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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Hauts-de-Seine
-
Garches, Hauts-de-Seine, Frankrike, 92380
- Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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:
|
|
Inget ingripande: Control arm
Usual care (no structured information or education on sexuality)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Female Sexual Function Index (FSFI) 12 months after returning home
Tidsram: 12 months
|
12 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Hospital anxiety and depression scale (HAD)
Tidsram: 12 months
|
12 months
|
|
London Handicap Scale (LHS)
Tidsram: 12 months
|
12 months
|
|
Expectations of women in terms of care
Tidsram: 12 months
|
12 months
|
|
Stability or change of sexual partner
Tidsram: 12 months
|
12 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: François Giuliano, MD, PhD, Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P130912
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