Valid MeSH ConditionsVIMEC-ICNCT07648680
"Menopause Experiences in Cultural and Intercultural Contexts"
An observational study of Valid MeSH Conditions, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Valid MeSH Conditions
- What is being tested?
- Survey and Semi-structured Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 27 Apr 2026to 22 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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):
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marina Gómez de Quero Cordoba, RN, MSN, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Institut Català de la Salut (ICS) - Camp de Tarragona.
Tarragona
Rocío Legaz Pagán, RN, BcS, PhD Student, 646057662 ext. 0034, rlegazpagan39@gmail.com
Marina Gómez de Quero Cordoba, RN, MSN, PhD, marina.gomezdequero@urv.cat
About this study
Official title: "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.
Read the 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.
- Conditions
- Valid MeSH Conditions
- Being tested
- Survey and Semi-structured Interview
- Keywords
- Menopause, quality of life, physical activity, Mediterranean Diet, Nursing
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey and Semi-structured InterviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Survey and Semi-structured Interview | |
| 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. Receives: Behavioral: Survey and Semi-structured Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions and Lived Experiences of Women in the Climacteric Stage.
Exploration of the subjective experiences, cultural influences, and quality of life through thematic analysis of semi-structured interviews.
Measured: Baseline.
Level of Knowledge and Attitudes of Healthcare Professionals Regarding Menopause.
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.
Measured: Baseline at the time of survey completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start27 Apr 2026
- Primary completion22 Apr 2028 (estimated)
- Study completion22 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valid MeSH ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa Raventós Torner, RN, MSN, PhD, Study chair, Universidad Rovira i VirgiliCristina Rey Reñones, RN, MSN, PhD, Study director, Universidad Rovira Y VirgiliRocío Legaz Pagán, PhD Student, RN, MSc, Principal investigator, Universidad Rovira Y VirgiliMarina Gómez de Quero Cordoba, RN, MSN, PhD, Study director, Universidad Rovira Y Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648680
- Sponsor's protocol ID
- 24/165-P
- Other IDs
- 7722
- Acronym
- VIMEC-IC
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "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)."
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Menopause Experiences in Intercultural Contexts and Healthcare Professionals: A Mixed- Methods Study Protocol in Community Settings"
- ClinicalTrials.gov ID
- NCT07648680
- Acronym / sponsor ID
- VIMEC-IC / 24/165-P
- Conditions
- Valid MeSH Conditions
- Keywords
- Menopause, quality of life, physical activity, Mediterranean Diet, Nursing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 22 Apr 2028 (estimated)
- Study completion
- 22 Apr 2030 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare Professionals | – | Behavioral: Survey and Semi-structured InterviewPrimary 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. |
| Women in Climacteric Stage | – | Behavioral: Survey and Semi-structured InterviewWomen 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
- Women aged 40 to 65 years.
Key exclusion criteria (6 listed)
- Refusal to participate in the study or incomplete electronic survey.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey and Semi-structured InterviewFor 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. | Behavioural | Healthcare Professionals, Women in Climacteric Stage |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. "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)."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marina Gómez de Quero Cordoba, RN, MSN, PhD contact
Rosa Raventós Torner, RN, MSN, PhD study chair
Universidad Rovira i Virgili
Cristina Rey Reñones, RN, MSN, PhD study director
Universidad Rovira Y Virgili
Rocío Legaz Pagán, PhD Student, RN, MSc principal investigator
Universidad Rovira Y Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valid MeSH Conditions, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rocío Legaz Pagán, PhD Student, RN, BcS (+34646057662 ext. 0034, rlegazpagan39@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptions and Lived Experiences of Women in the Climacteric Stage. (time frame: Baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.