| CTRI Number |
CTRI/2024/10/076051 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing body surveillance and sexual satisfaction among heterosexual, lesbian and bisexual women |
|
Scientific Title of Study
|
A comparative study on body surveillance and
sexual satisfaction among heterosexual
lesbian and bisexual 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 |
Ruth Joseph Vaidyan |
| Designation |
PG Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09446530985 |
| Fax |
|
| Email |
ruth1.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Indu Toby |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, MCHP,MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09482784595 |
| Fax |
|
| Email |
indu.toby@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Kulkarni |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, MCHP,MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900038031 |
| Fax |
|
| Email |
sweta.kulkarni@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, MAHE,Manipal,Karnataka 576104 India |
|
|
Primary Sponsor
|
| Name |
Ruth Joseph Vaidyan |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, MAHE, Manipal, Karnataka 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 |
| Ruth Joseph Vaidyan |
Kasturba Hospital |
Fifth floor Department of clinical psychology smt Sharada Madhav Pai OPD block Manipal 576104 Udupi Karnataka
Udupi
KARNATAKA |
9446530985
ruthjosephvaidyan@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 |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Females (Assigned female at birth) â— In a stable sexual relationship with a single partner over the last 6 months â— Unmarried Heterosexual women and lesbian, bisexual, and other queer identifying women |
|
| ExclusionCriteria |
| Details |
Individuals with history of sexual dysfunctions, mood disorders, anxiety disorders and eating disorders and diagnosed with psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| . To compare heterosexual, lesbian and bisexual women on body surveillance and sexual satisfaction using Body surveillance subscale - Objectified Body Consciousness Scale (OBCS) and Ego subscale of the New Sexual Satisfaction scale |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To examine the relationship between body surveillance and sexual satisfaction among heterosexual, lesbian and bisexual women.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
15/11/2024 |
| 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="9"
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
|
Aim : To compare heterosexual, lesbian and bisexual women on body surveillance and sexual satisfaction Primary Objectives: To compare heterosexual, lesbian and bisexual women on body surveillance and sexual satisfaction. Secondary Objectives: To examine the relationship between body surveillance and sexual satisfaction among heterosexual, lesbian and bisexual women. The study duration is from March 2024 to March 2025 |