Effectiveness of a Therapeutic Education Program on Female Sexuality in Women Attending Cardiac R… (NCT07426263) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effectiveness of a Therapeutic Education Program on Female Sexuality in Women Attending Cardiac Rehabilitation.
Spain66 participantsStarted 2026-02-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Women will be eligible to participate if they meet all of the following criteria:
* Female sex.
* Age 18 years or older.
* Referral to a hospital-based Cardiac Rehabilitation Unit following a cardiovascular event.
* Clinical stability and medical clearance to participate in the cardiac rehabilitation program.
* Ability to understand the study information and provide written informed consent.
Exclusion Criteria:
Women will be excluded if any of the following criteria apply:
* Severe cognitive impairment or language barriers that preclude understanding of the intervention or study procedures.
* Recent participation in structured sexual education or sexual counselling programs.
* Inability to attend the sessions assigned within the intervention period.
* Attendance at fewer than two sessions of the intervention program.
* Occurrence of clinical complications or hospital readmission during the study period that prevent continued participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Female Sexual Function
Timeframe: Change from baseline (T0) to follow-up (T2, 12-13 weeks)