| CTRI Number |
CTRI/2020/04/024618 [Registered on: 14/04/2020] Trial Registered Prospectively |
| Last Modified On: |
08/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the effects of a training program in reducing work related stress(Compassion Fatigue, Burnout and Secondary Traumatic Stress) among nurses working in hospital |
|
Scientific Title of Study
|
Effectiveness of Education based Resiliency Programme in Reducing Compassion Fatigue, Burnout and Secondary Traumatic Stress among Nurses in a Tertiary Care Hospital: A Pre-Post Interventional Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha Sinha |
| Designation |
MPH Trainee |
| Affiliation |
Jawaharlal Institue Of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Preventive and Social Medicine
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9546829681 |
| Fax |
|
| Email |
ishasinha250@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Isha Sinha |
| Designation |
MPH Trainee |
| Affiliation |
Jawaharlal Institue Of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Preventive and Social Medicine
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9546829681 |
| Fax |
|
| Email |
ishasinha250@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh Kumar |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institue Of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Preventive and Social Medicine
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487896551 |
| Fax |
|
| Email |
sssgan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research,
JIPMER campus road,
Gorimedu,
Dhanvantari nagar,
Puducherry,
605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Puducherry |
| 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 |
| Isha Sinha |
JIPMER |
Department of Social and Preventive Medicine,
JIPMER
Pondicherry
PONDICHERRY |
9546829681
ishasinha250@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
behavioral intervention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Education based resiliency programme |
Power point,Video and pamphlets
Participants will be contacted one time for intervention and reassessed after 2 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Having an experience of minimum 1 year
2. Nurses providing direct care to the patients(nursing officers) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Compassion Fatigue, Burn Out and Secondary Traumatic Stress level after education based program |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="363"
Sample Size from India="363"
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)
|
15/04/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an interventional study to assess the effectiveness of an education based resiliency programme in reducing compassion fatigue, burnout and secondary traumatic stress among nurses of a tertiary care hospital Puducherry. The primary outcome will be reduced level of compassion fatigue, burnout and secondary traumatic stress 2 months after intervention.
|