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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
WOMEN AGED FROM 40 TO 60 YEARS |
|
Intervention / Comparator Agent
|
|
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 |