Occupational Disruption and Role Strain During Perimenopause | NCT07570732

Studies
Occupational Disruption and Role Strain During Perimenopause

NCT07570732

Sponsor

Russell Sage College

Status

Not yet recruiting

Last Update Posted

May 6, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Perimenopause

Interventions

Confidential Surveys

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

May 1, 2027Estimated

First Submitted Date

Apr 26, 2026

First Submission Date that Met QC Criteria

May 1, 2026

First Posted Date

May 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2026

Last Update Posted Date

May 6, 2026Actual

Name	Class
Binghamton University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Confidential Surveys	Other	Participants who consent to participate will complete confidential surveys and one voluntary interview.	Women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occupational Balance Questionnaire (OBQ-11)	An 11-item, self-report instrument developed to assess perceived occupational balance.	Baseline

Secondary Outcomes

Measure	Description	Time Frame
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	Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue

Other Outcomes

Measure	Description	Time Frame
Semi-structured interview	Participants who voluntarily agree to be contacted with high symptom severity will consent to a confidential semi-structured interview.	Baseline

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Born a female

Minimum Age

40 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christine Mulligan, OTD	Contact	5182105086		mullic@sage.edu

Overall Officials

Name	Affiliation	Role
Christine Mulligan	Russell Sage College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Russell Sage College		Troy	New York	12180	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided