Impact of an Information and Education Program on Sexuality and Social Integration in Women With a Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Female Sexual Function Index (FSFI) 12 months after returning home
Study Overview
Brief Summary
The purpose of this study is to assess the impact on sexuality in women with a spinal cord injury, twelve months after their first return to home, of a program including structured information and education on sexuality, delivered 6 months after their first return to home.
Detailed Description
Multicentre, prospective study, aiming to assess the effect on sexuality of an information and education program in women with spinal cord injury.
Included patients will be women hospitalized for initial rehabilitation, and will be included two weeks before their first return to home.
Socio-demographic data, diagnosis and etiology, secondary conditions, treatment, comorbidities and expectations towards rehabilitation care will be assessed at inclusion.
At M3 Patients will be randomized in either the intervention arm or the control arm.
Patients enrolled in the intervention arm will benefit from a standardised information and education consultation on physiology of sexual response 6 months after their return home.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Spinal cord injury including cauda equina injury of traumatic etiology or not
- •Hospitalization for initial post-injury rehabilitation in a study center
- •First return at home scheduled within the 14 days following inclusion date
- •Understanding of the French language allowing to answer questionnaires
- •Affiliation to health insurance
- •Written informed consent
Exclusion Criteria
- •Full recovery of sensory-motor functions (AISE)
- •Associated brain injury
- •Psychiatric disease previously diagnosed, excepted treated and remitting mood disorders
- •Patients with tutorship / guardianship
- •Spinal cord injury of malignant origin
- •Spinal cord injury associated with multiple sclerosis
- •Anticipated loss-to-follow-up (patient moving outside of the usual hospital catchment area)
Arms & Interventions
arm
Standardised information and education on sexuality in women with spinal cord injury
Intervention: Standardised information and education on sexuality in women with spinal cord injury (Other)
Control arm
Usual care (no structured information or education on sexuality)
Outcomes
Primary Outcomes
Female Sexual Function Index (FSFI) 12 months after returning home
Time Frame: 12 months
Secondary Outcomes
- Expectations of women in terms of care(12 months)
- Stability or change of sexual partner(12 months)
- Hospital anxiety and depression scale (HAD)(12 months)
- London Handicap Scale (LHS)(12 months)