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CTRI Number  CTRI/2025/07/091192 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   Development and testing the efficacy of Midlife Crisis and Menopausal Quality of Life (MC-MQoL) Care Module for menopausal women: A Community-based Study 
Scientific Title of Study   Development and testing the efficacy of Midlife Crisis and Menopausal Quality of Life (MC-MQoL) Care Module for menopausal women: A Community-based 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  PARASHMONI BORAH 
Designation  PhD SCHOLAR 
Affiliation  LGBRIMH 
Address  LGBRIMH TEZPUR

Sonitpur
ASSAM
784001
India 
Phone  8133804238  
Fax    
Email  pborahh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PARASHMONI BORAH 
Designation  PhD SCHOLAR 
Affiliation  LGBRIMH 
Address  LGBRIMH TEZPUR

Sonitpur
ASSAM
784001
India 
Phone  8133804238  
Fax    
Email  pborahh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PARASHMONI BORAH 
Designation  PhD SCHOLAR 
Affiliation  LGBRIMH 
Address  LGBRIMH TEZPUR

Sonitpur
ASSAM
784001
India 
Phone  8133804238  
Fax    
Email  pborahh@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  PARASHMONI BORAH 
Address  LGBRIMH TEZPUR 
Type of Sponsor  Other [Self funded] 
 
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 
Parashmoni Borah  LGBRIMH  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health PO Tezpur, Sonitpur PIN 784001
Sonitpur
ASSAM 
8133804238

pborahh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee LGBRIMH Tezpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Menopause 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Midlife Crisis and Menopausal Quality of Life (MC-MQoL) Care Module  Midlife Crisis and Menopausal Quality of Life (MC-MQoL) Care Module will be prepared by the researcher from extensive review of literature, input from FGD and own clinical expertise. The module will be implemented by the researcher through face-to-face interaction utilizing both individual and group format. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Day(s)
Age To  55.00 Day(s)
Gender  Female 
Details  1.Menopausal women from selected area of Sonitpur District, Assam.
2.Women who have ceased menstruation for at least 12 consecutive months but not more than 5 years.
3.Menopausal women who will score above the median on the Mid-Life Transition Questionnaire (MTQ) and whose MENQOL mean scores indicate mild to severe decline in quality of life .
 
 
ExclusionCriteria 
Details  1.Women who experienced menopause before the age of 40 (due to conditions like premature ovarian insufficiency), as their experience may differ from typical menopausal transitions.
2.Women who are currently on hormone replacement therapy and other psychosocial interventions.
3.Menopausal women who are severely physically ill.
4.Women with surgically induced menopause.
5.Women who are on psychotropic medication.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Menopausal Quality of Life (MC-MQoL) Care Module will be reducing midlife crisis and enhanced quality of life for menopausal women.  1month and 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes of the study include identification of midlife crisis, coping strategies of menopausal women to reduce midlife crisis and maintaining quality of life  1month 
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   08/09/2025 
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="2"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The life span of human being is continuous process of developmental changes in various dimension like biological, psychological and social. Each stage of life brings unique challenges, adjustments, and opportunities for growth. According to Erikson, midlife is the stage where an individual seeks to find purpose through productivity, caregiving, and contribution to the next generation. Whereas women go through menopause at this stage of life which marked by physiological symptoms, somatic symptoms, psychological symptoms due to the hormonal shifts. The menopausal phase and midlife coincide which increases the challenges of women’s life and not meeting the psychosocial need may lead to midlife crisis. Midlife crisis of women may involve feelings of isolation, inferiority, and pressure to remain youthful, often worsened by societal stigma around aging especially in Indian culture. These changes may deteriorated quality of life of women and their wellbeing. Despite the growing recognition of the challenges faced by menopausal women with midlife crisis, limited researches have been observed which focuses on psychosocial intervention to meet the needs of menopausal transition and midlife crisis. A comprehensive psychosocial intervention designed to meet the needs arises from these challenges may enhance the quality of life of menopausal women.  Therefore, researcher aims to develop an intervention module and test the efficacy of the module to fill this gap and offer the healthcare providers with more diverse tools for managing midlife crisis and quality of life during menopause. 

The proposed research will follow a mixed method approach comprises of two phases. The 1st phase will be conducted with qualitative approach where narrative literature review and phenomenological Research design will be used to develop the “MC-MQoL Care Module” (Midlife Crisis and Menopausal Quality of Life Care Module). Existing literature related to the content and input from the participants through focused group discussions will be used and the nursing intervention module will be prepared considering the cultural suitability. Prepared content will be validated by the expert panel of mental health professionals. The recommendations and suggestions will be incorporated and the validity index will be ensured to finalize the module. The 2nd phase of the study will be conducted with quantitative approach by implementing the module to find out its efficacy. The research design in this phase will be pre-experimental one group pre-test post-test design. The sample will be the menopausal women in the selected area of Sonitpur District, Assam which will be selected through purposive sampling technique. Data will be collected for dependent variable midlife crisis and quality of life of menopausal women by using Socio-demographic Proforma, Mid-Life Transition Questionnaire (MTQ) and MENQOL (Menopause-Specific Quality of Life) questionnaire. “MC-MQoL Care Module” will be implemented followed by the pre-test. Post test will be done twice i.e. after one month of intervention and after three months of intervention. An informed consent will be taken from each participant and confidentiality and anonymity will be maintained throughout the study period. Appropriate statistical analysis will be done to find out the efficacy of the developed module by using SPSS.

 Midlife and menopause are complex life transition that involves both physical and emotional aspects. Developing comprehensive psychosocial intervention tailored to midlife crisis and quality of life of menopausal women could guide healthcare providers with more diverse tools leading to evidence-based care.

 
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