- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07570732
Occupational Disruption and Role Strain During Perimenopause
Occupational Disruption and Role Strain During Perimenopause: A Mixed-Methods Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Perimenopause is associated with fatigue, sleep disturbance, vasomotor symptoms, mood changes, and cognitive difficulties. While the literature addresses symptom management, limited research examines the functional impact of perimenopause on daily occupations, work participation, and role performance. Occupational therapy (OT) emphasizes participation in meaningful activities; however, there is minimal research exploring occupational disruption during midlife hormonal transition. This study aims to add to the OT literature. The study aims to explore the question: How do perimenopausal symptoms impact occupational performance, role participation, and occupational balance in midlife women?
- Is perimenopausal symptom severity associated with decreased occupational balance?
- Is symptom severity associated with reduced role participation?
- How do women describe the impact of perimenopause on daily occupations? The proposed study will examine how perimenopausal symptoms influence: Work performance, Home responsibilities, cognitive functioning, sleep and fatigue, and occupational balance. The goal is to better understand how healthcare professionals, including OTs, can support women during this transition.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Christine Mulligan, OTD
- Telefonnummer: 5182105086
- E-post: mullic@sage.edu
Studiesteder
-
-
New York
-
Troy, New York, Forente stater, 12180
- Russell Sage College
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Women aged 40-55
- Self-reported perimenopausal symptoms
- Currently employed (paid or unpaid) or managing household roles
- English-speaking
Exclusion Criteria:
- Surgical menopause
- Current pregnancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Women
Women aged 40-55 with self-reported perimenopausal symptoms, who are surrently employed (paid or unpaid) or managing household roles and are English-speaking.
|
Participants who consent to participate will complete confidential surveys and one voluntary interview.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Occupational Balance Questionnaire (OBQ-11)
Tidsramme: Baseline
|
An 11-item, self-report instrument developed to assess perceived occupational balance.
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Menopause-Specific Quality of Life Questionnaire (MENQOL)
Tidsramme: Baseline
|
A validated self-report tool designed to assess the impact of menopausal symptoms on health-related quality of life.
It consists of 29 items across four domains
|
Baseline
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue
Tidsramme: Baseline
|
Measures fatigue and its effects on daily functioning, including frequency, intensity, duration, and impact on physical, cognitive, and social activities.
|
Baseline
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Semi-structured interview
Tidsramme: Baseline
|
Participants who voluntarily agree to be contacted with high symptom severity will consent to a confidential semi-structured interview.
|
Baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Christine Mulligan, Russell Sage College
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
Andre studie-ID-numre
- RussellSage2
Plan for individuelle deltakerdata (IPD)
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