| CTRI Number |
CTRI/2024/11/076843 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Mountain meditation for spiritual wellbeing of cancer patients |
|
Scientific Title of Study
|
Effect of a single-session of mindfulness-based mountain meditation on the spiritual well-being of patients scheduled for cancer surgery: A randomized controlled 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 Anjali Mangesh Joshi |
| Designation |
Yoga Therapist |
| Affiliation |
HCG Cancer Center, Nagpur |
| Address |
3rd Floor, Research department, Khasra No. 50,51, Mouja Wanjri, Bande Nawaz Nagar, Near Automotive Square, Kalamna Ring Road
Nagpur
MAHARASHTRA
440026
India |
| Phone |
8805452364 |
| Fax |
|
| Email |
dranjali.j@hcgel.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Mangesh Joshi |
| Designation |
Yoga Therapist |
| Affiliation |
HCG Cancer Center, Nagpur |
| Address |
3rd Floor, Research department, Khasra No. 50,51, Mouja Wanjri, Bande Nawaz Nagar, Near Automotive Square, Kalamna Ring Road
Nagpur
MAHARASHTRA
440026
India |
| Phone |
8805452364 |
| Fax |
|
| Email |
dranjali.j@hcgel.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Mangesh Joshi |
| Designation |
Yoga Therapist |
| Affiliation |
HCG Cancer Center, Nagpur |
| Address |
3rd Floor, Research department, Khasra No. 50,51, Mouja Wanjri, Bande Nawaz Nagar, Near Automotive Square, Kalamna Ring Road
Nagpur
MAHARASHTRA
440026
India |
| Phone |
8805452364 |
| Fax |
|
| Email |
dranjali.j@hcgel.com |
|
|
Source of Monetary or Material Support
|
| HCG Cancer Center, Khasra No.50,51, Mouja Wanjri, Bande Nawaz Nagar, Near
Automotive Square, Kalamna Ring Road, Nagpur - 440026 |
|
|
Primary Sponsor
|
| Name |
HCG Cancer Center Nagpur |
| Address |
Khasra No.50,51, Mouja
Wanjri, Bande Nawaz Nagar, Near Automotive Square, Kalamna
Ring Road
Nagpur
MAHARASHTRA
440026
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anjali Joshi |
HCG Cancer Center |
4th floor, Pre-op area, Intensive Care Unit, Khasra No.50, 51, Mouja Wanjri,Bande Nawaz Nagar, Near
Automotive Square, Kalamna Ring Road, Nagpur - 440026,
Maharashtra, India
Nagpur
MAHARASHTRA |
8805452364
dranjali.j@hcgel.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HCG NCHRI Cancer Center Institutional Ethics Committee |
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 |
| Comparator Agent |
Control |
The control group will receive standard medical care. |
| Intervention |
Mountain meditation |
The intervention group will practice a single, supervised 10-minute session of guided MM immediately before their surgery, using guided audio instructions. The practice will involve visualizing the self as a mountain and embodying the unwavering stillness, strength, and groundedness of the mountain. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for all types of cancer surgery, with confirmed diagnosis of cancer
Between 18 and 65 years of age
Functional ability, as per ECOG (Eastern Cooperative Oncology Group) scores 0 to 2
Patients consenting to participate in the study |
|
| ExclusionCriteria |
| Details |
Respiratory distress
Physical restrictions/disability preventing patient participation in the study
Cognitive impairment
Major psychiatric or neurological illness
Hearing impairment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spiritual wellbeing |
Baseline and same day before surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure, Respiratory rate and Heart rate |
Baseline and same day before surgery |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Introduction Cancer patients undergoing surgery have high levels of preoperative distress. Spiritual well-being (SWB) has a vital role in emotional well-being, happiness, optimism, and psychosocial adjustment related to cancer surgery. Mountain meditation (MM) is a mindfulness-based meditation, that fosters tranquility, stability, and inner strength to cope with the challenges of life. This study aims to evaluate the effect of a single session of MM on SWB in patients scheduled for cancer surgery. Methodology N=72 cancer patients will be randomly assigned to the intervention group (N=36) or control group (N=36). The intervention group will practice a single, supervised 10-minute session of guided MM immediately before their surgery, using guided audio instructions. The practice will involve visualizing the self as a mountain and embodying the unwavering stillness, strength, and groundedness of the mountain. The control group will receive standard medical care. FACIT-SP12 (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale) will be used to evaluate SWB at baseline and after a single session of MM. Objective measures of assessments will include blood pressure, heart rate and respiratory rate. Data will be analyzed, results will be interpreted and conclusions will be drawn. Clinical implications This study will explore the potential role of MM as a psycho-spiritual prehabilitation intervention in the surgical oncology setting. Integrating it into the conventional treatment protocol can provide patient-centered care specific to their unmet spiritual needs. MM can be an easily accessible, brief, safe, cost-effective, and novel approach to immediately reduce preoperative anxiety, improve preparedness for surgery, and potentially enhance surgical outcomes in cancer patients scheduled for surgery. |