protocolSection identificationModule nctId: NCT06278363, orgStudyIdInfo id: StrokeSex_23, briefTitle: Sexual Nursing Care in Stroke Patients, acronym: StrokeSex_23, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: IRCCS Centro Neurolesi "Bonino-Pulejo", class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: 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., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 113, type: ESTIMATED, armsInterventionsModule interventions name: Sexual Nursing care, interventions name: Standard Nursing Care, outcomesModule primaryOutcomes measure: Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness, secondaryOutcomes measure: psychosocial well-being and relational dynamics of stroke patients and their partners, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Centro Neurolesi Bonino Pulejo, status: RECRUITING, city: Messina, state: Italy/Messina, zip: 98124, country: Italy, contacts name: Maria Grazia Maggio, PsyD, PhD, role: CONTACT, phone: +39-09060128840, email: mariagrazia.maggio@irccsme.it, contacts name: Maria Grazia Maggio, PsyD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False