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

12 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Geschat)

25

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Rocío Legaz Pagán, PhD Student, RN, BcS
  • Telefoonnummer: 0034 +34646057662
  • E-mail: rlegazpagan39@gmail.com

Studie Contact Back-up

Studie Locaties

      • Tarragona, Spanje
        • Werving
        • Institut Català de la Salut (ICS) - Camp de Tarragona.
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Rocío Legaz Pagán, RN, BcS, PhD Student
        • Onderonderzoeker:
          • Marina Gómez de Quero Cordoba, RN, MSN, PhD
        • Onderonderzoeker:
          • Rosa Raventós Torner, RN, MSN, PhD
        • Onderonderzoeker:
          • Cristina Rey Reñones, RN, MSN, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Perceptions and Lived Experiences of Women in the Climacteric Stage.
Tijdsspanne: 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.
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie stoel: Rosa Raventós Torner, RN, MSN, PhD, Universidad Rovira i Virgili
  • Studie directeur: Cristina Rey Reñones, RN, MSN, PhD, Universidad Rovira Y Virgili
  • Hoofdonderzoeker: Rocío Legaz Pagán, PhD Student, RN, MSc, Universidad Rovira Y Virgili
  • Studie directeur: Marina Gómez de Quero Cordoba, RN, MSN, PhD, Universidad Rovira Y Virgili

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 april 2026

Primaire voltooiing (Geschat)

22 april 2028

Studie voltooiing (Geschat)

22 april 2030

Studieregistratiedata

Eerst ingediend

29 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2026

Eerst geplaatst (Werkelijk)

15 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

"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)."

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Geldige MeSH-voorwaarden

Klinische onderzoeken op Survey and Semi-structured Interview

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