| 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
|
|
|
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
|
|
|
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. |