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NCT Number: NCT07426263

Effectiveness of a Therapeutic Education Program on Female Sexuality in Women Attending Cardiac Rehabilitation.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Diseases Behavior Sexual Behavior Sexuality

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virgen Macarena University Hospital. Seville (Spain)

Seville, 41020, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic Education Program on Female Sexuality (PET-SF)

Behavioral

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.

Usual Care

Behavioral

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.

Primary outcomes

  1. Female Sexual Function

    Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)

    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.

Secondary outcomes

  1. Hospital Anxiety and Depression

    Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)

    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.

  2. Health-related quality of life

    Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)

    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.

  3. Treatment adherence

    Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Virgen Macarena

Other

Collaborators

  • University of Seville

Registry information

Official study title

Effectiveness of a Therapeutic Education Program on Female Sexuality in Women Attending Cardiac Rehabilitation: A Randomized Controlled Trial.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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