Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278363
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-02-09
Brief Title:
Sexual Nursing Care in Stroke Patients
Sponsor:
IRCCS Centro Neurolesi Bonino-Pulejo
Organization:
IRCCS Centro Neurolesi Bonino-Pulejo
Study Overview
Official Title:
The Role of Sexual Nursing Care in Managing Sexual Dysfunctions in Stroke Patients
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StrokeSex_23
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
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 19-43 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 individuals 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
Stroke is a leading cause of disability in adults worldwide affecting approximately 19-43 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 individuals 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None