| CTRI Number |
CTRI/2018/04/013403 [Registered on: 20/04/2018] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
using Yoga as a technique for reducing stress in ICU Nursing Professionals |
|
Scientific Title of Study
|
Effect of Yoga on stress and psychological well-being in Intensive care Unit nurses: A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gautam Sharma |
| Designation |
Professor, Cardiology and Professor In-charge, Center of Integrative Medicine and Research (CIMR) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
CENTER OF INTEGRATIVE MEDICINE AND RESEARCH (CIMR)
CONVERGENCE BLOCK,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS)
NEW DELHI
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drsharmagautam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautam Sharma |
| Designation |
Professor, Cardiology and Professor In-charge, Center of Integrative Medicine and Research (CIMR) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
CENTER OF INTEGRATIVE MEDICINE AND RESEARCH (CIMR)
CONVERGENCE BLOCK,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS)
NEW DELHI
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drsharmagautam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsimarpreet Kaur |
| Designation |
Research Officer |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
CENTER OF INTEGRATIVE MEDICINE AND RESEARCH (CIMR)
CONVERGENCE BLOCK,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS)
NEW DELHI
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
harsimar89@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Centre of Integerative Medicine and Research (CIMR),
7th Floo, Room Number 7004
Convergence Block,
All India Institute of Medical Sciences
Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Centre for Integrative Medicine and Research
7th Floor, Room Number 7004
Convergence Block,
All India Institute of Medical Science (AIIMS),
New Delhi |
| 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 |
| Gautam Sharma |
All India Institute of Medical Sciences (AIIMS) |
Room Number 7004, 7th floor, CENTER OF INTEGRATIVE MEDICINE AND RESEARCH (CIMR)
CONVERGENCE BLOCK,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS)
NEW DELHI
South
DELHI |
01126549326
drsharmagautam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The subjects will be recruited from Intensive care unit and critical care unit of AIIMS based on the inclusion and exclusion criteria. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
The control group will not be subjected to any stress reliving technique. However, the control group will be trained in yoga for the same duration after the wait list period is over. |
| Intervention |
Yoga Group |
The intervention group will be taught yoga practices by institutionally trained yoga therapist (as per the protocol enclosed) at CIMR, AIIMS over a period of three months. During the study duration, the subjects will be invited to CIMR for the contact classes. There will be 45 contact classes in the study period. There will be one supervised sessions every alternate day. Each session will have a pre-planned curriculum that will progressively more challenging and which will facilitate adherence and secure repeatability of the intervention. Competitiveness will be discouraged. Participants will be encouraged to challenge themselves within their level of comfort and mentored to develop body awareness through the class instruction.
During the non-contact period the subjects will be encouraged to practice the yoga protocol at least 50 min/day. A log book will be given to all recruited participants to follow their practice at home including duration and time of practice. |
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Registered nursing officers and senior nursing officers working in Neurology ICU, Neurosurgery ICU, CTVS ICU and Main Hospital ICU and OTs will be recruited.
2. Willingness to participate.
3. Both gender
4. Age ranging from 25-50 years |
|
| ExclusionCriteria |
| Details |
1. Nursing staff posted in Cardiology ICU and CCU.
2. NOs and SNOs who were diagnosed with severe musculoskeletal, neurological or psychiatric illness.
3. Those who receiving treatment for hormonal imbalance.
4. Subjects with recent surgical intervention and regularly practicing yoga will be excluded. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Perceived stress scale
2. Brook’s Quality of Nursing Work Life Survey |
Pre and Post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General Self-Efficacy Scale (GSE) |
Pre and Post |
| Burnout inventory |
Pre and Post |
| Biological stress marker - “Cortisol†|
Pre and Post |
| Metabolic profile including Anthropological measurements (Weight, BMI, Hip and Waist ratio, mid arm circumference, skin-fold thickness), fasting and postprandial blood sugar, HbA1C, Lipid Profile, Thyroid Profile, Liver Function Test, Kidney Function Test, Mean Blood Pressure. |
Pre and Post |
| Knowledge, Attitude and Practice toward Yoga Questionnaire. |
Pre and Post |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2018 |
| 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) |
Other (Terminated) |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Nursing eternity is the most valuable assets of any hospital, whose individual performance affects the performance of the entire Hospital. One of the factors affecting performance in Hospitals is work place stress, which puts the Physical as well as psychological health of many Nursing Officers (NO) at risk. Psychological wellbeing underscores the close assembly between wellbeing at psychological aspects of our experience (e.g., our thoughts, emotions, and behavior) and our wider social experience (e.g., our relationships, traditions and culture). It is the combination of feeling good and functioning effectively. There are many psychological variables; mindfulness, self-compassion, empathy, resilience, and Interpersonal relationship which are easily influenced by stress and reduce the productivity. Yoga is rooted in Indian philosophy and now has been found as a route to physical and mental wellbeing as a stress management intervention.Several studies have already demonstrated the stress reducing effects of yoga and meditation practices in nurses. The working condition of the Intensive Care Unit (ICU) nurses as compared to their counterparts is stressful thereby affecting their psychological wellbeing. As per the existing evidence available, this study will be one of the first studies trying to explore the effect of Yoga on stress and psychological wellbeing of ICU nurses working in a highly demanding working tertiary care center in India. Objectives: Primary objective - 1. To evaluate the effect of yoga practices on the perceived stress levels and Quality of Life of the nurses posted in Intensive Care Units.
Secondary objectives - 1. To evaluate the effect of yoga on burnout symptoms and self-efficacy of ICU, and CCU nurses using a burnout inventory and General Self-Efficacy Scale (GSE).
- 2. To evaluate the effect of yoga on general metabolic parameters of ICU, and CCU nurses including Anthropological measurements (Weight, BMI, Hip and Waist ratio, mid arm circumference, skin-fold thickness), fasting and postprandial blood sugar, HbA1C, Lipid Profile, Thyroid Profile, Liver Function Test, Kidney Function Test, Mean Blood Pressure and serum cortisol.
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