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"Menopause Experiences in Cultural and Intercultural Contexts" (VIMEC-IC)

12 de junio de 2026 actualizado por: Institut Investigacio Sanitaria Pere Virgili

"Menopause Experiences in Intercultural Contexts and Healthcare Professionals: A Mixed- Methods Study Protocol in Community Settings"

The climacteric period involves physical, hormonal, and emotional changes that can impact a woman's quality of life. This mixed-methods study aims to explore the perceptions and experiences of women during menopause and the influence of cultural ethnicity on their quality of life in Primary Care centers in Tarragona. The research includes a quantitative phase to assess healthcare professionals' knowledge via electronic surveys and a qualitative phase using individual interviews with women from diverse backgrounds. The goal is to identify specific needs to adapt community nursing interventions and improve health promotion and equity during the climacteric stage.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

This study employs a mixed-methods approach to provide a comprehensive understanding of the climacteric process in the health area of Tarragona. The research is divided into two distinct but complementary phases:

  1. Quantitative Phase (Cross-sectional Descriptive Study):

    The objective is to evaluate the level of knowledge and the attitudes of healthcare professionals (nurses and physicians) regarding menopause management.

    Data Collection: An ad hoc questionnaire will be distributed electronically through the corporate email systems of the Primary Care centers (ICS).

    Variables: Sociodemographic data, professional profile, and specific knowledge scores on menopause, Mediterranean diet, and physical activity recommendations.

    Analysis: Descriptive and inferential statistics will be performed using IBM SPSS Statistics.

  2. Qualitative Phase (Phenomenological Approach):

The objective is to explore the lived experiences, perceptions, and cultural influences of women in the climacteric stage.

Data Collection: Semi-structured individual interviews will be conducted with women from diverse sociocultural and ethnic backgrounds to ensure maximum variation.

Sampling: Purposeful sampling will be used until data saturation is reached.

Analysis: All interviews will be transcribed verbatim and analyzed using thematic analysis with the support of Atlas.ti software.

Ethics and Integration:

The study follows the Declaration of Helsinki and has been approved by the Ethics Committee (IDIAP Jordi Gol). Data from both phases will be integrated to identify specific gaps in clinical practice and the real-world needs of women, aiming to design better community nursing interventions.

Tipo de estudio

De observación

Inscripción (Estimado)

25

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Rocío Legaz Pagán, PhD Student, RN, BcS
  • Número de teléfono: 0034 +34646057662
  • Correo electrónico: rlegazpagan39@gmail.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Tarragona, España
        • Reclutamiento
        • Institut Català de la Salut (ICS) - Camp de Tarragona.
        • Contacto:
        • Contacto:
          • Rocío Legaz Pagán, RN, BcS, PhD Student
          • Número de teléfono: 0034 646057662
          • Correo electrónico: rlegazpagan39@gmail.com
        • Investigador principal:
          • Rocío Legaz Pagán, RN, BcS, PhD Student
        • Sub-Investigador:
          • Marina Gómez de Quero Cordoba, RN, MSN, PhD
        • Sub-Investigador:
          • Rosa Raventós Torner, RN, MSN, PhD
        • Sub-Investigador:
          • Cristina Rey Reñones, RN, MSN, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

The study population consists of two main groups located in the Tarragona healthcare area:

Healthcare Professionals: Nurses and physicians working in Primary Care centers (Institut Català de la Salut) who provide care to women during the climacteric stage.

Women in the Climacteric Stage: Women aged 40 to 65 years from diverse sociocultural and ethnic backgrounds who are users of the Primary Care centers in the same geographical area.

The sample will be drawn from urban and rural health centers to ensure a representative professional perspective and a diverse range of lived experiences from the women interviewed.

Descripción

Inclusion Criteria:

For professionals:

  • Healthcare professional aged 18 years or older.
  • Currently working in the Primary Care setting.
  • Provide care or work with women in the climateric stage.
  • Agreement to participate and completion of the anonymous survey after providing informed consent.

For Women (Qualitative Phase):

  • Women aged 40 to 65 years.
  • Currently in the climacteric stage (perimenopause or postmenopause).
  • Belonging to diverse sociocultural or ethnic backgrounds.
  • Ability to communicate and provide informed consent for the individual interview.

Exclusion Criteria:

For porfessionals:

*Refusal to participate in the study or incomplete electronic survey.

For Women (Qualitative Phase):

  • Inability to understand the study's language (Spanish or Catalan).
  • Cognitive impairment that prevents the participant from providing informed consent or participating in the interview/survey.
  • Refusal to participate in the study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Healthcare Professionals
Primary care nurses and physicians working in the health centers of Tarragona (ICS). This group will participate in the quantitative phase by completing an online survey about their knowledge and attitudes toward menopause.

For Professionals: An electronic questionnaire to assess knowledge and attitudes toward menopause.

For Women: A qualitative semi-structured interview to explore their perceptions and lived experiences during the climacteric stage.

Women in Climacteric Stage
Women aged between 40 and 65 years from diverse sociocultural and ethnic backgrounds. This group will participate in the qualitative phase through individual semi-structured interviews to explore their experiences and quality of life.

For Professionals: An electronic questionnaire to assess knowledge and attitudes toward menopause.

For Women: A qualitative semi-structured interview to explore their perceptions and lived experiences during the climacteric stage.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Perceptions and Lived Experiences of Women in the Climacteric Stage.
Periodo de tiempo: Baseline.
Exploration of the subjective experiences, cultural influences, and quality of life through thematic analysis of semi-structured interviews.
Baseline.
Level of Knowledge and Attitudes of Healthcare Professionals Regarding Menopause.
Periodo de tiempo: Baseline at the time of survey completion.
Evaluation of knowledge scores and professional attitudes towards menopause management through an ad hoc electronic questionnaire. The questionnaire provides a total score ranging from 0 to10, where 0 indicates the lowest level of knowledge and poorest attitude, and 10 indicates the highest level of knowledge and most positive attitude towards menopause management.
Baseline at the time of survey completion.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Rosa Raventós Torner, RN, MSN, PhD, Universidad Rovira i Virgili
  • Director de estudio: Cristina Rey Reñones, RN, MSN, PhD, Universidad Rovira Y Virgili
  • Investigador principal: Rocío Legaz Pagán, PhD Student, RN, MSc, Universidad Rovira Y Virgili
  • Director de estudio: Marina Gómez de Quero Cordoba, RN, MSN, PhD, Universidad Rovira Y Virgili

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

27 de abril de 2026

Finalización primaria (Estimado)

22 de abril de 2028

Finalización del estudio (Estimado)

22 de abril de 2030

Fechas de registro del estudio

Enviado por primera vez

29 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

"Individual participant data will not be shared to protect the confidentiality and anonymity of the participants, in accordance with the informed consent and Spanish data protection laws (LOPDGDD 3/2018)."

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Condiciones MeSH válidas

Ensayos clínicos sobre Survey and Semi-structured Interview

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