Effectiveness of a Sexual Health Intervention in Women With Genitourinary Syndrome of Menopause to Improve Their Quality of Life. Multicentre Clinical Trial. Project EXIMe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Main-Quality of life in menopause
研究概览
简要总结
Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid.
详细描述
Genitourinary Syndrome of Menopause is a common condition that increases by four the risk of having a sexual dysfunction, and that affects the quality of life of women who suffer it. Those women with an active sexual life have fewer symptoms associated with this syndrome. Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid. Population: women aged between 45-65 years with Genitourinary Syndrome of Menopause attending to the midwife consultation. N= 250 (125 women in each group) will be included by midwifes in the Primary Health Care consultations in the Community of Madrid. Control group: women will receive the usual assistance.
Experimental group: in addition to the usual assistance, women will receive a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used. Variables: Main-Quality of life in menopause (measured with the Cervantes Short-Form Scale). Secondary- sociodemographic variables, sexual history and variables related to the Genitourinary Syndrome of Menopause. Analysis: by intention-to-treat, comparing the quality of life in menopause scores before/after the intervention in both groups after 0, 1 and 6 months. To explain the factors associated with a higher quality of life, a linear regression model would be fitted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Only primary care midwives know and apply the intervention
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women aged between 45-65 years with Genitourinary Syndrome of Menopause
排除标准
- •women who present pathologies that lead to an alteration of sexual desire
- •women who receive or have received in the last six months treatment that increase the incidence of vaginal atrophy
- •women who receive or have received local hormonal therapy during the last month, systemic hormonal therapy in the last six months, or other systemic treatment for the Genitourinary Syndrome of Menopause
- •women who could not read or write, and not understand the spanish language.
结局指标
主要结局
Main-Quality of life in menopause
时间窗: Change from baseline Quality of life at six months
Main-Quality of life in menopause measured with "Cervantes Short-Form Scale" (20 -100 points)
次要结局
- Urine sediment(Change from baseline at six months)
- Sexual function(Change from baseline at six months)
- vaginal pH(Change from baseline at six months)
- Oxford scale(Change from baseline at six months)