| 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
|
|
|
Primary Sponsor
|
| Name |
PARASHMONI BORAH |
| Address |
LGBRIMH TEZPUR |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| 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
|
|
|
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. |