| CTRI Number |
CTRI/2025/08/092679 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Psycho-social Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Psycho-social intervention to improve resilience in caregivers |
|
Scientific Title of Study
|
Psycho-social palliative care intervention on resilience among caregivers of children with chronic illnesses |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arvind Kumar Sharma |
| Designation |
PhD Research Scholar |
| Affiliation |
Indira Gandhi National Open University, New Delhi |
| Address |
Block - 15, School of Social Work, Indira Gandhi National Open University, Maidan Garhi
South
DELHI
110068
India |
| Phone |
7042463123 |
| Fax |
|
| Email |
scholararvind@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Diwakar G |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi National Open University, New Delhi |
| Address |
Room No 8, School of Social Work, Block 15, Section H, Indira Gandhi National Open University, Maidan Garhi
South
DELHI
110068
India |
| Phone |
8547342398 |
| Fax |
|
| Email |
dilipdiwakar@ignou.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Arvind Kumar Sharma |
| Designation |
PhD Research Scholar |
| Affiliation |
Indira Gandhi National Open University, New Delhi |
| Address |
Block - 15, School of Social Work, Indira Gandhi National Open University, Maidan Garhi
South
DELHI
110068
India |
| Phone |
7042463123 |
| Fax |
|
| Email |
scholararvind@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Arvind Kumar Sharma |
| Address |
Block - 15, School of Social Work, Indira Gandhi National Open University, Maidan Garhi, New Delhi-110068, India |
| Type of Sponsor |
Other [SELF] |
|
|
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 Mamta Parihar |
MDM Hospital, Jodhpur |
Room No. 14, Govt College of Nursing, Dr SN Medical College, Jodhpur
Jodhpur
RAJASTHAN |
9529794077
mamtaparihar2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. S. N. Medical College, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Psycho-social burden and grief |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Active Intervention |
Routine supportive care
Total Duration will be 1 year. |
| Intervention |
Psycho-social Intervention |
Psychoeducation, emotional coping, cognitive restructuring, self-care enhancement, social support, communication, resilience-building, problem-solving, and anticipatory grief management.
Total duration will be 1 year. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants who are residents of Jodhpur or staying in Jodhpur for the treatment during the intervention.
2. Only the participants who are Primary caregivers of the child (0-18 years).
3. Participants who are willing and have given their consent for intervention study.
4. Participants who can read and write Hindi language. |
|
| ExclusionCriteria |
| Details |
1. Caregivers whose patient (Child) is eminently dying.
2. Minor caregivers (less than 18) will not be included.
3. Persons who care for the patient for a short time or substitute for the main caregivers.
4. The professional caregivers or hired caregivers will not be included. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The caregiver burden, resilience, anticipatory grief, and perceived social support will be assessed. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/09/2025 |
| 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="2"
Months="6"
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
|
This study aims to evaluate the effectiveness of a structured psycho-social palliative care intervention in enhancing resilience among caregivers of children with chronic illnesses. Caregivers often experience high levels of stress, burden, and anticipatory grief, which can negatively impact both their well-being and the quality of care provided to the child. This experimental study will be conducted in the community setting of Jodhpur, Rajasthan, with a total of 120 participants, randomly allocated into intervention and control groups. The intervention group will receive two individual and three group psycho-social sessions focusing on resilience-building, emotional support, and coping strategies. Standardized tools will be used to measure resilience, caregiver burden, grief, and perceived social support before and after the intervention. Ethical approval has been obtained from the IEC, Dr. S.N. Medical College, Jodhpur. The findings are expected to inform future models of family-centered palliative care for chronically ill children in community settings. H1: There will be a significant association between Resilience Scores and demographic variables for caregivers of children with chronic illness. H2: Caregivers of children with chronic illnesses will have improved resilience after exposure to the intervention. H3: There will be a reduced level of burden among caregivers of children with chronic illness after exposure to the intervention. H4: There will be a reduced level of anticipatory grief among caregivers of children with chronic illness after exposure to the intervention. H5: Caregivers of children with chronic illness will have better perceived social support after exposure to the intervention. H6: There will be a significant difference in the Resilience, caregiver burden, anticipatory grief, and perceived social support Scores between the experimental and control groups of participants |