| CTRI Number |
CTRI/2023/06/053911 [Registered on: 15/06/2023] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Yoga on Menopausal Symptoms and the Quality of Life
of Women
|
|
Scientific Title of Study
|
Effectiveness of Yoga on Menopausal Symptoms and the Quality of Life of women in a selected area of Mangaluru. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Jyothis Baby |
| Designation |
M.Sc. NURSING student |
| Affiliation |
Father muller college of nursing |
| Address |
FATHER MULLER COLLEGE OF NURSING
Kankanady,
MANGALURU- 575002.
Karnataka,India.
FATHER MULLER COLLEGE OF NURSING
MANGALURU- 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8951105146 |
| Fax |
|
| Email |
jyothisbaby123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Jyothis Baby |
| Designation |
M.Sc. NURSING student |
| Affiliation |
Father muller college of nursing |
| Address |
plathottam house ,
chembanchery,Balal,
Kasargod
KERALA
FATHER MULLER COLLEGE OF NURSING
MANGALURU- 575002
Dakshina Kannada
KARNATAKA
671533
India |
| Phone |
8951105146 |
| Fax |
|
| Email |
jyothisbaby123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Jyothis Baby |
| Designation |
M.Sc. NURSING student |
| Affiliation |
Father muller college of nursing |
| Address |
plathottam house ,
chembanchery,Balal,
Kasargod
KERALA
FATHER MULLER COLLEGE OF NURSING
MANGALURU- 575002
Dakshina Kannada
KARNATAKA
671533
India |
| Phone |
8951105146 |
| Fax |
|
| Email |
jyothisbaby123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Spandhana Trust, Jeppu.Mangaluru,Karnataka 575002
India |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Ms Pramila DSouza |
Father Muller Medical College Hospital |
VV85
Department of Obstetric and Gynecological Nursing
Father Mullers Road
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA |
9341889198
pramiladsouza@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Ethical 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 |
Yoga |
Effectiveness of Yoga on Menopausal symptoms and quality of life. The total duration of intervention is 2 months. |
| Comparator Agent |
Yoga |
Providing yoga to menopausal women. The total duration of intervention is 2 months. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women of menopausal symptoms with mild ,moderate, and severe categories based on the menopausal rating scale. |
|
| ExclusionCriteria |
| Details |
1. Women who have undergone abdominal surgery for the past one year
2. Women with severe musculoskeletal problems.
3. Women with acute inflammatory diseases, intestinal obstruction, hernia and high blood pressure.
4. Women diagnosed with mental illness.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life of Women |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce menopausal symptoms |
2 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/06/2023 |
| 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 Applicable |
| 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
|
Menopause is a biological occurrence in the process of aging in every woman. The term Menopause comes from the old Greek phrase ‘menopause’ (meno means month and pause means stop), which means ‘cessation of monthly bleeding.’ Most common among them are appearance of hot flashes, vaginal dryness, weakening of the bladder muscles, which leads to urine leakage when sneezing, coughing, laughing, or running, lack of sleep, lack of energy, and memory problems and in some cases due to the loss of estrogen that leads in the reducing bone density which could cause osteoporosis and heart disease, putting on weight, the fluctuation of blood pressure, and diabetes are a few degenerative process of aging. The yoga that aims to improve the balance of body and mind and increase the quality of life among the individuals who regularly practice the yoga (asanas). These asanas are practiced as a physical exercise in the rhythmic postures, the controlling of inhalation and exhalation of breathing technique (pranayama) and contemplative form of meditation (dhyana). These yoga exercises are employed as healing means to achieve positive health outcomes and manage the physical and psychological pain and through that treat some of the diseases. There is large number of women who find it difficult to overcome most of the symptoms of Menopause. Living with such symptoms leads to reduced self-esteem and self-image among women. The practice of yoga as exercise and meditation could be used to overcome some of these symptoms. These exercises may provide a source of overcoming some of the symptoms and that would enhance self-esteem and self-image. The study would also focus on simple yogic practices which help people to forget the psychological and social pressure and concentrate on themselves. That in the course of the time would reduce anxiety and depression. |