Clinical trial NCT05634668: Sleep and Quality of Life Among Postmenopausal Women
Official title: Study of Sleep Disturbances and Quality of Life Among Postmenopausal Women: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disturbance
Postmenopausal Symptoms
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 320
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The menopausal quality of life score
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University, Assiut, Egypt
name: Amira Ra Youssef Soliman, Resident
role: PRINCIPAL_INVESTIGATOR
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