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

NCT07426263 | Active Not Recruiting DMC

• 1 other identifier: PET-SF
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Diseases

Keywords

Sexual education; Sexuality; Women; Cardiovascular diseases; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Hospital Anxiety and Depression

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

• Health-related quality of life

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

• Treatment adherence

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

Study Arms (2)

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.

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.

Behavioral: Usual Care

Interventions

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.

Intervention group

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.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Virgen Macarena: lead
• University of Seville: collaborator

Study Sites (1)

Virgen Macarena University Hospital. Seville (Spain)

Seville, 41020, Spain

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Sexuality

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): May 19, 2027
• Study Completion (Estimated): May 19, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-02

Locations

ES (1)