Sexual Health of Spinal Cord Injured Females (SexSIFem)
Impact of an Information and Education Program on Sexuality and Social Integration in Women With a Spinal Cord Injury
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Patients enrolled in the control arm will undergo the same follow-up but will only have the usual unstructured and unformalized information provided by the clinical team.
At M3, M6, M12 secondary conditions , sexual function index (FSFI), social integration (LHS), treatment and expectations towards rehabilitation care will be assessed
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Hauts-de-Seine
-
Garches, Hauts-de-Seine, Frankrig, 92380
- Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: arm
Standardised information and education on sexuality in women with spinal cord injury
|
Program of information and education on the physiology of sexual response in women with spinal cord injury 6 months after their first return to home:
|
|
Ingen indgriben: Control arm
Usual care (no structured information or education on sexuality)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Female Sexual Function Index (FSFI) 12 months after returning home
Tidsramme: 12 months
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Hospital anxiety and depression scale (HAD)
Tidsramme: 12 months
|
12 months
|
|
London Handicap Scale (LHS)
Tidsramme: 12 months
|
12 months
|
|
Expectations of women in terms of care
Tidsramme: 12 months
|
12 months
|
|
Stability or change of sexual partner
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: François Giuliano, MD, PhD, Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P130912
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