An interventional study of Therapeutic Education Program on Female Sexuality (PET-SF) and Usual Care in Cardiovascular Diseases, sponsored by Hospital Universitario Virgen Macarena. Active, not recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Hospital Universitario Virgen Macarena · Not applicable, Interventional, and Supportive care
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.
Women with cardiovascular disease frequently experience changes in sexual function and intimate relationships following a cardiac event. These changes may be related to physiological alterations, psychological responses such as fear and anxiety, the effects of pharmacological treatment, and sociocultural determinants associated with gender norms. Despite their clinical relevance, sexual health concerns in women are often overlooked in cardiovascular care, and structured, gender-sensitive interventions addressing sexuality are rarely incorporated into cardiac rehabilitation programs.
This study is a unicenter, parallel, randomized controlled trial with a 1:1 allocation ratio, conducted in the Cardiac Rehabilitation Unit of Hospital Universitario Virgen Macarena (Seville, Spain). Adult women referred to cardiac rehabilitation after a cardiovascular event will be randomly assigned to either the intervention group, receiving the Therapeutic Education Program on Female Sexuality (PET-SF) in addition to usual care, or to a control group receiving usual care alone.
The PET-SF is a therapeutic education intervention specifically developed to address female sexuality in the context of cardiovascular disease. It is delivered in a group format by a qualified nurse and is based on a structured educational framework inspired by the EX-PLISSIT model. The program consists of four sessions delivered over approximately four weeks and addresses clinical and psychosocial dimensions such as sexual safety after cardiovascular events, the impact of disease and pharmacological treatment on sexual function, emotional and relational aspects, communication skills, and practical recommendations aimed at facilitating sexual well-being.
Assessments will be performed at baseline (T0), post-intervention (T1, 8-9 weeks), and follow-up (T2, 12-13 weeks). The primary outcome is change in female sexual function measured using the Female Sexual Function Index (FSFI). Secondary outcomes include symptoms of anxiety and depression, health-related quality of life, and medication adherence. The primary analysis will follow the intention-to-treat principle, with complementary per-protocol analyses conducted to assess the robustness of the findings.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 66 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Hospital Universitario Virgen Macarena is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women will be eligible to participate if they meet all of the following criteria:
Exclusion Criteria:
Women will be excluded if any of the following criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group will receive the Therapeutic Education Program on Female Sexuality (PET-SF) in addition to usual cardiac care. PET-SF is a structured, nurse-led, group intervention specifically for women with cardiovascular disease. It consists of four sessions over two weeks within the cardiac rehabilitation unit. Grounded in the EX-PLISSIT model, the program addresses clinical and psychosocial dimensions of sexuality after a cardiovascular event. Core components include sexual safety, the impact of conditions and pharmacological treatments on sexual function, emotional and relational aspects, communication skills, and practical recommendations for the safe resumption of sexual activity. Sessions are group-based and integrated into the standard rehabilitation schedule.
Behavioral: Therapeutic Education Program on Female Sexuality (PET-SF) · Behavioral: Usual Care
All participants enrolled in the study will receive standard multidisciplinary cardiac rehabilitation care as routinely provided in the hospital-based program. Usual care includes supervised physical training, cardiovascular risk factor management, lifestyle counselling, medical follow-up, and general health education. The standard rehabilitation program does not include a structured or gender-specific intervention specifically addressing female sexuality. Sexual health topics may be mentioned as part of general counselling, but no dedicated sessions focused on female sexual function are routinely provided.
Behavioral: Usual Care
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.
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.
Female Sexual Function
Instrument: Female Sexual Function Index (FSFI-19). The Female Sexual Function Index is a validated 19-item questionnaire assessing six domains of female sexual function over the previous four weeks: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2 to 36, with higher scores indicating better sexual function (less dysfunction and less pain). A total score of ≤26-26.55 is commonly used as a threshold suggestive of sexual dysfunction. Clinical improvement will be interpreted as a change from a baseline score \<26 to ≥26 and/or a moderate effect size (≥0.5) in score change over time, in accordance with established interpretation guidelines.
Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)
Hospital Anxiety and Depression
Instrument: Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items with two subscales: anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items). Each item is scored from 0 to 3, so each subscale ranges from 0 to 21 points (0 = better, 21 = worse). Higher scores indicate greater severity of anxiety or depression (worse outcome). Commonly used cut-off scores (e.g., ≥8 points on each subscale) will be applied to identify clinical cases. In this study, the intervention will be considered to produce a clinically relevant improvement when the mean change in HADS-A or HADS-D between baseline and post-intervention or follow-up is ≥2 points and/or when participants move from scores indicative of a clinical case to non-case status, according to these cut-offs.
Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)
Health-related quality of life
Instrument: Health-related quality of life will be assessed using the EuroQol 5-Dimensions 5-Levels questionnaire (EQ-5D-5L). The instrument includes a five-dimension descriptive system, each with five levels of severity (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a health state is defined and a summary index is obtained by applying the validated Spanish value set. The index typically ranges from values below 0 (health states considered worse than death) to 1.00 (full health), with higher scores indicating better health status. A clinically relevant improvement will be considered as an increase of ≥0.05 points in the index score. In addition, the visual analogue scale (EQ VAS) will be used, which rates perceived health status from 0 (worst imaginable health) to 100 (best imaginable health); a clinically relevant improvement will be considered as an increase of ≥7 points in the EQ VAS.
Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)
Treatment adherence
Instrument: Medication adherence will be assessed using the Morisky-Green questionnaire (MMAS-4), a 4-item self-report scale with Yes/No answers regarding habitual medication use. The questionnaire will be self-administered on paper at the three assessment points (T0, T1 and T2) within the PET-SF. Each item is answered with "Yes" or "No". According to the original criteria, high adherence will be defined only when the following pattern of answers is obtained: Question 1 → No Question 2 → Yes Question 3 → No Question 4 → No Any other response pattern will be classified as low adherence. Results will be interpreted dichotomously (high vs. low adherence), and changes over time (T0, T1, T2) in the proportion of women achieving high adherence will be analysed.
Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)
Started Feb 2026 (actual). Primary completion is estimated for May 2027, 15 months after the start.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 15 months is below that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Virgen Macarena