IRCCS Centro Neurolesi Bonino Pulejo
Messina, Italy/Messina, 98124, Italy
NCT Number: NCT06278363
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Messina, Italy/Messina, 98124, Italy
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.
Study Population:
The study will include patients with ischemic and hemorrhagic stroke admitted to the Physical Medicine and Rehabilitation Unit of AOU Policlinico "G. Martino" in Messina, Italy, during the subacute phase (1-3 months post-event).
Inclusion criteria
Clinical and neuroradiological diagnosis of stroke, aged 18-70 years.
Exclusion criteria
Pre-existing neurodegenerative diseases, endocrine-metabolic and psychiatric conditions interfering with sexual function, global aphasia, or other cognitive impairments hindering active participation.
Study Design and Procedures:
The study will employ a randomized clinical trial (RCT) design with block randomization. Patients will be allocated into two groups: Group 1 (GS) receiving sexual nursing care and Group 2 (GC) receiving standard nursing care. Both groups will involve the partner.
Before enrollment, patients will undergo a comprehensive assessment to identify contraindications and ensure adherence to exclusion criteria.
Sexual nursing care interventions will include counseling, sexual education, and exercises for sexual function improvement. Four outpatient interventions will be conducted bimonthly, each lasting 45 minutes and involving the nurse, patient, and partner.
The study will utilize a mixed-method approach, combining a quantitative assessment of counseling effects on sexual-relational aspects with a qualitative investigation into psychoemotional changes and mood disorders impacting the quality of life in stroke-affected couples.
Outcome Measures:
A battery of tests will be administered at baseline (T0), 3 months (T1), and 6 months (T2) to evaluate outcomes. Trained nurses, blinded to patient groupings, will conduct clinical scale assessments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Sexual Nursing Care approach is a specialized intervention for stroke patients and partners, addressing sexual health needs. It includes personalized counseling sessions with trained nurses, assessing dysfunctions and medical history. Active partner involvement fosters intimacy and understanding. Both receive sexual education covering anatomy, physiology, and post-stroke changes. Recommendations for activities like Kegel exercises are provided. Structured outpatient sessions occur, lasting 45 minutes, facilitated by a nurse. Pre- and post-treatment assessments are conducted to identify contraindications. Emerging issues during treatment are promptly communicated for management. Sexual Nursing Care aims to holistically address post-stroke sexual health and relational needs, improving awareness and communication.
Coaching and Counselling can be provided also via telemedicine.
Group 2 patients receive standard nursing care without structured interventions for sexual dysfunctions. Management relies on clinical case and routine care procedures. No specific sexual sphere interventions are provided. Any emerging issues needing diagnostic investigation are reported to the specialist. Both groups are assessed quantitatively for counseling effects on sexual and relational aspects and qualitatively for psychorelational changes and mood impact on couple's quality of life.
Time frame: 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.
Time frame: 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 secondary aim is to assess the broader effects of "sexual nursing care" on the:
Outcome measures include:
IRCCS Centro Neurolesi Bonino Pulejo
Other
The Role of Sexual Nursing Care in Managing Sexual Dysfunctions in Stroke Patients
Acronym: StrokeSex_23
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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