Nursing program to improve mental well-being and self-care during the climacteric
Nursing Interventions to Enhance Positive Mental Health and Self Care in Women During the Climacteric
This program will test whether nurse-led podcasts and videos help women aged 42–58 feel better and take better care of themselves during the climacteric.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 42 Years to 58 Years |
| Sex | Female |
| Sponsor | University of Barcelona Academic / other |
| Locations | 1 site (L'Hospitalet de Llobregat, Barcelona) |
| Trial ID | NCT07165964 on ClinicalTrials.gov |
What this trial studies
Women aged 42–58 attending public sexual and reproductive health clinics in the Metropolitan South Health Region of Barcelona are randomly assigned to an intervention group that receives podcasts and videos with practical nursing advice or to a control group receiving standard care. Participants complete questionnaires before and after the program to measure climacteric symptoms, positive mental health, and satisfaction with self-care. Outcomes will be compared using statistical methods to determine whether the digital nursing program produces significant improvements. The intervention is grounded in Dorothea Orem's Self-Care Deficit theory and aims to address both emotional well-being and self-care capacity.
Who should consider this trial
Good fit: Ideal candidates are women aged 42–58 with clinically identified climacteric symptoms who attend the participating ASSIR centers in the Metropolitan South Health Region of Barcelona.
Not a fit: Women with cognitive or learning impairments, those currently treated for hormone-dependent cancer, using an intrauterine device or ongoing hormonal contraceptives, or with other medical causes of secondary menopause are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could improve emotional well-being and self-care behaviors in menopausal women, easing climacteric symptoms and improving quality of life.
How similar studies have performed: Programs specifically combining positive mental health and self-care support during the climacteric are scarce, so this nurse-led digital approach is relatively novel, although related lifestyle and empowerment interventions have shown some positive effects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 42-58 years attending the participating ASSIR centers. * Clinically identified symptoms of climacteric during routine consultation. Exclusion Criteria: * Cognitive or learning impairments preventing comprehension of study procedures. * Physical, emotional, or intellectual limitations hindering completion of study instruments or participation in the intervention. * Current treatment for hormone dependent cancer. * Use of an intrauterine device or ongoing hormonal contraceptives. * Other medical causes of secondary menopause.
Where this trial is running
L'Hospitalet de Llobregat, Barcelona
- Universitat de Barceñpma — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Monsterrat Puig-Llobet — Universitat de Barelona
- Study coordinator: Monste Puig-Llobet, Monsterrat, Professor
- Email: monpuigllob@ub.edu
- Phone: 934 02 42 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.