The Role of Sexual Nursing Care in Managing Sexual Dysfunctions in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness
研究概览
简要总结
The study aims to assess the impact of "sexual nursing care" on sexual dysfunctions in Italian stroke patients.
The method involves a randomized clinical trial with two groups: one receiving specific sexual care and the other standard care, both involving the partner. Various assessment scales are used, and four outpatient interventions are administered over six months.
Results indicate improvement in body awareness, management of sexual dysfunctions, relational dynamics, and quality of life for both patients and partners.
In conclusion, the importance of sexual health in stroke patients is highlighted as an indicator of quality of life. Targeted nursing interventions can facilitate timely diagnosis and a personalized approach to patients and partners.
详细描述
Introduction:
Stroke is a leading cause of disability in adults worldwide, affecting approximately 1.9-4.3% of individuals aged over 20. Patients often experience motor and cognitive issues post-stroke, with around 40% affected within a year. Moreover, sexual dysfunctions affect approximately 50% of stroke survivors, including erectile dysfunction and altered lubrication, impacting relationships and quality of life for both patients and caregivers.
Sexuality plays a significant role in an individual's overall well-being, yet the sexual health needs of stroke patients are often overlooked in clinical practice. This study aims to assess the role of sexual nursing care in addressing sexual dysfunctions among Italian stroke patients and improving overall psychophysical well-being.
Objectives of the Study:
The primary objective is to evaluate the effectiveness of sexual nursing care in enhancing sexual awareness, managing sexual dysfunctions, and improving overall psychophysical well-being among stroke patients. Secondary objectives include assessing improvements in psychorelational dynamics within couples and evaluating the benefits of nursing counseling on patients' and partners' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant Masking: Participants are unaware of the treatment they are receiving. This helps prevent biases in reporting outcomes based on knowledge of the treatment.
Care Provider Masking: The individuals providing care, such as therapists or nurses, are also unaware of the treatment assigned to each participant. This prevents them from inadvertently influencing outcomes based on their knowledge of the treatment.
Investigator Masking: The individuals responsible for collecting and analyzing the data are blinded to the treatment allocation. This helps ensure impartiality and prevents biases in data interpretation.
Outcomes Assessor Masking: Individuals responsible for assessing the outcomes of the study, such as evaluating patient progress or interpreting test results, are blinded to the treatment group to which participants belong. This prevents biases in outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and neuroradiological diagnosis of ischemic or hemorrhagic stroke.
- •Age between 18 and 70 years.
- •Patients in the subacute phase (1-3 months post-event).
排除标准
- •Pre-existing neurodegenerative diseases (e.g., multiple sclerosis).
- •Endocrine-metabolic and psychiatric pathologies that may interfere with sexual function.
- •Global aphasia or other cognitive impairments that hinder active participation in training.
研究组 & 干预措施
Sexual Nursing Care
Group 1 patients receive "Sexual Nursing Care," involving personalized counseling by a nurse to address sexual dysfunctions post-stroke. The intervention includes partner involvement to foster new intimacy, sexual education, and exercises. Four 45-minute outpatient sessions with the nurse and partner are provided. Any emerging issues requiring diagnostic investigation will be communicated to the referring specialist.
干预措施: Sexual Nursing care (Other)
Standard Nursing Care:
Patients in Group 2 receive a standard nursing care approach. In this group, no specific structured interventions for sexual dysfunctions are provided. Management of sexual dysfunctions occurs based on the clinical case and standard care approach.
Care sessions follow a routine program, without specific interventions for the sexual sphere.
As in Group 1, any emerging issues during treatment that require further diagnostic investigation will be communicated to the referring specialist.
Both groups will be evaluated for the impact of treatment not only quantitatively, through the analysis of the effect of counseling on sexual and relational aspects but also qualitatively, to investigate psychorelational changes and mood impact on the quality of life of the involved couples.
干预措施: Standard Nursing Care (Other)
结局指标
主要结局
Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness
时间窗: Patients are enrolled approximately one month after hospitalization following a stroke. They undergo bi-monthly outpatient sessions, indicating a continuous and structured treatment regimen.
The "sexual nursing care" intervention involves personalized counseling by trained nurses, partner involvement, sexual education, and guidance for improving sexual function. The primary outcome assesses the impact on increasing sexual health awareness in stroke patients and partners. Evaluation includes a semi-structured interview for sexual dysfunctions, Female Sexual Function Index (FSFI) for women, and International Index of Erectile Function (IIEF) for men.
次要结局
- psychosocial well-being and relational dynamics of stroke patients and their partners(Patients are enrolled approximately one month after hospitalization following a stroke. They undergo bi-monthly outpatient sessions, indicating a continuous and structured treatment regimen.)
研究者
Rocco Salvatore Calabrò
co-investigator
IRCCS Centro Neurolesi Bonino Pulejo