| CTRI Number |
CTRI/2025/10/096232 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Guided Meditation for Spiritual wellbeing of Cancer patients |
|
Scientific Title of Study
|
Effect of Guided Meditation on Psychological well-being and Spiritual well-being in
Cancer Patients A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhalendu Vaishnav |
| Designation |
Professor and Head, Department of Medicine, |
| Affiliation |
Pramukhswami Medical College, Bhaikaka University |
| Address |
OPD 108, Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat OPD 108, Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat Anand GUJARAT 388325 India |
| Phone |
9825717481 |
| Fax |
|
| Email |
bhalendusv@charutarhealth.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bhalendu Vaishnav |
| Designation |
Professor and Head, Department of Medicine, |
| Affiliation |
Pramukhswami Medical College, Bhaikaka University |
| Address |
OPD 108, Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat OPD 108, Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat Anand GUJARAT 388325 India |
| Phone |
9825717481 |
| Fax |
|
| Email |
bhalendusv@charutarhealth.org |
|
Details of Contact Person Public Query
|
| Name |
dr Dhruv Brahmbhatt |
| Designation |
Postgraduate student Department of Medicine, |
| Affiliation |
Pramukhswami Medical College, Bhaikaka University |
| Address |
M.S.Patel Cancer center, Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat
Anand GUJARAT 388325 India |
| Phone |
7575079878 |
| Fax |
|
| Email |
dhruvsb@bhaikakauniv.edu.in |
|
|
Source of Monetary or Material Support
|
| Pramukhswami Medical College, Bhaikaka University, Karamsad, Gujarat, INDIA. PIN: 388325 |
|
|
Primary Sponsor
|
| Name |
Dr Bhalendu Suryakant Vaishnav |
| Address |
Department of Medicine,Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat |
| 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 Vaishnav |
M.S.Patel Cancer Center, Shree Krishna Hospital |
Karamsad 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: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guided Meditation |
• Guided spiritual meditation (10–15 min audio sessions) recorded by PI and delivered at least three days/week for 6 weeks by audio device
|
| Comparator Agent |
Nil. |
Patients in control group will receive standard care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from stage 3 and 4 cancer |
|
| ExclusionCriteria |
| Details |
Severe psychiatric illness (e.g., psychosis, major depression)
Cognitive impairment (e.g., dementia)
Terminal illness (e.g., organ failure)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Psychological general wellbeing and Spiritual Wellbeing in these patients.
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
24/11/2025 |
| 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="1" Months="0" 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 - 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 - Proposals should be directed to [bhalendusv@charutarhealth.org].
- For how long will this data be available start date provided 01-12-2026 and end date provided 31-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Advanced cancer presents not only a physiological
burden but also profound psychological and existential distress, often
diminishing patients’ quality of life (QoL) despite optimal medical management.
As the focus of care shifts toward palliation and holistic well-being,
integrative interventions such as guided meditation have gained prominence for
their potential to alleviate suffering and enhance inner resilience. Rooted in
ancient contemplative traditions, guided meditation offers a structured approach
to cultivating present-moment awareness, emotional regulation, and spiritual
grounding—dimensions increasingly recognized as vital in end-of-life care.
Recent evidence underscores its efficacy in reducing anxiety, pain perception,
and emotional turmoil, thereby contributing to improved QoL outcomes in
oncology settings.
A meta-analysis by Nguyen et al. demonstrated that
non-pharmacological interventions, including mindfulness-based practices,
yielded statistically significant improvements in QoL across various cancer
types, particularly when integrated early and consistently
Against this backdrop, the present study aims
to evaluate the impact of guided meditation on the QoL of patients with
advanced cancer, offering empirical insights into its therapeutic value and
potential for integration into mainstream palliative protocols. |