- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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"
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rocío Legaz Pagán, PhD Student, RN, BcS
- Phone Number: 0034 +34646057662
- Email: rlegazpagan39@gmail.com
Study Contact Backup
- Name: Marina Gómez de Quero Cordoba, RN, MSN, PhD
- Email: marina.gomezdequero@urv.cat
Study Locations
-
-
-
Tarragona, Spain
- Recruiting
- Institut Català de la Salut (ICS) - Camp de Tarragona.
-
Contact:
- Marina Gómez de Quero Cordoba, RN, MSN, PhD
- Email: marina.gomezdequero@urv.cat
-
Contact:
- Rocío Legaz Pagán, RN, BcS, PhD Student
- Phone Number: 0034 646057662
- Email: rlegazpagan39@gmail.com
-
Principal Investigator:
- Rocío Legaz Pagán, RN, BcS, PhD Student
-
Sub-Investigator:
- Marina Gómez de Quero Cordoba, RN, MSN, PhD
-
Sub-Investigator:
- Rosa Raventós Torner, RN, MSN, PhD
-
Sub-Investigator:
- Cristina Rey Reñones, RN, MSN, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptions and Lived Experiences of Women in the Climacteric Stage.
Time Frame: 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.
Time Frame: 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.
|
Collaborators and Investigators
Investigators
- Study Chair: Rosa Raventós Torner, RN, MSN, PhD, Universidad Rovira i Virgili
- Study Director: Cristina Rey Reñones, RN, MSN, PhD, Universidad Rovira Y Virgili
- Principal Investigator: Rocío Legaz Pagán, PhD Student, RN, MSc, Universidad Rovira Y Virgili
- Study Director: Marina Gómez de Quero Cordoba, RN, MSN, PhD, Universidad Rovira Y Virgili
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24/165-P
- 7722 (Other Identifier: PhD Program Student ID URV)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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