| CTRI Number |
CTRI/2024/07/071506 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Marriage on Inner Struggles in Women: Exploring Internalized Misogyny, Self-Silencing and Psychological Distress |
|
Scientific Title of Study
|
Influence of Marriage on the Relationship among Internalized Misogyny, Self-silencing and Psychological Distress in Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dheekshnya S |
| Designation |
PG Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7358654349 |
| Fax |
|
| Email |
dheekshnya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Indu Toby |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482784595 |
| Fax |
|
| Email |
indu.toby@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Indu Toby |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482784595 |
| Fax |
|
| Email |
indu.toby@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions,
Manipal Academy of Health Professions
Manipal, Udupi
Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Dheekshnya S |
| Address |
Department of Clinical Psychology
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal - 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dheekshnya S |
Kasturba Hospital |
Fifth Floor
Department of Clinical Psychology
Smt Sharada Madhav Pai OPD Block
Madhav Nagar
Manipal - 576104
Udupi
KARNATAKA |
7358654349
dheekshnya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Relationship among Internalized Misogyny, Self-silencing and Psychological Distress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria for married women
1 Married women between the ages of 25 to 40 years
2 Women who have working proficiency in English language
3 Women married for more than 3 years
4 Women living with their partner
Inclusion criteria for unmarried women
1 Women aged between 25 and 40 years
2 Women having working proficiency in English language |
|
| ExclusionCriteria |
| Details |
1 Divorced and/or widowed women
2 Women with previous psychiatric conditions and/or undergoing treatment for the past 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Internalized misogyny
Self silencing
Psychological Distress |
As it is an observational study, the outcomes will be measured at the end of the study |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/08/2024 |
| 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="7"
Days="21" |
|
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
|
This study is a cross sectional correlational research aiming to understand the influence of marriage on the relationship among Internalized Misogyny, Self-Silencing and Psychological Distress in women. It will be conducted in the Manipal district of Karnataka, India. The primary outcome is to measure the levels of Internalized misogyny, Self-silencing and Psychological Distress in women using the Internalized Misogyny Scale, The Silencing of the Self Scale and the Kessler Psychological Distress Scale. The total sample size for the study is 50, among which 25 will be unmarried and 25 married women respectively. |