| CTRI Number |
CTRI/2020/04/024895 [Registered on: 28/04/2020] Trial Registered Prospectively |
| Last Modified On: |
27/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Stress and care giving burden ,Empowerment programme |
|
Scientific Title of Study
|
A study to assess the effectiveness of Empowerment programme on Stress and Care giving Burden among Care givers of Chronically ill patients admitted in MMIMSR, Mullana, Ambala, Haryana. |
| Trial Acronym |
Interventional |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Youssouf |
| Designation |
Post graduate student |
| Affiliation |
MM college of Nursing, Mullana, Ambala |
| Address |
M.M College of Nursing
Ambala
HARYANA
133207
India
MM college of Nursing, Mullana, Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
8126509944 |
| Fax |
|
| Email |
shaliniyussouf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanika Rai |
| Designation |
Head of Department of Medical Surgical Nursing |
| Affiliation |
MM college of Nursing, Mullana, Ambala |
| Address |
MM college of Nursing, Mullana, Ambala
MM college of Nursing, Mullana, Ambala
Ambala
HARYANA
134003
India |
| Phone |
9872820564 |
| Fax |
|
| Email |
nehukanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Youssouf |
| Designation |
Msc Nursing |
| Affiliation |
MM college of Nursing, Mullana, Ambala |
| Address |
M.M COllege of Nursing ,Mullana,Ambala, HARYANA
MM college of Nursing, Mullana, Ambala
HARYANA
133207
Ambala
HARYANA
133207
India |
| Phone |
8126509944 |
| Fax |
|
| Email |
shaliniyussouf@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shalini Youssouf |
| Address |
M.M. College of Nursing, Mullana, Ambala |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Shalini Youssouf |
M.M. College of Nursing, Mullana, Ambala |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shalini Youssouf |
MM Hospital, Mullana, Ambala |
Surgery and Medicine ward, 1st and 2nd floor
Ambala
Ambala
HARYANA
Ambala
HARYANA |
8126509944
shaliniyussouf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronically ill |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Empowerment programme |
It includes orientation video of hospital, Progressive muscle relaxation technique session,demonstration of oral and bed bath procedure and group discussion |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
67.00 Year(s) |
| Gender |
Both |
| Details |
ï½ Above 18 years of age.
ï½ Primary caregiver or key caregiver of the chronically ill admitted patient (Person responsible for providing care to the index case on the day to day basis most of the time).
|
|
| ExclusionCriteria |
| Details |
ï‚´ Not Willing to participate in the study
ï‚´ not able to attend the complete intervention
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| stress and care giving burden will be reduced |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| care giving burden will be reduced |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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 1 |
|
Date of First Enrollment (India)
|
30/04/2020 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
This is a quantitative approach wit quasi experimental non equivalent control group design . The study is to assess the effectiveness of empowerment programme on stress and care giving burden among care givers of chronically ill patients at MMIMS&R. Stress and care giving burden of care givers was assessed on the basis of ground work done in the different wards. Intervention will be given for four days and post test will be taken immediately and after 15 days of intervention. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A study to assess the effectiveness of Empowerment programme on stress and care giving burden of care givers of chronically ill patients admitted at MMIMS&R hospital. A quantitative research approach was used by using quasi experimental . Experimental and comparison group are used. Sampling technique used for the study was Convenience sampling technique for the care givers. Empowerment programme was given to the care givers to reduce there care giving burden and stress . |