- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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"
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Rocío Legaz Pagán, PhD Student, RN, BcS
- Telefonnummer: 0034 +34646057662
- E-mail: rlegazpagan39@gmail.com
Undersøgelse Kontakt Backup
- Navn: Marina Gómez de Quero Cordoba, RN, MSN, PhD
- E-mail: marina.gomezdequero@urv.cat
Studiesteder
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-
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Tarragona, Spanien
- Rekruttering
- Institut Català de la Salut (ICS) - Camp de Tarragona.
-
Kontakt:
- Marina Gómez de Quero Cordoba, RN, MSN, PhD
- E-mail: marina.gomezdequero@urv.cat
-
Kontakt:
- Rocío Legaz Pagán, RN, BcS, PhD Student
- Telefonnummer: 0034 646057662
- E-mail: rlegazpagan39@gmail.com
-
Ledende efterforsker:
- Rocío Legaz Pagán, RN, BcS, PhD Student
-
Underforsker:
- Marina Gómez de Quero Cordoba, RN, MSN, PhD
-
Underforsker:
- Rosa Raventós Torner, RN, MSN, PhD
-
Underforsker:
- Cristina Rey Reñones, RN, MSN, PhD
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceptions and Lived Experiences of Women in the Climacteric Stage.
Tidsramme: Baseline.
|
Exploration of the subjective experiences, cultural influences, and quality of life through thematic analysis of semi-structured interviews.
|
Baseline.
|
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Level of Knowledge and Attitudes of Healthcare Professionals Regarding Menopause.
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Rosa Raventós Torner, RN, MSN, PhD, Universidad Rovira i Virgili
- Studieleder: Cristina Rey Reñones, RN, MSN, PhD, Universidad Rovira Y Virgili
- Ledende efterforsker: Rocío Legaz Pagán, PhD Student, RN, MSc, Universidad Rovira Y Virgili
- Studieleder: Marina Gómez de Quero Cordoba, RN, MSN, PhD, Universidad Rovira Y Virgili
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 24/165-P
- 7722 (Anden identifikator: PhD Program Student ID URV)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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