NCT07570732

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

April 26, 2026

Last Update Submit

May 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occupational Balance Questionnaire (OBQ-11)

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

    Baseline

Secondary Outcomes (2)

  • Menopause-Specific Quality of Life Questionnaire (MENQOL)

    Baseline

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue

    Baseline

Other Outcomes (1)

  • Semi-structured interview

    Baseline

Study Arms (1)

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.

Other: Confidential Surveys

Interventions

Participants who consent to participate will complete confidential surveys and one voluntary interview.

Women

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBorn a female
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • Women aged 40-55
  • Self-reported perimenopausal symptoms
  • Currently employed (paid or unpaid) or managing household roles
  • English-speaking

You may not qualify if:

  • Surgical menopause
  • Current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Russell Sage College

Troy, New York, 12180, United States

Location

Study Officials

  • Christine Mulligan

    Russell Sage College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Mulligan, OTD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2026

First Posted

May 6, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations