PerimenopauseNCT07570732
Occupational Disruption and Role Strain During Perimenopause
An observational study of Perimenopause, run by Russell Sage College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Perimenopause
- What is being tested?
- Confidential Surveys
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Women aged 40-55
- Self-reported perimenopausal symptoms
- Currently employed (paid or unpaid) or managing household roles
- English-speaking
Who cannot join
- Surgical menopause
- Current pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Occupational Disruption and Role Strain During Perimenopause: A Mixed-Methods Study
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.
Read the 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.
- Conditions
- Perimenopause
- Being tested
- Confidential Surveys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confidential SurveysOther
Participants who consent to participate will complete confidential surveys and one voluntary interview.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Confidential Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Balance Questionnaire (OBQ-11)
An 11-item, self-report instrument developed to assess perceived occupational balance.
Measured: Baseline
Secondary outcomes (2)
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
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russell Sage College
- Sponsor type
- University, hospital or other
- Collaborators
- Binghamton University
- Responsible party
- Principal investigator, Christine Mulligan, Russell Sage College
- Investigators
- Christine Mulligan, Principal investigator, Russell Sage College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570732
- Sponsor's protocol ID
- RussellSage2
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Disruption and Role Strain During Perimenopause: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07570732
- Acronym / sponsor ID
- RussellSage2
- Conditions
- Perimenopause
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Russell Sage CollegeUniversity, hospital or other
- Collaborators
- Binghamton University
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women | – | Other: Confidential SurveysWomen aged 40-55 with self-reported perimenopausal symptoms, who are surrently employed (paid or unpaid) or managing household roles and are English-speaking. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Women aged 40-55
- Self-reported perimenopausal symptoms
- Currently employed (paid or unpaid) or managing household roles
- English-speaking
Key exclusion criteria (2 listed)
- Surgical menopause
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Confidential SurveysParticipants who consent to participate will complete confidential surveys and one voluntary interview. | Other | Women |
Primary outcome
Occupational Balance Questionnaire (OBQ-11)
Time frame: Baseline
An 11-item, self-report instrument developed to assess perceived occupational balance.
2 secondary outcomes
Menopause-Specific Quality of Life Questionnaire (MENQOL)
Time frame: Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Perimenopause
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
Nutritional Supplementation on Physiological and Metabolic Markers in Females
Perimenopausal Women, Body Composition Changes
Recruiting
Exercise in Perimenopause to Improve Cognitive Health
Perimenopause, Subjective Cognitive Complaints
Recruiting
Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women
Perimenopause, Postmenopause
Not yet recruiting
Evaluation of the Effects of Lifestyle Medicine and Mindfulness-based Group Medical Visits on Stress, Microbiome, and Quality of Life in Women Experiencing Perimenopause and Menopause
Perimenopause, Menopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Mulligan principal investigator
Russell Sage College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perimenopause, run by Russell Sage College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Mulligan, OTD (5182105086, mullic@sage.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupational Balance Questionnaire (OBQ-11) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.