Sexual Nursing Care in Stroke Patients (StrokeSex_23)

IRCCS Centro Neurolesi "Bonino-Pulejo"

Status: Enrolling

Conditions: Stroke

Treatments: Other: Standard Nursing Care; Other: Sexual Nursing care

Study type: Interventional

Funder types: Other

Identifiers

NCT06278363

StrokeSex_23

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 113 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

113 participants in 2 patient groups

Sexual Nursing Care

Experimental group

Description:

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.

Treatment:

Other: Sexual Nursing care

Standard Nursing Care:

Active Comparator group

Description:

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.

Treatment:

Other: Standard Nursing Care