| CTRI Number |
CTRI/2025/01/079589 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Psychosocial Factors in Post-Intensive Care Syndrome-Family |
|
Scientific Title of Study
|
Psychosocial Factors in Post-Intensive Care Syndrome-Family: Cross-Sectional Exploration in Critical Care. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TULIKA SHARMA |
| Designation |
PhD Research Scholar |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur. |
| Address |
Lal Bahadur Shastri Block, Department of Clinical Psychology, 1st floor, Department of Clinical Psychology, Mahatma Gandhi UNiversity of Medical Sciences and Technology, Jaipur.
Jaipur RAJASTHAN 302001 India |
| Phone |
9680484168 |
| Fax |
|
| Email |
sharmatulika99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sunita Purty |
| Designation |
HOD and Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur. |
| Address |
Lal Bahadur Shastri Block, Department of Clinical Psychology, 1st floor, Department of Clinical Psychology, Mahatma Gandhi UNiversity of Medical Sciences and Technology, Jaipur.
Jaipur RAJASTHAN 302022 India |
| Phone |
9685677129 |
| Fax |
|
| Email |
Sunitarnps9@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sunita Purty |
| Designation |
HOD and Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sceinces and Technology, Jaipur |
| Address |
Lal Bahadur Shatri Block, Department of Clinical Psychology, 1st floor, Department of Clinical Psychology, Mahatma Gandhi University of Medical Sciences and Technology, Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
9685677129 |
| Fax |
|
| Email |
Sunitarnps9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi University of Medical Sciences and Technology, Jaipur. |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur. |
| Address |
Mahatma Gandhi Rd, Ricco Industrial Area, Sitapura, Jaipur, Ramchandrapura, Rajasthan. 302022 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| TULIKA SHARMA |
Mahatma Gandhi University of Medical Sciences & Technology |
Department of Critical Care, counselling room, Mahatma Gandhi Rd, Ricco Industrial Area, Sitapura, Jaipur, Ramchandpura, Rajasthan 302022 Jaipur RAJASTHAN |
9680484168
sharmatulika99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi University of Sceinces and Technology, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NO |
NO |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Family caregiver who are present and providing care to an ICU patient during their hospitalization.
Patient duration should be at least 3 days stay in the ICU.
Family caregiver who have a 1st degree and 2nd degree relationship with the ICU patient, such as spouses, parents, siblings, or adult children, uncle, aunt, grand-parents, grand-children, nephew, niece, half-parent, half-children and half-sibling living with the patient for at least 1 year.
Family caregivers aged 18 years or older.
Family caregivers who have working knowledge of English and Hindi language
Family caregivers who have provided care for at least 1 month prior to ICU stay and who will continue providing care for a specified period following discharge.
|
|
| ExclusionCriteria |
| Details |
• Exclude individuals who are not directly involved in caregiving responsibilities for the ICU patient, such as distant relatives, acquaintances or non-relatives.
• Caregivers with less than 1 month experience of caregiving to a patient.
• Patients admitted in the ICU with Road Traffic Accident cases, poisoning or drug overdose cases, suicidal cases, or any other traumatic injuries will be excluded from study.
• Family caregivers aged below18 years.
• Exclude individuals who are unable to provide informed consent for participation in the study, such as those with cognitive impairments or legal incapacity.
• Exclude individuals who are unable to effectively communicate in the language(s) used for data collection or who have significant communication barriers that may impede participation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post Intensive Care Syndrome-Family |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Caregiver Mastery, Caregiver Quality of life, Spritual, Religious and Personal Beliefs, Coping |
one Point |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
01/02/2025 |
| 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="1" Months="11" Days="30" |
|
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
research seeks to address a critical gap in the existing literature by focusing
on Post-Intensive Care Syndrome-Family (PICS-F), an area that has received
scant attention despite the growing recognition of its significance worldwide.
While the psychological toll experienced by family caregivers of ICU patients
is increasingly acknowledged, there is a notable absence of studies delving
into this crucial domain. Existing research primarily focuses on coping
strategies and mental health outcomes, overlooking the broader spectrum of
psychosocial variables that may impact PICS-F.
This
study aims to fill this void by employing quantitative research methods to
explore the intricate interplay of various psychosocial factors, including
religious and spiritual beliefs, caregiver mastery, coping strategies, carer
quality of life, and mental health status among family caregivers of ICU
patients. By conducting a comparative analysis across different ICU settings,
the research also intends to shed light on contextual factors influencing the
manifestation of PICS-F, thereby facilitating the development of culturally
sensitive interventions tailored to the unique needs of family caregivers.
Moreover,
while previous research, particularly in the Indian context, has predominantly
focused on systematic reviews without delving into quantitative studies, this
research seeks to bridge this gap by providing empirical evidence specific to
the Indian population. By offering a comprehensive understanding of PICS-F and
its determinants, this study aims to inform clinical practice, policy
formulation, and academic research, ultimately paving the way for
evidence-based interventions that enhance the well-being of family caregivers
and optimize patient outcomes in critical care settings. Through fostering a
culture of compassionate and holistic care, this research endeavors to catalyze
a paradigm shift in supporting family caregivers of ICU patients, promoting
well-being amidst the challenges they face. |