Sleep and Quality of Life Among Postmenopausal Women

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05634668

Collaborator

(none)

320

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance Postmenopausal Symptoms	Other: Interviewing sheet

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 Design

Study Type:

Observational

Anticipated Enrollment :

320 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Outcome Measures

Primary Outcome Measures

The menopausal quality of life score [one hour]
scoring the menopausal symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Amira Rashad Youssef Soliman, Principal Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05634668

Other Study ID Numbers:

Menopausal Sleep disturbance

First Posted:

Dec 2, 2022

Last Update Posted:

Dec 2, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyssomnias

Parasomnias

Study Results

No Results Posted as of Dec 2, 2022