| CTRI Number |
CTRI/2025/12/099624 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Psychological distress and quality of life of family caregivers of patients with silicosis |
|
Scientific Title of Study
|
Analysis of psychological distress and its impact on the quality of life of primary caregiver of patient suffering from silicosis at a tertiary care center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhanu Choudhary |
| Designation |
Junior Resident |
| Affiliation |
Jawahar Lal Nehru Medical College, Ajmer |
| Address |
Department of Palliative Medicine, Jawaharlal Nehru Medical College and Hospital, Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9461220089 |
| Fax |
|
| Email |
choudharybhanu24596@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deepak kumar garg |
| Designation |
Associate professor and Head of department |
| Affiliation |
jawahar lal nehru medical college ajmer |
| Address |
Department of palliative medicine, Jawahar lal nehru medical college and hospital, ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
|
| Fax |
|
| Email |
mebhanu99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhanu Choudhary |
| Designation |
Junior Resident |
| Affiliation |
Jawahar Lal Nehru Medical College Ajmer |
| Address |
Department of Palliative Medicine, Jawaharlal Nehru Medical College and Hospital, Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9461220089 |
| Fax |
|
| Email |
choudharybhanu24596@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhanu Choudhary |
| Address |
Department of Palliative Medicine, Jawaharlal Nehru Medical College, Ajmer, Rajasthan, India, 305001 |
| 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 Bhanu Choudhary |
Jawahar Lal Nehru Medical College and Hospital, Ajmer |
Department of Palliative Medicine and Respiratory Medicine, Kala Bagh, Ajmer, Rajasthan, 305001
Ajmer
RAJASTHAN |
9461220089
choudharybhanu24596@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jawahar lal nehru medical college, ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
primary family caregiver aged above 18 years, of either gender and willing to participate of patients diagnosed with silicosis |
|
|
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 |
Who are aged above 18 years, certified silicosis diagnosis of patient, able to communicate |
|
| ExclusionCriteria |
| Details |
not able to understand and answer the questionnaires, drug abusers, significant comorbidities that affect the quality of life |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the level of psychological distress and its impact on quality of life of primary caregivers of patients suffering from silicosis. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify socio-demographic variables of patients & their primary caregivers |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
31/12/2025 |
| 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="0"
Months="2"
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
|
Caregiving stress manifests as
familial tensions and pressure, arising from
the mismatch between caregiving responsibilities and actual capabilities.
Families find themselves in overwhelming situations, grappling with mental and
psychological confusion, which poses a threat to their overall well-being. It’s crucial for family members to assess
their stress levels and prioritize their health. This study aims to analyze
psychological challenges faced by primary caregivers and reciprocal
relationship between caregiver distress and patient well-being in the context
of silicosis. Through this study, the research seeks to identify potential
areas for intervention and support that can enhance the overall quality of life for both caregivers and patients
affected by silicosis, ultimately contributing
to the development of more effective strategies for comprehensive care and support
in tertiary care settings. |