| CTRI Number |
CTRI/2024/05/067572 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Couple-based intimacy enhancement intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Couple therapy to improve marital intimacy and sexual communication among partners |
|
Scientific Title of Study
|
A study to assess effectiveness of couple-based intimacy enhancement intervention to improve marital intimacy and sexual communication among partners of carcinoma breast patients in selected tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poulami Chakraborty |
| Designation |
Msc Nursing Student |
| Affiliation |
AIIMS, New Delhi |
| Address |
Porta cabin-1, Department-COllege of Nursing, AIIMS, New Delhi, Ansari Nagar
South West
DELHI
110029
India |
| Phone |
8334885318 |
| Fax |
|
| Email |
cpoulami30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poulami Chakraborty |
| Designation |
Msc Nursing Student |
| Affiliation |
AIIMS, New Delhi |
| Address |
Porta cabin-1, Department-COllege of Nursing, AIIMS, New Delhi, Ansari Nagar
South West
DELHI
110029
India |
| Phone |
8334885318 |
| Fax |
|
| Email |
cpoulami30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashi Mawar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room-2, Department: College of Nursing, AIIMS, New Delhi, Ansari Nagar
South West
DELHI
110029
India |
| Phone |
8800228317 |
| Fax |
|
| Email |
drshashimawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Surgery Block, Department of Surgical Discipline, AIIMS, 85, Gautam Nagar Rd, Gautam Nagar, New Delhi, India, Pin: 110049 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
College of Nursing, AIIMS, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Ankita Singh |
Surgery Block, AIIMS, New Delhi |
Room 17, Breast Cancer clinic, ground floor, Department of Surgical Disciplines
New Delhi
DELHI |
9968633853
ankitasingh05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Couple based intimacy enhancement intervention |
A brief couple based counseling of one hour will be provided to both the partners. It will be provided two times at an interval of one week.
It will contain four components-brief about the disease, changes that the patient may come across, methods of improving sexual communication, and improving marital intimacy through open communication |
| Comparator Agent |
Standard care |
It will contain the routine care that patients receive when they come for follow-up in the OPD |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years and less than 60 years
Patients who have undergone surgery—Breast Conservation Surgery or Modified Radical Mastectomy.
In a stable relationship (living with intimate partner for more than or equal to 6 months).
|
|
| ExclusionCriteria |
| Details |
Patients who are not consenting
Divorced/widowed/separated
ECOG performance score more than 2
Cognitive/psychiatric disturbances
Already taking couple therapy
Pregnant
Language barrier/hearing impairment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Marital intimacy
Sexual communication |
At time of enrollment, six weeks after enrollment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sexual satisfaction among partners
Barriers of communication among partners |
At time of enrollment, six weeks after enrollment. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="6"
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
|
This study is an experimental study with the aim of assessing the effectiveness of couple-based intimacy enhancement intervention in improving marital intimacy and communication between partners Carcinoma breast
patients. 1. Hypothesis of this study are: H1: There will be a significant difference in the marital intimacy
between the experimental and control group among Carcinoma breast patients
after giving the couple-based intimacy enhancement intervention as assessed by
Female Sexual Function Index and Personal Assessment of Intimacy in
Relationships at p<0.05 level of significance.
H2: There will be a
significant difference in the sexual communication between partners between the
experimental and control group among Carcinoma breast patients after giving the
couple-based intimacy enhancement intervention as assessed by Dyadic Sexual
Communication Scale at p<0.05 level of significance
|