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临床试验/CTRI/2024/05/067572
CTRI/2024/05/067572尚未招募2 期

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 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Marital intimacy

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Marital intimacy

时间窗: At time of enrollment, six weeks after enrollment.

Sexual communication

时间窗: At time of enrollment, six weeks after enrollment.

次要结局

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

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Poulami Chakraborty

AIIMS, New Delhi

研究点 (1)

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