Occupational Disruption and Role Strain During Perimenopause

ConditionPerimenopause

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age40-55

SponsorRussell Sage College

About this trial

The purpose of this sequential exploratory mixed-methods study is to examine the relationship between perimenopausal symptom severity and occupational performance, occupational balance, and role participation in women aged 40-55. A secondary purpose is to explore the lived experience of occupational disruption during perimenopause through qualitative interviews.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 40-55

Self-reported perimenopausal symptoms

Currently employed (paid or unpaid) or managing household roles

English-speaking

Disqualifiers

Surgical menopause

Current pregnancy

Trial population

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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Confidential Surveys
Other intervention
Participants who consent to participate will complete confidential surveys and one voluntary interview.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Women1 intervention

Trial outcomes

Primary outcomes

Occupational Balance Questionnaire (OBQ-11)

An 11-item, self-report instrument developed to assess perceived occupational balance.

Time frame

Baseline

Secondary outcomes

Menopause-Specific Quality of Life Questionnaire (MENQOL)

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

Time frame

Baseline

Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue

Measures fatigue and its effects on daily functioning, including frequency, intensity, duration, and impact on physical, cognitive, and social activities.

Time frame

Baseline

Other outcomes

Semi-structured interview

Participants who voluntarily agree to be contacted with high symptom severity will consent to a confidential semi-structured interview.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Russell Sage College

Lead sponsor

Binghamton University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: