| CTRI Number |
CTRI/2025/12/099584 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
21/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Integrated Yoga Module on Mental Health and Quality of Life in Cancer Patients |
|
Scientific Title of Study
|
Effect of an Integrated Yoga Module on Mental Health and Quality of Life in Cancer Patients: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishani |
| Designation |
PhD Scholar |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga Science, University of Patanjali Haridwar Uttrakhand Hardwar UTTARANCHAL 249405 India |
| Phone |
9068501683 |
| Fax |
|
| Email |
ishanithakur@uop.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Monika Sharma |
| Designation |
Assistant Professor |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga Science, University of Patanjali Haridwar Uttrakhand Hardwar UTTARANCHAL 249405 India |
| Phone |
9412937920 |
| Fax |
|
| Email |
drmonikasharma@uop.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Ishani |
| Designation |
PhD Scholar |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga Science, University of Patanjali Haridwar Uttrakhand Hardwar UTTARANCHAL 249405 India |
| Phone |
9068501683 |
| Fax |
|
| Email |
ishanithakur@uop.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Yoga Science, University of Patanjali, Haridwar, Uttarakhand, India, 249405 |
|
|
Primary Sponsor
|
| Name |
University of Patanjali |
| Address |
Department of Yoga Science, University of Patanjali, Haridwar, Uttarakhand, India, 249405 |
| Type of Sponsor |
Other [University] |
|
|
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 Deepak Singla |
Indus International Hospital |
Chandigarh Ambala Road, Dera Bassi, Mohali Chandigarh CHANDIGARH |
9068501683
deepak.singla02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Indus International Hospital- Institutional Ethics Committee (IIH-IEC) |
Approved |
| Institutional Ethics Committee, University of Patanjali, Haridwar, Uttarakhand |
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 |
Integrated Yoga Module |
Om chanting, gayatri mantra, maha mrityunjay mantra, karatala sakti vikasaka, angulamula sakti vikasaka, kaphonisakthi vikasaka, manibandha sakti vikasaka, trataka, ashwani mudra, kaki mudra, bhastrika pranayama, nadi shodhana, sheetli pranayam, bhramri pranayam, Haasyasana, shavasana, swadhyaya,Ishvarapranidhana
for 123 days and 60 mins per day |
| Comparator Agent |
Usual care |
Usual care |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with solid tumor malignancy
Currently receiving chemotherapy treatment
Life expectancy less then equals to 6 months
Able to provide informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety, Depression, Quality of Sleep, Cognitive Emotion Regulation Questionnaire, Quality of Life |
Pre-Data: January
Post-Data: April |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="136" Sample Size from India="136"
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)
|
06/01/2026 |
| 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 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
|
This research examines how a structured yoga program can help cancer patients manage psychological stress during chemotherapy. Cancer patients often face significant anxiety, depression, sleep problems, and difficulty coping with their emotions while receiving treatment. Current approaches mainly use medications, which can cause additional side effects and dependency issues. Our study offers a 12-week integrated yoga program specifically designed for patients undergoing active chemotherapy. The program combines gentle physical postures, breathing exercises, meditation, and mindfulness practices adapted to suit the physical limitations and needs of cancer patients. We aim to see whether this yoga intervention can meaningfully reduce anxiety and depression, improve sleep quality, enhance emotional coping skills, and boost overall quality of life. The study will enroll 136 cancer patients from various cancer types who are currently receiving chemotherapy. Participants will be randomly assigned to either receive the yoga program immediately or continue with usual care and receive yoga after the study ends. We will measure changes in mental health, sleep, emotion regulation, and quality of life at the beginning and after 12 weeks. This research addresses a critical gap because most previous studies focused only on breast cancer survivors after treatment ended, not on diverse cancer patients during the challenging active treatment phase. By understanding how yoga helps patients cope during chemotherapy, we hope to provide evidence-based support that can be integrated into routine cancer care to improve patients’ well-being alongside their medical treatment. |