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"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"

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.

Studieoversikt

Status

Rekruttering

Detaljert 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:

  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.

Studietype

Observasjonsmessig

Registrering (Antatt)

25

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

      • Tarragona, Spania
        • Rekruttering
        • Institut Català de la Salut (ICS) - Camp de Tarragona.
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rocío Legaz Pagán, RN, BcS, PhD Student
        • Underetterforsker:
          • Marina Gómez de Quero Cordoba, RN, MSN, PhD
        • Underetterforsker:
          • Rosa Raventós Torner, RN, MSN, PhD
        • Underetterforsker:
          • Cristina Rey Reñones, RN, MSN, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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.
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Rosa Raventós Torner, RN, MSN, PhD, Universidad Rovira i Virgili
  • Studieleder: Cristina Rey Reñones, RN, MSN, PhD, Universidad Rovira Y Virgili
  • Hovedetterforsker: Rocío Legaz Pagán, PhD Student, RN, MSc, Universidad Rovira Y Virgili
  • Studieleder: Marina Gómez de Quero Cordoba, RN, MSN, PhD, Universidad Rovira Y Virgili

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. april 2026

Primær fullføring (Antatt)

22. april 2028

Studiet fullført (Antatt)

22. april 2030

Datoer for studieregistrering

Først innsendt

29. mai 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

"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)."

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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