- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07570732
Occupational Disruption and Role Strain During Perimenopause
Occupational Disruption and Role Strain During Perimenopause: A Mixed-Methods Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christine Mulligan, OTD
- Phone Number: 5182105086
- Email: mullic@sage.edu
Study Locations
-
-
New York
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Troy, New York, United States, 12180
- Russell Sage College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occupational Balance Questionnaire (OBQ-11)
Time Frame: Baseline
|
An 11-item, self-report instrument developed to assess perceived occupational balance.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Menopause-Specific Quality of Life Questionnaire (MENQOL)
Time Frame: 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
Time Frame: Baseline
|
Measures fatigue and its effects on daily functioning, including frequency, intensity, duration, and impact on physical, cognitive, and social activities.
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semi-structured interview
Time Frame: Baseline
|
Participants who voluntarily agree to be contacted with high symptom severity will consent to a confidential semi-structured interview.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Mulligan, Russell Sage College
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RussellSage2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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