Effectiveness of a Therapeutic Education Program on Female Sexuality in Women Attending Cardiac Rehabilitation.
NCT07426263 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2026-05-13
Summary
Cardiovascular disease is the leading cause of morbidity and mortality among women and is frequently associated with changes in sexual function, emotional distress, and reduced quality of life. In women, these difficulties are often influenced by gender-specific factors, including differences in clinical presentation, psychosocial roles, caregiving responsibilities, and the historical under-recognition of female sexuality within cardiovascular care. Although international clinical recommendations highlight the importance of addressing sexual health as part of comprehensive cardiac rehabilitation, this aspect remains insufficiently integrated into routine practice, particularly from a female-centered perspective.
This randomized controlled trial aims to evaluate the effectiveness of a Therapeutic Education Program on Female Sexuality (PET-SF), specifically designed and implemented within a hospital-based cardiac rehabilitation unit. The program is delivered as a structured, group-based, nurse-led educational intervention integrated into usual care. The primary outcome is female sexual function, while secondary outcomes include anxiety, depression, quality of life, and medication adherence. The study seeks to determine whether a gender-sensitive therapeutic education approach can improve sexual well-being and related psychosocial outcomes in women attending cardiac rehabilitation.
Conditions
Interventions
- BEHAVIORAL
-
Therapeutic Education Program on Female Sexuality (PET-SF)
The PET-SF is a structured, nurse-led, group-based therapeutic education program specifically developed for women undergoing cardiac rehabilitation. Unlike general cardiac education or brief counselling approaches, PET-SF focuses exclusively on female sexuality after cardiovascular disease and integrates clinical safety information with psychosocial and relational dimensions. The program is delivered in four structured sessions over approximately two weeks and is grounded in an educational framework inspired by the EX-PLISSIT model. It combines evidence-based information, normalization of concerns, communication skill development, and practical guidance to support safe resumption of sexual activity within a gender-sensitive approach integrated into routine cardiac rehabilitation.
- BEHAVIORAL
-
Usual Care
Participants allocated to the control group will receive usual care as provided within the standard cardiac rehabilitation program. Usual care includes multidisciplinary cardiovascular rehabilitation focusing on physical training, cardiovascular risk factor management, lifestyle modification, and medical follow-up. The control group will not receive the structured PET-SF educational intervention during the main study period. After completion of follow-up assessments, participants in the control group will be offered the opportunity to participate in the PET-SF program.
Sponsors & Collaborators
-
University of Seville
collaborator OTHER -
Hospital Universitario Virgen Macarena
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-18
- Primary Completion
- 2027-05-19
- Completion
- 2027-05-19
Countries
- Spain
Study Locations
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