NCT07648680

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
47mo left

Started Apr 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Apr 2030

Study Start

First participant enrolled

April 27, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 29, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2030

Last Updated

June 15, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 29, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

Menopausequality of lifephysical activityMediterranean DietNursing

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline at the time of survey completion.

Study Arms (2)

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.

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.

Behavioral: Survey and Semi-structured Interview

Interventions

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.

Healthcare ProfessionalsWomen in Climacteric Stage

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Català de la Salut (ICS) - Camp de Tarragona.

Tarragona, Spain

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Rosa Raventós Torner, RN, MSN, PhD

    Universidad Rovira i Virgili

    STUDY CHAIR
  • Cristina Rey Reñones, RN, MSN, PhD

    Universidad Rovira Y Virgili

    STUDY DIRECTOR
  • Rocío Legaz Pagán, PhD Student, RN, MSc

    Universidad Rovira Y Virgili

    PRINCIPAL INVESTIGATOR
  • Marina Gómez de Quero Cordoba, RN, MSN, PhD

    Universidad Rovira Y Virgili

    STUDY DIRECTOR

Central Study Contacts

Rocío Legaz Pagán, PhD Student, RN, BcS

CONTACT

Marina Gómez de Quero Cordoba, RN, MSN, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2026

First Posted

June 15, 2026

Study Start

April 27, 2026

Primary Completion (Estimated)

April 22, 2028

Study Completion (Estimated)

April 22, 2030

Last Updated

June 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

"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)."

Locations