| CTRI Number |
CTRI/2024/05/068086 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To find effect of belly breathing and Jacobsons relaxation technique in female school teachers with chronic workplace stress |
|
Scientific Title of Study
|
Effect of Diaphragmatic breathing and Jacobsons relaxation technique in female school teachers with burnout syndrome |
| 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 Sushama Bhandare |
| Designation |
Assistant Professor |
| Affiliation |
Seth GSMC and KEMH |
| Address |
PT school and centre, Seth GSMC and KEMH
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820219984 |
| Fax |
|
| Email |
sushamab7@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishakha Mulaokar |
| Designation |
PG Student |
| Affiliation |
Seth GSMC and KEMH |
| Address |
PT school and centre, Seth GSMC and KEMH
Acharya Donde Marg
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09370253842 |
| Fax |
|
| Email |
vishakha.mulaokar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishakha Mulaokar |
| Designation |
PG student |
| Affiliation |
Seth GSMC and KEMH |
| Address |
PT school and centre, Seth GSMC and KEMH
Acharya Donde Marg
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09370253842 |
| Fax |
|
| Email |
vishakha.mulaokar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy school and centre, seth G S Medical college and KEM Hospital, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Physiotherapy School and centre Seth G S Medical college Mumbai |
| Address |
PHYSIOTHERAPY SCHOOL AND CENTRE ,SETH GS MEDICAL COLLEGE, PAREL MUMBAI |
| Type of Sponsor |
Government medical college |
|
|
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 Vishakha Mulaokar PT |
Physiotherapy School and centre, Seth GSMC |
OPD 402, Physiotherapy school and centre, Seth G S Medical college and KEM Hospital, Mumbai
Mumbai
MAHARASHTRA |
09370253842
vishakha.mulaokar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE -2 OF SETH GS MEDICAL COLLEGE MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
33 Female School Teachers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diaphragmatic breathing |
Duration: 15 minutes
Frequency: 3 times a week for 4 weeks |
| Intervention |
Jacobsons relaxation technique |
Duration: 12 minutes
Frequency: 3 times a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Female school teachers
2.Those who are Willing to participate,this consent will be taken on informed consent document
3.Those who are between 30 to 55 years of age.
4.After their consent, participants will be grade on work related version of Burnout Assessment Tool. Those who fall in high and very high grading of work related version of Burnout Assessment Tool , those teachers will be included.
5.Have worked for at least 1 year |
|
| ExclusionCriteria |
| Details |
1. Those who have undergone any psychiatric session or was on psychiatry medications 2. Those who are doing any meditation course or undergoing any counseling sessions, because if they are undergoing any meditation course or counseling sessions and their Burnout reduces after that, then it will be difficult to justify with which treatment their Burnout reduces. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Work related version of Burnout Assessment Tool (BAT 23 ) |
Pre intervention - 0 week
Post intervention - after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
10/06/2024 |
| 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 Yet Recruiting |
| 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
|
The World Health Organization’s International Classification of Diseases (ICD- 11; 2019) defines burnout as: A syndrome conceptualized as resulting from chronic workplace stress that has not been successfully managed.Burnout is a self explanatory term in itself which says that the person is burned out, which means he is no longer able to burn or use his energy for fulfilling demands. Today’s lifestyle incorporates lot of multitasking. Meeting daily needs and maintaining adequate performance at the level of family, friends, social life and work is difficult to manage. With time, individual might have to face stress levels which are bound to follow because of overload of work. Different stressors which might be responsible for this are high work load , narrow time frame , more number of responsibilities at a time etc. This stress becomes an inseparable part of individual’s life. Chronic levels of workplace stress which are not managed successfully leads to burnout syndrome. Awareness of burnout syndrome has increased in last few years. Now it is necessary to find interventions for burnout syndrome. Diaphragmatic breathing and Jacobson’s relaxation technique both are easy to learn and practice treatment techniques, which can be practice in busy schedules also. Many studies target a specific population, as there is paucity of literature targeting school teachers, this study aims at finding effect of diaphragmatic breathing and Jacobson’s relaxation technique in Female School Teachers with Burnout syndrome. Individuals will be assessed pre and post treatment with Burnout Assessment Tool. They will be put on 4 weeks diaphragmatic breathing and Jacobson’s relaxation technique intervention programme. Two objectives of the study are :1.To find effect of diaphragmatic breathing on Burnout using Burnout Assessment Tool. 2.To find effect of Jacobson’s relaxation technique on Burnout using Burnout Assessment Tool. |