physical stress. Indeed, not only is their severe and debilitating underlying clinical condition stressful, but they also are subject to a wide array of stressors, related to the environment in which they are cared and to the procedures to which they undergo, which all have been associated with significant discomfort. Anxiety is a common finding in hospitalized patients, and even more in those who are critically ill. It was suggested that up to 80% of patients in the ICU may suffer from anxiety, especially in those undergoing mechanical ventilation.
The categories of long-term effects of sepsis include immune-metabolic, neurocognitive, psychiatric, and physical derangements. These effects lead to increased mortality and severely worsened health-related quality of life. Health care professionals and family members pay a heavy cost—in both money and energy—in caring for these patients with sizable health issues. The current goals of care for patients who survive sepsis include approaches that are effective in early sepsis, controlling pain, agitation, and delirium, and early mobilization. However, there is an unmet need of developing efficient therapeutic strategies specifically tailored towards sepsis survivors. While the administration of drugs plays an undoubtful role in the management of ICU-related stress, there are a variety of non-pharmacologic interventions and protocols, that have shown to be able to effectively prevent and treat various manifestations of ICU stay. Various relaxation interventions have been shown to reduce stress, anxiety and pain level, bring about parasympathetic shift in heart rate variability and promoting relaxation in different cohorts of healthy individuals and those suffering from various diseases. However, there is dearth of studies in this area.
Present study aims to analyze physiological and psychological effects of guided meditation on critically ill patients::Subset 1: Conscious, critically ill obstetric patients, Subset 2: Unconscious patients of Traumatic brain Injury
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