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CTRI Number  CTRI/2024/12/078307 [Registered on: 18/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral
Other (Specify) [Meditation Spiritual Care]  
Study Design  Single Arm Study 
Public Title of Study   Study on effect of Spiritual Care and Counselling on Stress, Anxiety, Stress, Depression and Sleep parameters in ICU Nurses 
Scientific Title of Study   A prospective, interventional, single-center study to assess the impact of spiritual care practices and counseling on changes in stress levels, anxiety levels along with sleep quality, and cognitive functions among ICU, IMCU, CCU nurses.  
Trial Acronym  NIL 
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 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Room No.2, 3rd Floor, 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 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Room No.2, 3rd Floor, 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 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Room No.2, 3rd Floor, 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, Mira Road, Thane, Maharashtra, India 401107 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute 
Address  Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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   ICU, IMCU, CCU Wards, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nurses working in ICU, IMCU, CCU 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mindful Meditation Practice and Counselling Session  The intervention includes mindfulness meditation practice, where nurses will chant the Hare Krishna Maha mantra for 15 minutes, five times a week before their shift, complemented by monthly 15-minute counseling sessions led by a certified psychologist. These sessions incorporate techniques such as box breathing to enhance focus and relaxation, mindfulness meditation for grounding and gratitude, Neuro-Linguistic Programming (NLP) stress reduction techniques using posture, breathing, and inner dialogue adjustments, and positive self-talk affirmations to foster resilience and self-belief.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1. All Genders, Above 18 years.
2. Nurses working in ICU, IMCU, CCU.
3. Nurses who are willing to consent for the study.
 
 
ExclusionCriteria 
Details  Exclusion criteria:
1. Nurses who are not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the effectiveness of spiritual care practices and counseling in changing the stress and anxiety scores among ICU nurses.
2. To assess the impact of spiritual care practices on improving sleep quality in ICU nurses.
3. To assess the changes in cognitive functions of the ICU nurses
 
Outcomes will be assessed at the 3rd and 6th months from the date of enrolment. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="59"
Sample Size from India="59" 
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)   01/01/2025 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Healthcare professionals, particularly nurses, experience significant stress due to routine demands and critical incidents, which can exceed their usual coping mechanisms. Recent studies have indicated that their stress levels have increased, particularly after the COVID-19 pandemic, impacting both their mental as well as physical well-being and patient safety. Prolonged stress can lead to physical and psychological health problems, including high blood pressure, fatigue, and sleep disorders, and is influenced by a combination of individual factors, personal circumstances, and work environment.

The primary objectives of this study are to evaluate the effectiveness of spiritual care practices and counseling in reducing stress and anxiety levels among ICU nurses, assess the impact of these practices on sleep quality, and examine any changes in cognitive functions. The study will include 59 nurses from ICU, IMCU, and CCU settings who are over 18 years old and willing to provide consent. 

Monthly counseling sessions (15 minutes per member) will be conducted by a certified psychologist, incorporating techniques such as box breathing, mindfulness meditation, Neuro-Linguistic Programming (NLP) stress reduction, and positive self-talk. 

Nurses will be evaluated using standardized questionnaires such as the DASS-21 scale for stress, anxiety, and depression, the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, and a Cognitive Assessment Questionnaire. Questionnaires will assess at baseline (Day 0), at  3rd month (pre-intervention), and at 6th month (post-intervention). To ensure participants adherence to study interventions, participants will maintain a diary, which will be reviewed monthly by the study team. The study duration is of one year.

 
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