- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07570732
Occupational Disruption and Role Strain During Perimenopause
Occupational Disruption and Role Strain During Perimenopause: A Mixed-Methods Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Christine Mulligan, OTD
- Telefonnummer: 5182105086
- E-post: mullic@sage.edu
Studieorter
-
-
New York
-
Troy, New York, Förenta staterna, 12180
- Russell Sage College
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Occupational Balance Questionnaire (OBQ-11)
Tidsram: Baseline
|
An 11-item, self-report instrument developed to assess perceived occupational balance.
|
Baseline
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Menopause-Specific Quality of Life Questionnaire (MENQOL)
Tidsram: 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
Tidsram: Baseline
|
Measures fatigue and its effects on daily functioning, including frequency, intensity, duration, and impact on physical, cognitive, and social activities.
|
Baseline
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Semi-structured interview
Tidsram: Baseline
|
Participants who voluntarily agree to be contacted with high symptom severity will consent to a confidential semi-structured interview.
|
Baseline
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Christine Mulligan, Russell Sage College
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- RussellSage2
Plan för individuella deltagardata (IPD)
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