Sexual Nursing Care in Stroke Patients
StrokeSex_23
The Role of Sexual Nursing Care in Managing Sexual Dysfunctions in Stroke Patients
1 other identifier
interventional
113
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
February 9, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedMarch 28, 2024
March 1, 2024
8 months
February 9, 2024
March 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Study Arms (2)
Sexual Nursing Care
EXPERIMENTALGroup 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.
Standard Nursing Care:
ACTIVE COMPARATORPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Centro Neurolesi Bonino Pulejo
Messina, Italy/Messina, 98124, Italy
Related 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.
PMID: 35096479RESULTNa 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.
PMID: 32100415RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Provvidenza Tommasello, MsC
IRCCS Centro Neurolesi Bonino Pulejo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- co-investigator
Study Record Dates
First Submitted
February 9, 2024
First Posted
February 26, 2024
Study Start
November 1, 2023
Primary Completion
June 30, 2024
Study Completion
April 30, 2025
Last Updated
March 28, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
We are considering the use of a cloud database to share anonymized patient data with other researchers, which would involve making individual participant data (IPD) available.