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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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