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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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