| CTRI Number |
CTRI/2017/07/009071 [Registered on: 18/07/2017] Trial Registered Prospectively |
| Last Modified On: |
14/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Enhancement of quality of life among menopausal women |
|
Scientific Title of Study
|
Multi component life style strategies on knowledge, menopausal symptoms, lifestyle behavior and biological parameters among women. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Timi Thomas |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Usha Institute of Nursing SciencesDr. Neetha Kamath |
| Address |
Department of Obsterics and gynaecological Nursing
Nitte Usha Institute of Nursing Sciences
Paneer, Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8123765753 |
| Fax |
08242203163 |
| Email |
timjith@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetha Kamath |
| Designation |
Associate Professor |
| Affiliation |
Nitte Usha Institute of Nursing SciencesDr. Neetha Kamath |
| Address |
Department of Community Health Nursing
Nitte Usha Institute of Nursing Sciences
Paneer, Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845472309 |
| Fax |
08242203163 |
| Email |
neetha.jayavanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna Kumar Shetty |
| Designation |
Professor |
| Affiliation |
KSHEMA |
| Address |
Department of Obsterics and gynaecological Nursing
K.S Hegde Charitable Hospital
Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886757440 |
| Fax |
08242203163 |
| Email |
prasanna.kumar.shetty@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self Funding |
| Address |
Assistant Professor
Department of OBG nursing
Nitte Usha Institute of Nursing Sciences
Paneer
Deralakatte
|
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Timi Thomas |
Nitte University |
Kotekar Primary Health Center
Kotekar grama panchayath,Mangalore Taluk
Dakshina Kannada
KARNATAKA |
8123765753
08242203163
timjith@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
menopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness Based Stress Reduction |
In this study MBSR refers to the exercises viz. mindfulness meditation, body scan meditation and Hatha yoga postures. These exercises are helpful in reducing anxiety, stress, depression, pain, and weight management. MBSR will be practiced under supervision for a duration of three months, an hour per day. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
48.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.The study participants shall be aged between 48- 55 years. |
|
| ExclusionCriteria |
| Details |
1.The participants who were already practicing meditation and yoga regularly
2.The participants with surgical menopause
3.The participants receiving any kind of hormone replacement therapy
4.The participants receiving Anti coagulant therapy
5.Participants with mental illness like anxiety disorder, depression, schizophrenia and mood disorders
6.Participants with diabetes, hypertension, cardiac diseases and IVDP.
7.The participants receiving any kind of chemo or radiation therapy.
8.Participants with history of cancer in the reproductive organs like breast, cervix, uterus, vulva, endometrium and ovary.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be significant difference in knowledge, menopausal symptoms, lifestyle behavior and biological parameters before and after the treatment in group one.
There will be significant difference in knowledge, menopausal symptoms, lifestyle behavior and biological parameters after the treatment in group one and two.
|
2 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
There will be significant difference in pre experimental knowledge, menopausal symptoms, lifestyle behavior and biological parameters scores.
There will be significant difference in knowledge, menopausal symptoms, lifestyle behavior and biological parameters after the treatment.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="171"
Sample Size from India="171"
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)
|
18/10/2017 |
| 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="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The primary investigator had written a concept paper on Women’s natural transition; Nature supports in climacteric life and submitted to Indian Jornal of Nursing Education. THE authoe received a mail frim the editor that the article got accepted for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Considering the limitation of hormone replacement therapy, the health professionals are searching for different ways to manage menopause to minimize discomfort and inconvenience during menopausal transition, so as to improve the quality of life among menopausal women. The present need is to explore new options for the management of menopausal symptoms in the form of non hormonal drug therapy and non pharmacological measures. The current recommendations are diet, regular exercise, change in lifestyle, yoga, therapeutic massage and other stress reducing measures. Many treatments are available to date for the management of menopause symptoms. Among all the available treatments , dietary supplement, mind body techniques and yoga could play an effective role in the management of menopausal symptoms due to less cost, time and effort. |