Effectiveness of a Therapeutic Education Program on Female Sexuality in Women Attending Cardiac Rehabilitation: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Female Sexual Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
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.
干预措施: Therapeutic Education Program on Female Sexuality (PET-SF) (Behavioral)
Intervention group
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.
干预措施: Usual Care (Behavioral)
Control group
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.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Female Sexual Function
时间窗: 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.
次要结局
- 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))