| CTRI Number |
CTRI/2025/10/095786 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The effect of spiritual beliefs on the healthcare decision-making of ESKD participants |
|
Scientific Title of Study
|
Exploring Patients perspectives on spirituality in healthcare decision making during maintenance haemodyalysis in India: A qualitative study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASHISH PRABHU |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Renal Replacement Therapy and Dialysis Technology Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8296077489 |
| Fax |
|
| Email |
ashish.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Bharathi |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Renal Replacement Therapy and Dialysis Technology Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008168494 |
| Fax |
|
| Email |
bharathi.parkala@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Bharathi |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Renal Replacement Therapy and Dialysis Technology Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008168494 |
| Fax |
|
| Email |
bharathi.parkala@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Haemodialysis Unit Department of Nephrology Kasturba Hospital Kasturba Medical college Manipal Manipal Academy of Higher Education Manipal 576104 udupi Karnataka India |
|
|
Primary Sponsor
|
| Name |
Ashish Prabhu |
| Address |
Department of Renal Replacement Therapy and Dialysis Technology 5 th floor Manipal College of Health Prpfessions Manipal Academy of Higher Education Manipal 576104 Udupi Karnataka India |
| 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 |
| Dr Anuja Damani |
Kasturba Hospital |
Department of Nephrology Dialysis Unit 3 rd floor Kasturba Hospital Manipal
Udupi
KARNATAKA |
9158437827
anuja.damani@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are on maintenance haemodialysis for more than or equal to 6 months
languages kannada and english |
|
| ExclusionCriteria |
| Details |
patients who are unable to give consent or who refuse to participate in the study
post renal transplantation
patients who are unable to communicate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the perspective of Spirituality on Haemodialysis patients during health care decision-making using thematic analysis |
Baseline |
|
|
Secondary Outcome
|
|
|
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)
|
03/11/2025 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Informed consent will be obtained from all participants prior to commencing the study and for the purpose of audio recording the interviews. The interviews will be conducted in either English or Kannada, depending on the participant’s language preference, to ensure clarity and comfort during the discussion. Each interview will take place in a separate, quiet room to maintain privacy and confidentiality. The interview will explore participants’ perspectives on spirituality and healthcare decision-making. The duration of each session will be approximately 30 to 40 minutes. All audio-recorded interviews will later be transcribed and translated into English for analysis. The data will then be analyzed thematically using Braun and Clarke’s framework, either through manual coding or with the assistance of NVivo software. |