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CTRI Number  CTRI/2022/01/039876 [Registered on: 31/01/2022] Trial Registered Prospectively
Last Modified On: 31/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   a community-based study-Quality life, body image and subjective wellbeing in perimenopausal women  
Scientific Title of Study   Quality of life, body image and subjective wellbeing in perimenopausal women: a community-based study in the urban areas of Tezpur 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SARBANI BORKOTOKY  
Designation  Mphil Scholar  
Affiliation  LGB Regional Institute of Mental Health  
Address  Dept of Psychiatric Social Work , LGB Regional Institute of Mental Health, Tezpur,Assam

Sonitpur
ASSAM
784001
India 
Phone  8638110891  
Fax    
Email  sarbaniborkotoky95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonia P Deuri  
Designation  Hod and Professor , Dept of Psychiatric Social Work  
Affiliation  LGB Regional Institute of Mental Health  
Address  Dept of Psychiatric Social Work , LGB Regional Institute of Mental Health, Tezpur,Assam

Sonitpur
ASSAM
784001
India 
Phone  8638110891  
Fax    
Email  soniadeuri28@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SARBANI BORKOTOKY  
Designation  Mphil Scholar  
Affiliation  LGB Regional Institute of Mental Health  
Address  Dept of Psychiatric Social Work , LGB Regional Institute of Mental Health, Tezpur,Assam


ASSAM
784001
India 
Phone  8638110891  
Fax    
Email  sarbaniborkotoky95@gmail.com  
 
Source of Monetary or Material Support  
Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health  
 
Primary Sponsor  
Name  SARBANI BORKOTOKY 
Address  LGB REGIONAL INSTITUTE OF MENTAL HEALTH,TEZPUR,ASSAM,784001 
Type of Sponsor  Other [ACADEMIC INSTITUTION AND HOSPITAL ] 
 
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 
SARBANI BORKOTOKY   LGB Regional Institute of Mental health , Tezpur   LGB REGIONAL INSTITUTE OF MENTAL HEALTH
Sonitpur
ASSAM 
08638110891

sarbaniborkotoky95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  WOMEN AGED FROM 40 TO 60 YEARS  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  •Women residing in ward no 6 under Tezpur Municipality Ward.
•Women aged between 40-60 years.
•Women who report irregular menstrual cycles within past one year .
•Women who are residing in urban areas of Tezpur.
•Women having primary education.
•Women who are willing to participate in the study
 
 
ExclusionCriteria 
Details  •Women who have experienced an induced menopause, due to several medical conditions such as hysterectomies, ovariectomies, radiation or chemotherapy.
•Women who report severe physical illness , mental illness.
•Women on medications such as anxiolytics, anti-depressants , to avoid treatment –related effects
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The expected outcome from this study is it will help in understanding the quality of life, body image and subjective well-being among perimenopausal women  12 MONTHS  
 
Secondary Outcome  
Outcome  TimePoints 
It will also help in future planning of creating awareness for the holistic well-being of the women.  12 MONTHS  
 
Target Sample Size   Total Sample Size="83"
Sample Size from India="83" 
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)   01/02/2022 
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 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 major transition in the life cycle of women. It is accompanied by complexities and overlapping transitions like biological,  physiological, psychological and social roles. The process takes many years and can vary in the onset, duration and manifestation of  symptoms. This stage can affect the women in various ways which have implications for their mental health. Their quality of life, perceptions of their body and subjective wellbeing can be affected in this transitional stage. My study aims to study the quality of life, body image and subjective wellbeing of women in the perimenopausal stage. To describe the socio-demographic profile of perimenopausal women, To examine the quality of life, body image and subjective well-being of perimenopausal women,To determine the relationship between selected   socio – demographic variables, quality of life, body image and subjective wellbeing among perimenopausal women. This study will help to understand the psychological changes of women in perimenopausal stage and thereby contribute to developing prevention and promotion programs for  women.To the best of my knowledge, this will be one of the few studies conducted in Assam on quality of life, body image and subjective wellbeing of perimenopausal women. - This study will use quantitative approach and will be a descriptive design and will be conducted in urban areas of Tezpur. This study will be conducted using the quantitative approach. Descriptive research   design will be used for the study. Women aged 40-60 years residing in the selected Tezpur Municipality Ward No 6. The setting of the study will be in community i.e selected ward from Tezpur Municipality Ward .For the study, ward no 6  under Tezpur Municipality Ward has been selected through purposive sampling. Using simple random sampling, households will be selected and all women in the aged 40-60 years will be screened and tools will be administered for those meeting the inclusion criteria.  In this study, the sampling frame is the voter list of women population of the age 40-60 years. Sampling unit will be women aged 40-60 years and above living in the selected ward under Tezpur Municipality. Total population of women aged from 40-60 years under Ward 6 of Tezpur Municipality Board is 567. So, the sample size will be 83 keeping the margin of error at 10% .The study will be undertaken after obtaining approval from the scientific and ethical committee

 
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