- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03303326
Arab American Women's Health Study
연구 개요
상세 설명
Sexuality is an important aspect of health, in part because emotional conflicts over sexuality as well as unwanted sexual experiences can impact physical and psychological health; yet no studies have examined sexual health among Arab American women in the U.S. These women face the task of negotiating their heritage culture and the American culture in which they reside. This may result in bicultural identity conflict for some women as they try to negotiate these two identities, which may have implications for sexuality and sexual health due to the two cultures' disparate views on sexuality. Confidential discussion of these sensitive topics with a knowledgeable interviewer may yield beneficial effects.
The overall goal of the current study is to fill the gap in the literature on Arab American sexual health by examining how sexual health is related to physical and psychological health. This will be accomplished using both: a) correlational findings about sexual, physical, and psychological health from information gathered through self-report questionnaires and a 60-minute women's health interview; and b) an experimental test of the effects of the women's health interview on physical and psychological health. A sample of young adult Arab American women will be assessed at baseline via questionnaires for various constructs (sexual attitudes, cultural and religious identity, and physical and mental health), and then randomized to either an immediate or delayed health interview, with a 5-week follow-up reassessment.
It is hypothesized that lower sexual well-being, negative sexual self-schemas, and unwanted sexual experiences will correlate with more somatic and psychological health symptoms and lower satisfaction with life. It is also hypothesized that participants who have the immediate interview will report greater reduction in somatic and psychological symptoms and a greater willingness to discuss sexual health with medical providers compared to participants who are not interviewed (i.e., have a delayed interview after follow-up assessment).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Detroit, Michigan, 미국, 48201
- Wayne State University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Arab American or Chaldean
- Female
- Age 18-35
Exclusion Criteria:
- Non-English speaking
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Immediate Interview
A 60-minute interview about women's health conducted immediately after baseline questionnaires.
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A women's health interview that obtains information about physical, mental, and sexual health, particularly relatively private sexual health-related attitudes and experiences, as well as conflicts and stress related to sexuality.
다른 이름들:
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간섭 없음: Delayed Interview
The interview is conducted after the follow-up questionnaires are completed, rather than after baseline.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Health Questionnaire
기간: Change from baseline to 5-week follow-up
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Physical symptoms
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Change from baseline to 5-week follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Brief Symptom Inventory
기간: Change from baseline to 5-week follow-up
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Psychological symptoms
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Change from baseline to 5-week follow-up
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Satisfaction with Life Scale
기간: Change from baseline to 5-week follow-up
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Satisfaction with life
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Change from baseline to 5-week follow-up
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Sexual Self-Schema Scale
기간: Change from baseline to 5-week follow-up
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Sexual self-schemas
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Change from baseline to 5-week follow-up
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Sexual Self Disclosure Scale (Catania)
기간: Change from baseline to 5-week follow-up
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Self-reported ease or difficulty with disclosing information about sexuality
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Change from baseline to 5-week follow-up
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Sexual Self Disclosure Scale (Herold & Way)
기간: Change from baseline to 5-week follow-up
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Degree of past sexual disclosure
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Change from baseline to 5-week follow-up
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Female Sexual Function Index
기간: Change from baseline to 5-week follow-up
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Female sexual function
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Change from baseline to 5-week follow-up
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Sexual Satisfaction Scale for Women
기간: Change from baseline to 5-week follow-up
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Sexual satisfaction
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Change from baseline to 5-week follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mark Lumley, PhD, Wayne State University
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 064917B3E
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
Immediate interview에 대한 임상 시험
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)모집하지 않고 적극적으로
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Norwegian Institute of Public HealthStatistics Norway; Society of Interventional Oncology완전한
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Mahidol University완전한