Sexual Nursing Care in Stroke Patients

Stroke Clinical Trial

— StrokeSex_23  

Official title:

The Role of Sexual Nursing Care in Managing Sexual Dysfunctions in Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278363
• Other study ID #: StrokeSex_23
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: Rocco Salvatore Calabrò, MD,PhD
• Phone: +39-090-60128123
• Email: roccos.calabro[@]irccsme.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 113
• Est. completion date: April 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Sexual Nursing care
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.
• Standard Nursing Care
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.

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi Bonino Pulejo	Messina	Italy/Messina

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness	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.	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	psychosocial well-being and relational dynamics of stroke patients and their partners	The secondary aim is to assess the broader effects of "sexual nursing care" on the: psychosocial well-being and; relational dynamics of stroke patients and partners. Through tailored counseling and interventions, the investigators aim to improve the couple's dynamics and overall quality of life.; Outcome measures include: the Dyadic Adjustment Scale (DAS) for relational satisfaction; the WHOQOL-Brief Scale to monitor quality of life changes By evaluating these objectives, the investigators aim to understand the broader impacts of "sexual nursing care," contributing to enhanced psychosocial well-being and relationships in stroke patients and 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.