- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07648680
"Menopause Experiences in Cultural and Intercultural Contexts" (VIMEC-IC)
"Menopause Experiences in Intercultural Contexts and Healthcare Professionals: A Mixed- Methods Study Protocol in Community Settings"
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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:
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.
- 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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Rocío Legaz Pagán, PhD Student, RN, BcS
- Número de telefone: 0034 +34646057662
- E-mail: rlegazpagan39@gmail.com
Estude backup de contato
- Nome: Marina Gómez de Quero Cordoba, RN, MSN, PhD
- E-mail: marina.gomezdequero@urv.cat
Locais de estudo
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-
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Tarragona, Espanha
- Recrutamento
- Institut Català de la Salut (ICS) - Camp de Tarragona.
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Contato:
- Marina Gómez de Quero Cordoba, RN, MSN, PhD
- E-mail: marina.gomezdequero@urv.cat
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Contato:
- Rocío Legaz Pagán, RN, BcS, PhD Student
- Número de telefone: 0034 646057662
- E-mail: rlegazpagan39@gmail.com
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Investigador principal:
- Rocío Legaz Pagán, RN, BcS, PhD Student
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Subinvestigador:
- Marina Gómez de Quero Cordoba, RN, MSN, PhD
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Subinvestigador:
- Rosa Raventós Torner, RN, MSN, PhD
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Subinvestigador:
- Cristina Rey Reñones, RN, MSN, PhD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Perceptions and Lived Experiences of Women in the Climacteric Stage.
Prazo: Baseline.
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Exploration of the subjective experiences, cultural influences, and quality of life through thematic analysis of semi-structured interviews.
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Baseline.
|
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Level of Knowledge and Attitudes of Healthcare Professionals Regarding Menopause.
Prazo: 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
Patrocinador
Investigadores
- Cadeira de estudo: Rosa Raventós Torner, RN, MSN, PhD, Universidad Rovira i Virgili
- Diretor de estudo: Cristina Rey Reñones, RN, MSN, PhD, Universidad Rovira Y Virgili
- Investigador principal: Rocío Legaz Pagán, PhD Student, RN, MSc, Universidad Rovira Y Virgili
- Diretor de estudo: Marina Gómez de Quero Cordoba, RN, MSN, PhD, Universidad Rovira Y Virgili
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 24/165-P
- 7722 (Outro identificador: PhD Program Student ID URV)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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