- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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"
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rocío Legaz Pagán, PhD Student, RN, BcS
- Numéro de téléphone: 0034 +34646057662
- E-mail: rlegazpagan39@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Marina Gómez de Quero Cordoba, RN, MSN, PhD
- E-mail: marina.gomezdequero@urv.cat
Lieux d'étude
-
-
-
Tarragona, Espagne
- Recrutement
- Institut Català de la Salut (ICS) - Camp de Tarragona.
-
Contact:
- Marina Gómez de Quero Cordoba, RN, MSN, PhD
- E-mail: marina.gomezdequero@urv.cat
-
Contact:
- Rocío Legaz Pagán, RN, BcS, PhD Student
- Numéro de téléphone: 0034 646057662
- E-mail: rlegazpagan39@gmail.com
-
Chercheur principal:
- Rocío Legaz Pagán, RN, BcS, PhD Student
-
Sous-enquêteur:
- Marina Gómez de Quero Cordoba, RN, MSN, PhD
-
Sous-enquêteur:
- Rosa Raventós Torner, RN, MSN, PhD
-
Sous-enquêteur:
- Cristina Rey Reñones, RN, MSN, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
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.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Perceptions and Lived Experiences of Women in the Climacteric Stage.
Délai: 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.
Délai: 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.
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Rosa Raventós Torner, RN, MSN, PhD, Universidad Rovira i Virgili
- Directeur d'études: Cristina Rey Reñones, RN, MSN, PhD, Universidad Rovira Y Virgili
- Chercheur principal: Rocío Legaz Pagán, PhD Student, RN, MSc, Universidad Rovira Y Virgili
- Directeur d'études: Marina Gómez de Quero Cordoba, RN, MSN, PhD, Universidad Rovira Y Virgili
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 24/165-P
- 7722 (Autre identifiant: PhD Program Student ID URV)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Conditions MeSH valides
-
Kıvanç AkçaHacettepe UniversityComplétéCimentation (ID unique MeSH : D002484) | Conception d'implant dentaire et de pilier (ID unique MeSH : D059605) | Couronne (ID unique MeSH : D003442) Surfaces | Contour : Couronne (MeSH Unique ID : D003442) - Implant dentaire (MeSH Unique ID : D015921) PilierTurquie
-
Max Healthcare Insititute LimitedComplétéConditions MeSH validesInde
-
Hacettepe UniversityComplétéCouronnes (ID unique MeSH : D003442), dent unique | Porcelaine dentaire (ID unique MeSH : D003776)
-
National Cheng-Kung University HospitalPas encore de recrutement
-
Beatrice BaumerInconnueIndex glycémique (MeSH T483740)Suisse
-
Limin ZhangRecrutementRechercher MeSHChine
-
High Point UniversityComplétéAmélioration des performances des golfeuses amateurs (terme MESH : composition corporelle)États-Unis
-
Northwell HealthRésiliéStéatose hépatique non alcoolique | Probiotiques MeSH Descriptor Data 2018 | Interleukine-17 MeSH Descriptor Data 2018États-Unis
-
Inje UniversityComplété
-
Tianjin Medical University Cancer Institute and...RecrutementReconstruction mammaire par implant | Soutien-gorge TiLOOP® Mesh | Patch péricardique bovinChine
Essais cliniques sur Survey and Semi-structured Interview
-
The Hong Kong Polytechnic UniversityNethersole Institute of Continuing Holistic Health Education (NICHE)Pas encore de recrutementHospitalisation psychiatrique
-
Nantes University HospitalFondation de France; Nantes UniversityRecrutementDéprescription | Soins palliatifs | OncologieFrance
-
Institut de Cancérologie de LorraineRecrutement