Sleep and Quality of Life Among Postmenopausal Women

November 23, 2022 updated by: Amira Rashad Youssef Soliman, Assiut University

Study of Sleep Disturbances and Quality of Life Among Postmenopausal Women: A Cross-sectional Study

The purpose of this study is to assess the sleep quality and quality of life of the study population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Natural menopause can be defined as the cessation of menses for twelve sequential months without physiological or pathologic causes, referring to the end of a woman's reproductive capability. There is considerable variation in reporting of menopausal symptoms by women all over the world in different studies. The most common psychological symptoms was physical, mental exhaustion and Sleep disturbances. Sleep quality is affected poorly during the menopausal transition, and 40-60% of menopausal women are suffering from sleep disturbances. The causes for sleep disorders in postmenopausal women can be divided broadly into psychological and physical. However, changes in sleep patterns after menopause are frequently the result of physical factors. Sleep quality and its effect on quality of life among postmenopausal women is vital topic and the previous Literatures in this topic are deficient. So, there is a need to study sleep quality and quality of life particularly in our population where women are less aware about menopausal symptoms.

Study Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women will be recruited from the postmenopausal population presenting to the outpatient clinics or admitted to the inpatient wards at Assiut University Hospital and their female relatives who are between 45 and 70 years of age. A woman is defined as postmenopausal if 12 months had passed after her last menstruation. Meanwhile, we will exclude women with induced menopause, who underwent a simple hysterectomy, who is currently receiving hormonal therapy, and who has medical conditions such as diabetes, hypertension, cardiac disease, and thyroid disorders, as these may mislead our results. Additionally, women who refuses to participate in this study will be excluded

Description

Inclusion Criteria:

  • Postmenopausal women aged 45-70 years, married, who experienced natural menopause confirmed by menstrual cessation for at least one year or a FSH level ≥40 IU/L .

Exclusion Criteria:

  • women who

    1. single, widow or divorced.
    2. had an induced menopause
    3. underwent simple hysterectomy .
    4. receiving any kind of hormone therapy, antidepressants, or antipsychotics .
    5. had medical conditions such as diabetes, hypertension, cardiac disease, and thyroid disorders .
    6. had experienced any stressful events during the past year or had depressive disorders as they can mislead our results
    7. Patient refused to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The menopausal quality of life score
Time Frame: one hour
scoring the menopausal symptoms
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Amira Ra Youssef Soliman, Resident, Assiut University, Assiut, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Menopausal Sleep disturbance

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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