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
研究概览
地位
条件
详细说明
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
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Hauts-de-Seine
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Garches、Hauts-de-Seine、法国、92380
- Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：arm
Standardised information and education on sexuality in women with spinal cord injury
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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:
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无干预：Control arm
Usual care (no structured information or education on sexuality)
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Female Sexual Function Index (FSFI) 12 months after returning home
大体时间：12 months
|
12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Hospital anxiety and depression scale (HAD)
大体时间：12 months
|
12 months
|
|
London Handicap Scale (LHS)
大体时间：12 months
|
12 months
|
|
Expectations of women in terms of care
大体时间：12 months
|
12 months
|
|
Stability or change of sexual partner
大体时间：12 months
|
12 months
|
合作者和调查者
调查人员
- 首席研究员：François Giuliano, MD, PhD、Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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