Multicentre Clinical Trial. Project EXIMe
Condition: Menopause
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Complex intervention in sexual health; Usual care
Intervention type(s): Other; Other
Intervention description(s): 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.; According to available protocols applicable to the patient and the health service standardized portfolio
Other intervention name(s): Usual care; Women will receive the usual assistance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary health care