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NCT Number: NCT07570732

Occupational Disruption and Role Strain During Perimenopause

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.

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Key information

Conditions

Age range

40 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Russell Sage College

Troy, New York, 12180, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Confidential Surveys

Other

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

Primary outcomes

  1. Occupational Balance Questionnaire (OBQ-11)

    Time frame: Baseline

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

Secondary outcomes

  1. 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

  2. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Mulligan, OTD

CONTACT

[email protected]

5182105086

Sponsors and collaborators

Lead sponsor

Russell Sage College

Other

Collaborators

  • Binghamton University

Registry information

Official study title

Occupational Disruption and Role Strain During Perimenopause: A Mixed-Methods Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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