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
調査の概要
状態
条件
詳細な説明
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
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Hauts-de-Seine
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Garches、Hauts-de-Seine、フランス、92380
- Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：Control arm
Usual care (no structured information or education on sexuality)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Female Sexual Function Index (FSFI) 12 months after returning home
時間枠：12 months
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12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Hospital anxiety and depression scale (HAD)
時間枠：12 months
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12 months
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London Handicap Scale (LHS)
時間枠：12 months
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12 months
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Expectations of women in terms of care
時間枠：12 months
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12 months
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Stability or change of sexual partner
時間枠：12 months
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12 months
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協力者と研究者
捜査官
- 主任研究者：François Giuliano, MD, PhD、Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
脊髄損傷の臨床試験
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Memorial Sloan Kettering Cancer CenterUniversity of Pisa; University of California, San Francisco; The Champalimaud Centre, Lisbon,...積極的、募集していないメラノーマ | 肉腫 | 卵巣がん | 骨 | 軟部組織 | リンパ節 | CNS-Spinal CD/MEMBR、NOSアメリカ, イタリア, ポルトガル