| CTRI Number |
CTRI/2024/08/071786 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [MINDFULNESS EXERCISE PROGRAM] |
| Study Design |
Other |
|
Public Title of Study
|
Mindfulness exercise program on professional quality of life |
|
Scientific Title of Study
|
Mindfulness exercise program on professional quality of life and coping strategies among nursing officers with burnout |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Velmurugan |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Medical Surgical Nursing, Nursing College, AIIMS, Bhopal.
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7982081965 |
| Fax |
|
| Email |
assistprof2.nursing@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. M. Abirami |
| Designation |
Vice Principal |
| Affiliation |
Bharath College of Nursing, Chennai |
| Address |
Dept. of Psychiatric Nursing,
Bharath College of Nursing,
Bharath Institute of Higher Education and Research,
Chennai -73
Chennai
TAMIL NADU
600073
India |
| Phone |
8870653119 |
| Fax |
|
| Email |
abisaisenthil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R. Velmurugan |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Medical Surgical Nursing, Nursing College, AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7982081965 |
| Fax |
|
| Email |
assistprof2.nursing@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| Nursing College, All India Institute of Medical Sciences,462020 M.P, India |
|
|
Primary Sponsor
|
| Name |
R Velmurugan |
| Address |
Assistant professor, Department of Medical Surgical Nursing, nursing college, AIIMS Bhopal |
| 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 |
| Mr R Velmurugan |
All India Institute of Medical Sciences, Bhopal |
Department of Medical Surgical Nursing, Nursing College, AIIMS Bhopal
Bhopal
MADHYA PRADESH |
7982081965
assistprof2.nursing@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| BHAARATH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| Institutional Human Ethics Committee- Student Research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z730||Burn-out, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness exercise program |
30 minutes lecture cum discussion on burnout and coping strategies after 10 minutes break practice session of mindful breathing, mindful concentration, mindful body scan, mindful releasing of tension, mindful walking and mindful eating for 30 minutes on 1st day. From 2nd day onwards 30 minutes of mindful exercises for next 13 days either formal or informal way daily. duration 14 days. |
| Comparator Agent |
routine care |
self-care for 14 days |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Nursing officers working in critical care areas with moderate to high risk of burnout.
2. Nursing officers who can read, understand, write and speak in english.
3. willingness to participate in study.
4. minimum 1 year experience in critical care areas. |
|
| ExclusionCriteria |
| Details |
1.Trainee nursing officers and student nurses working in critical care areas
2.Nursing officers who will be not available during study.
3.Nursing officers who practicing meditation, yoga, or any kind of relaxation
techniques regularly
4.Nursing officers who attended mindfulness courses either online or offline
5.Nursing officers with history of fracture or major musculoskeletal surgery at
the pelvis or lower limbs.
6.Nursing officers with any disabilities in their lower limb |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the effect of mindfulness exercise program on compassion fatigue, compassion satisfaction & coping strategies among nursing officers with burnout in study group. |
At baseline: Pre-test
After 2 weeks: Post-test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/09/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Burnout is characterized as a prolonged reaction to consistent emotional and relational stress in the workplace. Burnout is widespread among healthcare professionals (HCPs) in India, affecting nearly a quarter of them. Inadequate coping strategies also increase the likelihood of nurses experiencing depersonalization, which involves developing impersonal attitudes towards those under their care. Mindfulness is proposed as a possible approach to enhance nurses’ capacity to manage work-related stress effectively, leading to potential improvements in patient care. Workplace stress and burnout continue to be major issues in nursing. The nursing profession has long been associated with high levels of stress. Compassion fatigue and burnout pose significant risks to the well-being of nurses, potentially impairing their capacity to provide care for others in the long run. Nurses who reported higher levels of burnout tended to employ coping strategies such as escape/avoidance, self-controlling, and confronting. The mindfulness seems to serve as a safeguarding element against burnout.8 Over the past three decades, Mindfulness-based Interventions (MIs) have seen growing adoption among healthcare professionals to mitigate the risk of burnout. |