| CTRI Number |
CTRI/2022/02/040592 [Registered on: 24/02/2022] Trial Registered Prospectively |
| Last Modified On: |
20/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Mindfulness Meditation along with Physiotherapy for managing Insomnia and Pain in Gynaecological cancer patients -A clinical trial |
|
Scientific Title of Study
|
Mindfulness meditation along with physiotherapy for managing insomnia and pain in gynaecological cancer patients-a clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayatri Landge |
| Designation |
Post-graduate student |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
Department of oncology physiotherapy, JNMC campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8806477430 |
| Fax |
|
| Email |
gayatrilandge97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashwini Bulbuli |
| Designation |
Guide |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
Department of OBG physiotherapy, JNMC campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9916043325 |
| Fax |
|
| Email |
ashwinichougala05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gayatri Landge |
| Designation |
Post-graduate student |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
Department of oncology physiotherapy, JNMC campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8806477430 |
| Fax |
|
| Email |
gayatrilandge97@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital and MRC Nehru Nagar Belagavi |
|
|
Primary Sponsor
|
| Name |
Gayatri Landge |
| Address |
KAHER institute of physiotherapy, JNMC campus, Nehru Nagar, Belagavi |
| 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 |
| GayatriLandge |
Dr. Prabhakar Kore Hospital |
KAHER Institute of physiotherapy ,Belagavi, Department of Oncology, JNMC campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA |
8806477430
gayatrilandge97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KLEU Institute of Physiotherapy Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness meditation along with physiotherapy |
The intervention will be conducted for 3 sessions; for 1 week. During 1st session fundamental mindfulness skills such as breath awareness, awareness of thoughts and emotions, body scans, sitting meditation and forgiving meditation will be given. In the 2nd and 3rd session, discussion of issues concerning sleep with participant’s experience related to insomnia and pain will be done. According to their issues the moment to moment awareness in the participant’s live and utilization of the process associated with mindfulness throughout the day will be encouraged. In each session routine physiotherapy protocol of strengthening exercises for the pelvic floor muscles and transverse abdominis muscles, stretching exercises for muscles attached to the pelvic girdle, and diaphragmatic breathing technique will be given before the mindfulness meditation program.
The intervention will be given for 3 alternative days in a week for 45 minutes.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Participants diagnosed with any type of
gynecological cancer and undergoing treatment for the same. Haemodynamicaly stable participants.
Comprehend the commands. Participants with insomnia score >7 according to Insomnia severity index and pain score >4 according to Short Form-McGill Pain Questionnaire. Participants who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Psychiatric illness as diagnosed by psychiatrist.
Any other neurological conditions as diagnosed by surgical oncologist or neurologist.
Red flag from the treating surgeon or physician.
Palliative care or hospice care patients.
Previous exposure to mind body intervention program.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Insomnia severity index, Short Form-McGill Pain Questionnaire-2 |
Baseline and after 7 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
WHO well being index,
Functional assessment of cancer therapy-General |
At baseline and after 7 days of intervention |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
02/03/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study intend to evaluate
the effect of a brief mindfulness
meditation program along with physiotherapy
to manage insomnia and pain in cancer patients and its effect on their
well being and quality of life. The
intervention will be conducted for 3 sessions; for 1 week. During 1st session
fundamental mindfulness skills such as breath awareness, awareness of thoughts
and emotions, body scans, sitting meditation and forgiving meditation will be
given. In the 2nd and 3rd session,
discussion of issues concerning sleep with participant’s experience related to
insomnia and pain will be done. According to their issues the moment to moment
awareness in the participant’s live and utilization of the process associated
with mindfulness throughout the day will be encouraged. In each
session routine physiotherapy protocol of strengthening exercises for the
pelvic floor muscles and transverse abdominis muscles,
stretching exercises for muscles attached to the pelvic girdle, and
diaphragmatic breathing technique will be given before the mindfulness
meditation program. All the outcome measures will be taken at the beginning and at the end of the 1 week protocol. |