Impact of an Information and Education Program on Sexuality and Social Integration in Women With a Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Female Sexual Function Index (FSFI) 12 months after returning home
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Female Sexual Function Index (FSFI) 12 months after returning home
时间窗: 12 months
次要结局
- 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)