| CTRI Number |
CTRI/2025/10/096550 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Menopause on Physical and Mental Health of females in their pre, peri and postmenopause stage. |
|
Scientific Title of Study
|
Impact of Menopausal Transition and Postmenopause on Physical and Mental Health and
Its Association with the Quality of Life: A Cross-Sectional Study. |
| 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 Anu Arora |
| Designation |
Professor |
| Affiliation |
School of Physiotherapy, D.Y.Patil Deemed to be University, Nerul |
| Address |
SCHOOL OF PHYSIOTHERAPY DY PATIL DEEMED TO BE UNIVERSITY SECTOR 5 NERUL NAVI MUMBAI
Thane MAHARASHTRA 400706 India |
| Phone |
08452842895 |
| Fax |
|
| Email |
anu.arora@dypatil.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anu Arora |
| Designation |
Professor |
| Affiliation |
School of Physiotherapy, D.Y.Patil Deemed to be University, Nerul |
| Address |
SCHOOL OF PHYSIOTHERAPY DY PATIL DEEMED TO BE UNIVERSITY SECTOR 5 NERUL NAVI MUMBAI
Thane MAHARASHTRA 400706 India |
| Phone |
08452842895 |
| Fax |
|
| Email |
anu.arora@dypatil.edu |
|
Details of Contact Person Public Query
|
| Name |
Radhika Bidkar |
| Designation |
Physiotherapist |
| Affiliation |
School of Physiotherapy, D.Y.Patil Deemed to be University, Nerul |
| Address |
SCHOOL OF PHYSIOTHERAPY, D.Y.PATIL DEEMED TO BE UNIVERSITY, SECTOR 5 NERUL NAVI MUMBAI, INDIA
Thane MAHARASHTRA 400706 India |
| Phone |
9867980605 |
| Fax |
|
| Email |
radhasbidkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy |
| Address |
School of Physiotherapy, 6th Floor, D.Y.Patil Medical College , Sector 5 Nerul |
| Type of Sponsor |
Private medical college |
|
|
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 ANU ARORA |
D.Y Patil Hospital & Research Centre |
OPD No 27, D.Y.patil Hospital and research Centre Sector 5 Nerul Navi Mumbai Thane MAHARASHTRA |
08452842895
anu.arora@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research D. Y. Patil Deemed to be University School of Medicine Navi-Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pre, Peri, Post Menopause |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Women aged 40-55 years.
2.Pre, Perimenopausal and postmenopausal women as defined by STRAW+10 criteria.
3.Willingness to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1.Women who have undergone HRT/ surgical menopause in last 6 months
2.History of psychiatric illness.
3.Women with major medical conditions (e.g., cancer, stroke) affecting QOL.
4.Women who are unable to complete the questionnaires. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Menopause rating Scale: Three independent dimensions are assessed:
Psychological, somato-vegetative, and urogenital sub-scale.
2.Participation Scale (Short Version)
3.Menopause Quality of Life
4.IPAQ (International Physical Activity Questionnaire) |
Only one time assessment using the scales |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
08/11/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Menopause is permanent cessation of menses for a year due to loss of ovarian follicular activity due to estrogen deficiency and not associated to any pathology. Premenopause is a period of regular or irregular menses before menopause or perimenopause when the female is still capable of reproduction. Perimenopause is a period from immediately prior to menopause (when biological, endocrinological & clinical features begin) to at least one year after menopause. Postmenopause is the period after the menopause. Menopause transition is a period starting from first irregular menses or skipped menstrual period to final menstrual period. Menopause Transition is associated with a lot of changes: Hormonal changes, particularly the decline in estrogen, are linked to symptoms such as hot flashes, fatigue, musculoskeletal pain, anxiety, depression, and sleep disturbances, and other changes like reproductive status, appearance, bodily functions, expectations, social circumstances, & relationships. These, in turn, can affect a woman’s quality of life (QOL) The menopause transition is roughly divided into 2 phases, which are initially based on menstrual patterns. The early transition is characterized by a small increase in prevalence of common menstrual symptoms, but perturbation of cycles is minimal, with women having at least 1 menstrual cycle within past 3 months. A woman has entered the early menopausal transition when she experiences a >7days difference, when the interval of amenorrhea > 60 days she has entered the late menopause transition & when 12 months have passed since a woman’s last menses is the early postmenopause .Physical Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity [4]. Postmenopausal musculoskeletal pain is generally associated with reduction of the ovarian function, where there is decline in the production of mainly estrogen hormone. Estrogen deficiency leads to increased cartilage wear and tear and joint surface erosion, reduction in bone mineral density, loss of muscle mass and strength, decrease in the collagen content of connective tissues which further leads to impairment in the muscle performance and functional capacity.The current study seeks to evaluate the physical and mental health status of women during the menopausal transition and postmenopause and explore its association with quality of life using validated assessment tools. The study will also examine factors like physical activity levels and body mass index (BMI) that may modify these associations. Aim of the study: To assess the physical and mental health status of women during the menopausal transition and postmenopause and determine its association with quality of life. |