Cardiovascular DiseasesNCT07426263
Effectiveness of a Therapeutic Education Program on Female Sexuality in Women Attending Cardiac Rehabilitation.
A study testing Therapeutic Education Program on Female Sexuality (PET-SF) in people with Cardiovascular Diseases, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Therapeutic Education Program on Female Sexuality (PET-SF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2026to 19 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Therapeutic Education Program on Female Sexuality in Women Attending Cardiac Rehabilitation: A Randomized Controlled Trial.
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Therapeutic Education Program on Female Sexuality (PET-SF), Usual Care
- Keywords
- Sexual education, Sexuality, Women, Cardiovascular diseases, Cardiac rehabilitation
- Medical subject headings
- Cardiovascular Diseases, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Education Program on Female Sexuality (PET-SF)Behavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Therapeutic Education Program on Female Sexuality (PET-SF); Behavioral: Usual Care |
| Control group | Active comparator | 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (T0) to follow-up (T2, 12-13 weeks)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline (T0) to follow-up (T2, 12-13 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start18 Feb 2026
- Primary completion19 May 2027 (estimated)
- Study completion19 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Collaborators
- University of Seville
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426263
- Sponsor's protocol ID
- PET-SF
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Therapeutic Education Program on Female Sexuality in Women Attending Cardiac Rehabilitation: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07426263
- Acronym / sponsor ID
- PET-SF
- Conditions
- Cardiovascular Diseases
- Keywords
- Sexual education, Sexuality, Women, Cardiovascular diseases, Cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Collaborators
- University of Seville
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 19 May 2027 (estimated)
- Study completion
- 19 May 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Therapeutic Education Program on Female Sexuality (PET-SF), Behavioral: Usual CareThe 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. |
| Control group | Active comparator | Behavioral: Usual CareAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
| Usual CareParticipants 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. | Behavioural | Control group, Intervention group |
Primary outcome
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.
3 secondary outcomes
Hospital Anxiety and Depression
Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)
Health-related quality of life
Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)
Treatment adherence
Time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Education Program on Female Sexuality (PET-SF) in people with Cardiovascular Diseases, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function (time frame: Change from baseline (T0) to follow-up (T2, 12-13 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.