| 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
|
|
|
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
|
|
|
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. |