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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bhalendusv@charutarhealth.org].

  6. 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.

  7. 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.

 
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