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| Name | Class |
|---|---|
| Fundación de Innovación e Investigación Biomédica de Atención Primaria-Madrid | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXIMe intervention | Experimental | 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. |
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| Usual care | Active Comparator | Usual care according to available protocols applicable to the women and the health service standardized portfolio |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complex intervention in sexual health | Other | EXIMe is 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Main-Quality of life in menopause | Main-Quality of life in menopause measured with "Cervantes Short-Form Scale" (20 -100 points) | Change from baseline Quality of life at six months |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual function | Sexual function: measured with Questionnaire "Health and female sexual dysfunction in primary care" | Change from baseline at six months |
| vaginal pH | vaginal pH |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucia Martinez-Villarejo, Midwife | Gerencia de Atención Primaria, Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gerencia de Atención Primaria, Madrid | Madrid | 28035 | Spain |
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| ID | Term |
|---|---|
| D000074384 | Sexual Health |
| ID | Term |
|---|---|
| D006262 | Health |
| D011154 | Population Characteristics |
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Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid
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Only primary care midwives know and apply the intervention
|
| Usual care | Other | According to available protocols applicable to the patient and the health service standardized portfolio |
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| Change from baseline at six months |
| Oxford scale | Oxford scale: pelvic floor muscle response | Change from baseline at six months |
| Urine sediment | Urine sediment | Change from baseline at six months |