| CTRI Number |
CTRI/2025/06/089554 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Experience of patients undergoing hemodialysis |
|
Scientific Title of Study
|
Lived Experience of Patient Undergoing Hemodialysis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P TRIVENI |
| Designation |
Post Graduation Student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing Kankanady Mangaluru.
Department of Medical Surgical Nursing 4th floor
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7483790969 |
| Fax |
|
| Email |
trivenip2812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JUBEE JOSEPH |
| Designation |
Associate Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing Kankanady Mangaluru.Department of Medical Surgical Nursing 4th floor
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8722831688 |
| Fax |
|
| Email |
jubeejoseph@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
JUBEE JOSEPH |
| Designation |
Associate Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing Kankanady Mangaluru.Department of Medical Surgical Nursing 4th floor
KARNATAKA
575002
India |
| Phone |
8722831688 |
| Fax |
|
| Email |
jubeejoseph@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| The study will be conducted in Father Muller Medical College Hospital at Dialysis unit. |
|
|
Primary Sponsor
|
| Name |
P Triveni |
| Address |
Father Muller College of Nursing Mangaluru.Dakshina Kannada Dist,Karnataka India 575002 |
| 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 |
| JUBEE JOSEPH |
Father Muller Medical College Hospital |
Depatment of Medical Surgical Nursing,4th floor
Dakshina Kannada
KARNATAKA |
08722831688
jubeejoseph@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are:
1.above 18 years undergoing hemodialysis.
2.able to participate in the interviews and able to communicate in Kannada or English
|
|
| ExclusionCriteria |
| Details |
Patients who are:
- undergoing hemodialysis for less than six months
-delirious, unable to provide verbal information
-critically ill patients admitted to ICUs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Explore the lived Experience of patients undergoing hemodialysis. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Explore the lived experience of patients undergoing hemodialysis and bring out needed changes in healthcare facilities. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
14/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The
research is regarding lived experience of patients undergoing hemodialysis;The
goal of this study is to determine the population’s health needs and gain
insight into how their lives have changed in all areas since starting
hemodialysis. Maybe getting to know patients’ lives and understanding their
subjective experiences in hemodialysis units could lead to common themes that
could enable a long-lasting intervention and serve as the basis for enacting
social change.
|