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
연구 개요
상태
정황
상세 설명
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
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hauts-de-Seine
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Garches, Hauts-de-Seine, 프랑스, 92380
- Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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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간섭 없음: Control arm
Usual care (no structured information or education on sexuality)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Female Sexual Function Index (FSFI) 12 months after returning home
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Hospital anxiety and depression scale (HAD)
기간: 12 months
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12 months
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London Handicap Scale (LHS)
기간: 12 months
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12 months
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Expectations of women in terms of care
기간: 12 months
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12 months
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Stability or change of sexual partner
기간: 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: François Giuliano, MD, PhD, Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital, 92380 Garches, France
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
척수 손상에 대한 임상 시험
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Rennes University Hospital완전한