- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03303326
Arab American Women's Health Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48201
- Wayne State University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Arab American or Chaldean
- Female
- Age 18-35
Exclusion Criteria:
- Non-English speaking
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Immediate Interview
A 60-minute interview about women's health conducted immediately after baseline questionnaires.
|
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.
Andre navne:
|
|
Ingen indgriben: Delayed Interview
The interview is conducted after the follow-up questionnaires are completed, rather than after baseline.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient Health Questionnaire
Tidsramme: Change from baseline to 5-week follow-up
|
Physical symptoms
|
Change from baseline to 5-week follow-up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Brief Symptom Inventory
Tidsramme: Change from baseline to 5-week follow-up
|
Psychological symptoms
|
Change from baseline to 5-week follow-up
|
|
Satisfaction with Life Scale
Tidsramme: Change from baseline to 5-week follow-up
|
Satisfaction with life
|
Change from baseline to 5-week follow-up
|
|
Sexual Self-Schema Scale
Tidsramme: Change from baseline to 5-week follow-up
|
Sexual self-schemas
|
Change from baseline to 5-week follow-up
|
|
Sexual Self Disclosure Scale (Catania)
Tidsramme: Change from baseline to 5-week follow-up
|
Self-reported ease or difficulty with disclosing information about sexuality
|
Change from baseline to 5-week follow-up
|
|
Sexual Self Disclosure Scale (Herold & Way)
Tidsramme: Change from baseline to 5-week follow-up
|
Degree of past sexual disclosure
|
Change from baseline to 5-week follow-up
|
|
Female Sexual Function Index
Tidsramme: Change from baseline to 5-week follow-up
|
Female sexual function
|
Change from baseline to 5-week follow-up
|
|
Sexual Satisfaction Scale for Women
Tidsramme: Change from baseline to 5-week follow-up
|
Sexual satisfaction
|
Change from baseline to 5-week follow-up
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mark Lumley, PhD, Wayne State University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 064917B3E
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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