| CTRI Number |
CTRI/2025/12/099910 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Mindfulness Meditation in Gynaecological Cancer Survivors |
|
Scientific Title of Study
|
Impact of Mindfulness Meditation on Neurocognitive Functions in Gynaecological Cancer Survivors: 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 Meenal Bhati |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Obstetrics and Gynecology department, AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9079982186 |
| Fax |
|
| Email |
drmeenalbhati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilanchali Singh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Delhi |
| Address |
Obstetrics and gynecology department
AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811343168 |
| Fax |
|
| Email |
nilanchalisingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilanchali Singh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Delhi |
| Address |
Obstetrics and gynecology department
AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811343168 |
| Fax |
|
| Email |
nilanchalisingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| 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 Nilanchali Singh |
All India Institute of Medical Siences |
Department of obstetrics and gynecology, Mother and child block
New Delhi
DELHI |
9811343168
nilanchalisingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care |
In Routine care we are just following the patients at 3 months of interval and doing their systemic examination on every visit to look for any recurrence. we will not provide any interventions like in the intervention group. |
| Intervention |
Structured Mindfulness Meditation |
Participants in intervention group will perform mindfulness meditation in the morning for 30 minutes and yog nindra session of 20 minutes at night, daily for 6 weeks. The first training session will be in person by a specialist at a designated place. Followed by which 2 weekly supervised meditation session will be conducted in person or online for people living faraway places. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Female |
| Details |
inclusion criteria include: More than 18 years of age, patient who had completed treatment within 1 yr for any gynecological malignancies like carcinoma ovary, uterus, cervix and are able to read hindi or english will be included. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Preexisting psychiatric disorder
2. Preexisting neurocognitive disorder
3. Preexisting neurological disorder
4. History of traumatic brain injury
5. Cancer with brain metastasis
6. Individuals who are already practicing meditation
7. Not willing to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome Measure includes
Change in neurocognitive function scores (reaction time and accuracy) at baseline, 3 and 6 months in intervention and control group |
at baseline, 3months, 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome Measures:
 Levels of BDNF at baseline and 6 months in intervention group
 Correlation of BDNF levels with neurocognitive function scores at baseline and 6 months in intervention group.
 Impact of mindfulness meditation on neurocognitive functions in various types of gynaecological cancer survivors. (Ovarian, uterine and cervical carcinomas: subgroup analysis).
 Impact of mindfulness meditation on sleep, psychological disorders like depression, stress and anxiety among gynecological cancer survivors. |
baseline, 3months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
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)
|
10/01/2026 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Research has demonstrated the beneficial effects of mindfulness meditation, on cognitive functioning and its association with fewer cognitive problems later in life. There is no study in literature where beneficial effect of mindfulness meditation is studied on neurocognitive deficit in gynaecologic cancer survivors. Since it is a randomized controlled trial, the results will be more impactful. Number of patients: 107 in each group 6.3. Inclusion criteria 1. Age > 18 years 2. All gynecological malignancies: carcinoma ovary, uterus, cervix 3. Completed treatment within 12 months at the time of enrollment 4. Consent for study 5. Should be able to read Hindi/English 6.4. Exclusion criteria 1. Preexisting psychiatric disorder 2. Preexisting neurocognitive disorder 3. Preexisting neurological disorder 4. History of traumatic brain injury 5. Cancer with brain metastasis 6. Individuals who are already practicing meditation 7. Not willing to participate 4.1. Primary Objective: To determine the role of mindfulness meditation in improving neurocognitive function of gynaecological cancer survivors by assessing the neurocognitive function scores at 3 and 6 months using both subjective and objective methods. 4.2. Secondary Objective: - To assess the level of BDNF at baseline and 6 months in intervention group
- To correlate BDNF levels with neurocognitive function scores at baseline and 6 months in intervention group
- Impact of mindfulness meditation on neurocognitive functions in various types of gynaecological cancer survivors. (Ovarian, uterine and cervical carcinomas: subgroup analysis).
Impact of mindfulness meditation on Sleep, psychological disorders like depression, stress and anxiety among gynecological cancer survivors. |