| CTRI Number |
CTRI/2023/07/054723 [Registered on: 04/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Psychosocial Effect of Pediatric illness on family |
|
Scientific Title of Study
|
Psychosocial Impact of Chronic Pediatric illness on family: An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bimla Sharma |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Institute of anaesthesiology, pain and perioperative medicine, Old Rajinder Nagar, New Delhi
Central
DELHI
110060
India |
| Phone |
9810135366 |
| Fax |
|
| Email |
bimsharma1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bimla Sharma |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Institute of anaesthesiology, pain and perioperative medicine, Old Rajinder Nagar, New Delhi
Central
DELHI
110060
India |
| Phone |
9810135366 |
| Fax |
|
| Email |
bimsharma1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bimla Sharma |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Institute of anaesthesiology, pain and perioperative medicine, Old Rajinder Nagar, New Delhi
Central
DELHI
110060
India |
| Phone |
9810135366 |
| Fax |
|
| Email |
bimsharma1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Institute of anaesthesiology, pain and perioperative medicine, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi |
| 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 |
| Bimla Sharma |
Sir Ganga Ram Hospital |
Pediatric ward, SGRH old rajendra nagar
Central
DELHI |
9810135366
bimsharma1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Comittee, Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.The study cohort will consist of parents of children with chronic diseases including malignancy.
2.Parents of children aged 2 to 18 years with an established diagnosis of a chronic illness. |
|
| ExclusionCriteria |
| Details |
1.Parental refusal to participate in the study.
2.Parents suffering from major depressive disorders before the diagnosis of illness in the child.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the psychosocial impact of children’s chronic illness on their families using the IOF scale. |
day one |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find out the incidence of depressive symptoms in the parents of the affected children.
2.To investigate the association between parent-reported depressive symptoms, socio- demographic factors & impact on families
3.To compare the psychosocial impact in parents of children with malignancy with other chronic diseases |
Day one |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/07/2023 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Chronic pediatric illnesses especially malignant conditions have a huge psychosocial and financial impact on the family. The goals of pediatric palliative care are to ensure the best possible quality of life of the child as well as their caregivers by addressing the physical and psychological needs of the child and providing support to the family. Parents with depressive symptoms should receive particular attention to provide supportive care in their children’s pediatric palliative care programs. Evidence on family-supportive care in pediatric palliative care research is scarce. We aim to study the impact of the children’s disease on their families and assess their unmet needs by applying the Impact of Family Scale (IOF). The Center for Epidemiologic Studies Depression scale (CES-D) will be used to assess the depressive symptoms in the parent. By identifying those affected, referral to a clinical psychologist will be made which will help in providing better counselling services and psychological support. This will help us to address their issues and to formulate an effective and holistic palliative care plan. |