Clinical trial NCT06278363: Sexual Nursing Care in Stroke Patients
Official title: The Role of Sexual Nursing Care in Managing Sexual Dysfunctions in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Sexual nursing care
sexuality
Sexual health
sexual dysfunction
Stroke
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We aim to assess the effectiveness of an intervention in stroke subjects to increase awareness of sexual health, effectively manage sexual dysfunctions, reduce their frequency, and enhance psychophysical well-being.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness
timeFrame: Patients are enrolled approximately one month after hospitalization following a stroke. They undergo bi-monthly outpatient sessions, indicating a continuous and structured treatment regimen.
Secondary outcomes:
measure: psychosocial well-being and relational dynamics of stroke patients and their partners
timeFrame: Patients are enrolled approximately one month after hospitalization following a stroke. They undergo bi-monthly outpatient sessions, indicating a continuous and structured treatment regimen.
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
state: Italy/Messina
Study officials:
affiliation: IRCCS Centro Neurolesi Bonino Pulejo
name: Provvidenza Tommasello, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calabro RS, Manuli A. Sexual Function and Disability in the Neurorehabilitation Setting: An Urgent Need for a Multidisciplinary Approach. Innov Clin Neurosci. 2021 Oct-Dec;18(10-12):26-27.
citation: Na Y, Htwe M, Rehman CA, Palmer T, Munshi S. Sexual dysfunction after stroke-A biopsychosocial perspective. Int J Clin Pract. 2020 Jul;74(7):e13496. doi: 10.1111/ijcp.13496. Epub 2020 Mar 5.