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Clinical Trials/CTRI/2024/05/067572
CTRI/2024/05/067572Not yet recruitingPhase 2

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

AIIMS New Delhi1 site in 1 country60 target enrollmentStarted: August 1, 2024Last updated:
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Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Marital intimacy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
19.00 Year(s) to 59.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •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).

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Marital intimacy

Time Frame: At time of enrollment, six weeks after enrollment.

Sexual communication

Time Frame: At time of enrollment, six weeks after enrollment.

Secondary Outcomes

  • Sexual satisfaction among partners(Barriers of communication among partners)

Investigators

Sponsor
AIIMS New Delhi
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Poulami Chakraborty

AIIMS, New Delhi

Study Sites (1)

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