| CTRI Number |
CTRI/2019/06/019895 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
15/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Phenomenological Study |
| Study Design |
Other |
|
Public Title of Study
|
Lived experiences of caregivers of ICU patients. |
|
Scientific Title of Study
|
A phenomenological study on lived experiences of caregivers of patients admitted in Main ICU at Nehru hospital, PGIMER, Chandigarh 2018-20 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha Sharma |
| Designation |
MSc.Nursing 1st year |
| Affiliation |
National Institute of Nursing Education,PGIMER,Chandigarh,Pin 160012,(India) |
| Address |
National Institute of Nursing Education,PGIMER, Chandigarh 160012
Chandigarh
CHANDIGARH
161002
India |
| Phone |
7814879912 |
| Fax |
|
| Email |
deekshasharma7303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti |
| Designation |
Lecturer |
| Affiliation |
National Institute of Nursing Education,PGIMER,Chandigarh,Pin 160012,(India) |
| Address |
National Institute of Nursing Education,PGIMER, Chandigarh 160012
Chandigarh
CHANDIGARH
161002
India |
| Phone |
8437748011 |
| Fax |
|
| Email |
sXXXXXX011pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti |
| Designation |
Lecturer |
| Affiliation |
National Institute of Nursing Education,PGIMER,Chandigarh,Pin 160012,(India) |
| Address |
National Institute of Nursing Education,PGIMER, Chandigarh 160012
Chandigarh
CHANDIGARH
161002
India |
| Phone |
8437748011 |
| Fax |
|
| Email |
sXXXXXX011pgi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
PGIMER Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PGIMER Chandigarh |
PGIMER Chandigarh 160012 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shruti |
Postgraduate Institute of Medical Education and Research PGIMER Chandigarh 160012 |
National Institute of Nursing Education PGIMER Chandigarh 160012
Chandigarh
CHANDIGARH |
8437748011
shruti2011pgi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics Committee |
Approved |
| PGIMER Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of ICU Patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers of patients admitted in ICU who:-
- are involved in routine care (>3 days a week for > 2 weeks)
- are willing to participate in the study
- can understand and speak Hindi or english |
|
| ExclusionCriteria |
| Details |
Caregivers who are having cognitive or thought disturbances and paid caregivers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Information regarding the lived experiences of the caregivers of ICU patients |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Information regarding how to improve family centred nursing care |
3 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published in Nursing and Midwifery Research Journal,Vol-16,no.4, October 2020 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The purpose of the study is to explore the lived experiences of the informal caregivers of the ICU patients. |