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CTRI Number  CTRI/2026/03/105134 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 28/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Emotional Regulation of Dialysis Patients and its effect on Caregiver and Family Dynamics 
Scientific Title of Study   Impact Of Emotional Regulation of Haemodialysis Patients On Caregiver Burden And Family Resilience 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ananya Hariprasad 
Designation  Masters Student 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education

Bangalore
KARNATAKA
560017
India 
Phone  9886227500  
Fax    
Email  ananya.mhsblr2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Jeeshma Vijin 
Designation  Assistant Professor, Department Of Clinical Psychology 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education

Bangalore
KARNATAKA
560017
India 
Phone  8217723829  
Fax    
Email  jeeshma.vijin@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Jeeshma Vijin 
Designation  Assistant Professor, Department Of Clinical Psychology 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education

Bangalore
KARNATAKA
560017
India 
Phone  8217723829  
Fax    
Email  jeeshma.vijin@manipal.edu  
 
Source of Monetary or Material Support  
No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal College of Health Professions,Manipal Academy of Higher Education, Bangalore 560017  
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal,576104 India  
Type of Sponsor  Research institution and hospital 
 
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 
Ananya Hariprasad  Manipal Hospitals, Bangalore  Dialysis Unit, Ground Floor, Manipal Hospitals #98, HAL Old Airport Rd, Kodihalli, Bengaluru 560017, Karnataka
Bangalore
KARNATAKA 
9886227500

ananya.mhsblr2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregiver of dialysis patient 
Patients  (1) ICD-10 Condition: N17-N19||Acute kidney failure and chronic kidney disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients who are undergoing haemodialysis for atleast 3 months.
Caregivers with atleast 3 month history of caregiving
They are the primary caregiver, an immediate family member and uncompensated. 
 
ExclusionCriteria 
Details  Past history of diagnosed psychiatric illness as per medical records
Presence of other life-threatening comorbidities, such as malignant tumors, cardiorespiratory failure, and severe infection.
Home dialysis therapy
Presence of physical disability/ severe mobility issues
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Zarit Burden Interview- ZBI   At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Cognitive Emotional Regulation Questionnaire- CERQ   At Baseline 
Family Resilience Assessment Scale- FRAS  At Baseline 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   24/03/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 Kidney Disease (CKD) is a leading global cause of morbidity and mortality, affecting approximately 843 million people. As CKD progresses to end-stage kidney disease (ESKD), treatments such as haemodialysis (HD) or transplantation become necessary, with HD being the most common in India. HD patients endure physical and psychological challenges, including fatigue, pain, demanding treatment regimens, and a reduced life expectancy. Approximately 45% of HD patients experience psychological issues, mainly depression and anxiety, emphasizing the need to understand emotional regulation in this group.
Emotion regulation refers to the extrinsic and intrinsic processes that help monitor, evaluate, and modify the intensity and duration of emotional reactions.  Maladaptive strategies are linked to poorer quality of life, while adaptive ones show positive outcomes. Understanding how the patient’s emotional regulation strategies affect their caregivers is important given the patient’s high level of dependency. 
Caregivers are those individuals who offer physical, emotional, and social support without financial compensation. They face substantial caregiver burden, including physical strain, emotional pressure, social constraints, and financial difficulties.
This intense caregiving role are often undertaken by close family members and can end up disrupting the family system. However, some families demonstrate the ability to adapt, recover, and grow through adversity showing family resilience. 
Hence, the aim of this study is to explore the specific role of emotion regulation in HD patients, and it’s relationship with caregiver burden and family resilience.
 
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