| CTRI Number |
CTRI/2023/05/052292 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of emotional intimacy in embodied gender norms and sexual difficulties in women who have gone through breast cancer surgery |
|
Scientific Title of Study
|
Role of emotional intimacy in gender role socialisation and sexual distress in breast conserving and mastectomy groups |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arya Mohan |
| Designation |
MPhil Clinical Psychology Trainee |
| 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
Udupi
KARNATAKA
576104
India |
| Phone |
9164860090 |
| Fax |
|
| Email |
arya.mohan1@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sebastian Padickaparambil |
| Designation |
Additional Professor and Head of Department of Clinical Psychology |
| 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
Udupi
KARNATAKA
576104
India |
| Phone |
9482916960 |
| Fax |
|
| Email |
sebastian.p@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sebastian Padickaparambil |
| Designation |
Additional Professor and Head of Department of Clinical Psychology |
| 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
KARNATAKA
576104
India |
| Phone |
9482916960 |
| Fax |
|
| Email |
sebastian.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Udupi, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Arya Mohan |
| Address |
Department of Clinical Psychology,Manipal College of Health Professions, Manipal Academy of Higher Education,Manipal, Udupi,Karntaka - 576104 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Arya Mohan |
Kasturba Hospital |
Breast Clinic, OPD B, Surgery unit 6, Department of General Surgery, Manipal
Udupi
KARNATAKA |
9164860090
arya.mohan1@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women who underwent Breast Conserving Surgery
Women who underwent breast conserving surgery and has completed the duration of minimum 3 months post the procedure. Age range 18 – 50, Married women, Literate – Read and understand Kannada/ English
Women who underwent Mastectomy
Women who underwent Mastectomy and has completed the duration of minimum 3 months post the procedure, Age range 18 – 50, Married women, Literate – Read and understand Kannada/English
|
|
| ExclusionCriteria |
| Details |
Women who underwent Breast Conserving Surgery
1.Previous history of any psychiatric illness/medications
2.Presence of any hearing or visual impairment.
3.Previous diagnosis of sexual difficulties.
Women who underwent Mastectomy
•Previous history of any psychiatric illness/medications
•Presence of any hearing or visual impairment.
•Previous diagnosis of sexual difficulties
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To investigate if emotional intimacy, gender role socialization and sexual distress have a role in Breast Conserving Surgery and Mastectomy.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the differences between Breast Conserving Surgery and Mastectomy. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
08/05/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is an observational study aimed to investigate the Role of Emotional Intimacy in Gender Role Socialization and Sexual Distress in Breast Conserving Surgery and Mastectomy group. Objectives of the study is to investigate if emotional intimacy, gender role socialization and sexual distress have a role in Breast Conserving Surgery and Mastectomy and to compare the differences between Breast Conserving Surgery and Mastectomy.The results of the study can help us design interventions aimed at reducing sexual distress and improving intimacy can be designed.The importance of acknowledging sexual changes and their related components can be further analyzed and incorporated as part of holistic management for breast cancer survivors.
|