| CTRI Number |
CTRI/2025/07/090484 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Physical and Mental Well-Being in Physiotherapy Professionals |
|
Scientific Title of Study
|
Effect of a “Mind-Body Mixed Method Approach” on Physical and Mental Well-Being of
Physiotherapy Professionals: A Quasi-Experimental Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pawan Singh Khatana |
| Designation |
Ph.D Scholar |
| Affiliation |
galgotias university |
| Address |
Room no B-512 School of allied health sciences department of physiotherapy Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717337363 |
| Fax |
|
| Email |
khatana101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDr Shagun Agarwal |
| Designation |
Dean |
| Affiliation |
galgotias university |
| Address |
Room no B-512 School of allied health sciences department of physiotherapy Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9910259583 |
| Fax |
|
| Email |
dean.sahs@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Pawan Singh Khatana |
| Designation |
Ph.D Scholar |
| Affiliation |
galgotias university |
| Address |
Room no B-512 School of allied health sciences department of physiotherapy Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717337363 |
| Fax |
|
| Email |
khatana101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell Galgotias University Plot No. 2, Yamuna Expy, opposite
Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
B Block Room ,no-B-512 Department of Physiotherapy Plot
No.2,Galgotias university, Yamuna expy, opposite Buddha
international circuit, Sector 17A,Greaternoida Uttar Pradesh India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Pawan Singh Khatana |
Galgotias Hospital, School Of Allied Health Sciences Galgotias University |
Physiotherapy OPD E003-blockE , School of allied health sciences department of physiotherapy Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
09717337363
khatana101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Working Physiotherapist Professionals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mind-Body Mixed Method Approach |
MBMM Approach including
MIND-body Mix Methods of
1.Jacobson Progessive Muscle Relaxation (5-Min.)
2.Deep breathing Exercises ( diaphragmatic Breathing) (5Min.)
3.Mental imagery (5Min.)
(15 min Intervention for 4 weeks) |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All the qualified Physiotherapist working in health care sector. |
|
| ExclusionCriteria |
| Details |
All the qualified Physiotherapist but not working in health care sector |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perceived stress, General Well Being, BP , Heart Rate |
0- day and at completion of 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="0"
Months="1"
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 - 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 - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - data will be provided on e mail
- For how long will this data be available start date provided 02-09-2025 and end date provided 02-01-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Freudenberger (1974) and Maslach (1976) were the first to describe Burnout Syndrome (BOS). It is defined
as a state of mental exhaustion and depression at work accompanied by fatigue and decreased ability to
cope with cognitive and emotional needs and mental distancing. Healthcare professionals are most
commonly affected by BOS as they spend more hours dealing with the pain and problems of patients.
Physiotherapy is a profession that needs long-term interaction with the patients as they also have to deal
with patients’ psychological issues like depression and aggression. Thus, physiotherapists as health care
providers are markedly exposed to strain because of close interaction with sick people who require medical
attention for a longer duration. Many studies have proved the vulnerability of physiotherapists to Burnout
Syndrome. But there is less focus on the prevention and management protocols.
Prevalence figures for Maslach Burnout Inventory dimensions were:
(i) Emotional exhaustion, 27%
(ii) Depersonalization, 23%
(iii) Low personal accomplishment, 25% .
Prevalence was higher in developing than in developed countries.
Conclusion of Prevalence of burnout reported by physiotherapists appears high worldwide, in particular in
developing countries, and compares with that reported by nurses and physicians. Substantial heterogeneity
in the prevalence of burnout |