StrokeStrokeSex_23NCT06278363
Sexual Nursing Care in Stroke Patients
A study testing Sexual Nursing care and Standard Nursing Care in people with Stroke, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Sexual Nursing care and Standard Nursing Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Sexual Nursing Care in Managing Sexual Dysfunctions in Stroke Patients
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.
Read more
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Sexual Nursing care, Standard Nursing Care
- Keywords
- Sexual nursing care, sexuality, Sexual health, sexual dysfunction, Stroke
- Medical subject headings
- Stroke, Sexuality, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Nursing careOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sexual Nursing Care | Experimental | 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. Receives: Other: Sexual Nursing care |
| Standard Nursing Care: | Active comparator | 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. Receives: Other: Standard Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Patients are enrolled approximately one month after hospitalization following a stroke. They undergo bi-monthly outpatient sessions, indicating a continuous and structured treatment regimen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Nov 2023
- Primary completion30 Jan 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocco Salvatore Calabrò, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Provvidenza Tommasello, MsC, Principal investigator, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278363
- Sponsor's protocol ID
- StrokeSex_23
- Acronym
- StrokeSex_23
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35096479Na 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.
PubMed 32100415
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sexual Nursing Care in Managing Sexual Dysfunctions in Stroke Patients
- ClinicalTrials.gov ID
- NCT06278363
- Acronym / sponsor ID
- StrokeSex_23 / StrokeSex_23
- Conditions
- Stroke
- Keywords
- Sexual nursing care, sexuality, Sexual health, sexual dysfunction, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sexual Nursing Care | Experimental | Other: Sexual Nursing careGroup 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 comparator | Other: Standard Nursing CarePatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual Nursing careThe 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. | Other | Sexual Nursing Care |
| Standard Nursing CareGroup 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. | Other | Standard Nursing Care: |
Primary outcome
Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness
Time frame: Patients are enrolled approximately one month after hospitalization following a stroke. They undergo bi-monthly outpatient sessions, indicating a continuous and structured treatment regimen.
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.
1 secondary outcome
psychosocial well-being and relational dynamics of stroke patients and their partners
Time frame: Patients are enrolled approximately one month after hospitalization following a stroke. They undergo bi-monthly outpatient sessions, indicating a continuous and structured treatment regimen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Results publication: PubMed 35096479Calabro 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.
- Results publication: PubMed 32100415Na 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Provvidenza Tommasello, MsC principal investigator
IRCCS Centro Neurolesi Bonino Pulejo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Nursing care and Standard Nursing Care in people with Stroke, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness (time frame: Patients are enrolled approximately one month after hospitalization following a stroke. They undergo bi-monthly outpatient sessions, indicating a continuous and structured treatment regimen.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06278363, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.