| CTRI Number |
CTRI/2025/08/093450 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect Of Guided Meditation in patients on hemodialysis |
|
Scientific Title of Study
|
Study of Effect of Guided Meditation on Spiritual wellbeing and Quality of Life In Patients of End Stage Renal Disease (ESRD) on Maintenance Haemodialysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhalendu Suryakant Vaishnav |
| Designation |
Professor and Head, Department of Medicine, |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department of Medicine, Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat
Professor and Head,Department of Medicine, Pramukhswami Medical College, Bhaikaka University Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9825717481 |
| Fax |
|
| Email |
bhalendusv@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kishanbhai Gohil |
| Designation |
Postgraduate student |
| Affiliation |
Pramukhswami Medical College,Shree Krishna Hospital, Bhaikaka University |
| Address |
Department of Medicine, Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat
Karamsad, Gujarat
Anand
GUJARAT
388325
India |
| Phone |
9737453619 |
| Fax |
|
| Email |
kgohil378@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kishanbhai Gohil |
| Designation |
Postgraduate student |
| Affiliation |
Pramukhswami Medical College,Shree Krishna Hospital, Bhaikaka University |
| Address |
Department of Medicine, Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat
Karamsad, Gujarat
Anand
GUJARAT
388325
India |
| Phone |
9737453619 |
| Fax |
|
| Email |
kgohil378@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Bhalendu Suryakant Vaishnav |
| Address |
Professor and Head,Department of Medicine, Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat. INDIA PIN: 388325 |
| 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 Bhalendu Suryakant Vaishnav |
Shree Krishna Hospital |
Dialysis ward, Second Floor, Department of Medicine
Anand
GUJARAT |
9825717481
bhalendusv@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2, Bhaikaka University, Karamsad, Anand, Gujarat |
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 |
Guided Meditation |
Participants in the intervention group will be provided with pre-recorded Guided meditation through audio device during each dialysis session for 6 weeks. The guided meditation script is based on the steps of Yoganidra, prepared by the investigator. Its duration 15 minutes. |
| Comparator Agent |
Standard Care |
Participants will receive Standard care. They will not be provided guided meditation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of End Stage Renal Disease on Maintenance Hemodialysis |
|
| ExclusionCriteria |
| Details |
Age Less than 18 years.
Age more than 70 years
Active malignancy in last 2 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in score of Kidney Disease Related Quality of Life (KDQOL) assessment tool. |
Baseline and Six Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/09/2025 |
| 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="6"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - THROUGH EMAIL
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Chronic Kidney Disease (CKD) is a common non communicable disease requiring lifelong treatment. It can lead to significant morbidity, social isolation, emotional distress, family strain, and lifestyle disruptions due to therapeutic measures, dietary restrictions and dialysis needs. These challenges significantly impact patients’ and their families’ quality of life. The Kidney Disease Quality of Life (KDQOL) questionnaire is an important tool for assessing the quality of life in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). It evaluates the impact of the disease and its treatment on patients’ physical, mental, and social well-being, helping healthcare providers tailor interventions to improve overall quality of life. Spiritual well-being is a key determinant of quality of life, influencing how individuals cope with illness and life challenges. It can provide a sense of purpose, comfort, and support, which are crucial for overall mental and emotional health. This aspect of well-being is especially important for managing chronic conditions like CKD and ESRD. Meditation is recognized as an important method to enhance spiritual well-being, reduce the psychological burden of chronic diseases, and improve overall well-being. It helps individuals manage stress, gain clarity, and find inner peace, contributing to better mental and emotional health. Dejection and hopelessness are commonly encountered in patients in end stage kidney disease. This study is required to see the tangible difference meditation and spiritual practices can make in improvement of KDQOL, sleep, anxiety, stress and overall attitude of patients in dealing with end stage chronic disease like ESRD. |