- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03303326
Arab American Women's Health Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Michigan
-
Detroit, Michigan, Forente stater, 48201
- Wayne State University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Arab American or Chaldean
- Female
- Age 18-35
Exclusion Criteria:
- Non-English speaking
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
|
|
Ingen inngripen: Delayed Interview
The interview is conducted after the follow-up questionnaires are completed, rather than after baseline.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
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Female Sexual Function Index
Tidsramme: Change from baseline to 5-week follow-up
|
Female sexual function
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mark Lumley, PhD, Wayne State University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 064917B3E
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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