Sleep and Quality of Life Among Postmenopausal Women

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05634668
• Other study ID #: Menopausal Sleep disturbance
• Status: Not yet recruiting
• Start date: December 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: Amira Ra Youssef Soliman, Resident
• Phone: +201011239241
• Email: amirarashad074[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: January 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women aged 45-70 years, married, who experienced natural menopause con?rmed 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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Postmenopausal Symptoms
• Sleep Disturbance

Intervention

Other:
• Interviewing sheet
. Interviewing sheet: It was designed by the researchers and used to obtain subjects' sociodemographic data; their age, menopausal age, gravidity, parity, BMI, residency, occupation, education level, hot flashes, sweating, and daily habits. . Menopause specific quality of life questionnaire (MENQOL): MENQOL was designed by Hilditch and used to assess the presence of menopausal symptoms, its severity, and the degree to which they adversely affect women's life. It consisted of 29 items categorized into four domains . Pittsburgh Sleep Quality Index (PSQI): The PSQI was a self-report scale consisting of 7 components and 19 questions. PSQI studies quality of sleep in the recent month.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (18)

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Baker FC, Lampio L, Saaresranta T, Polo-Kantola P. Sleep and Sleep Disorders in the Menopausal Transition. Sleep Med Clin. 2018 Sep;13(3):443-456. doi: 10.1016/j.jsmc.2018.04.011. Review. — View Citation

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Ibrahim ZM, Ghoneim HM, Madny EH, Kishk EA, Lotfy M, Bahaa A, Taha OT, Aboelroose AA, Atwa KA, Abbas AM, Mohamed ASI. The effect of menopausal symptoms on the quality of life among postmenopausal Egyptian women. Climacteric. 2020 Feb;23(1):9-16. doi: 10.1080/13697137.2019.1656185. Epub 2019 Sep 19. — View Citation

Khatoon A, Husain S, Husain S, Hussain S. An Overview of Menopausal Symptoms Using the Menopause Rating Scale in a Tertiary Care Center. J Midlife Health. 2018 Jul-Sep;9(3):150-154. doi: 10.4103/jmh.JMH_31_18. — View Citation

Kling JM, Kelly M, Rullo J, Kapoor E, Kuhle CL, Vegunta S, Mara KC, Faubion SS. Association between menopausal symptoms and relationship distress. Maturitas. 2019 Dec;130:1-5. doi: 10.1016/j.maturitas.2019.09.006. Epub 2019 Sep 16. — View Citation

Kling JM, Manson JE, Naughton MJ, Temkit M, Sullivan SD, Gower EW, Hale L, Weitlauf JC, Nowakowski S, Crandall CJ. Association of sleep disturbance and sexual function in postmenopausal women. Menopause. 2017 Jun;24(6):604-612. doi: 10.1097/GME.0000000000000824. — View Citation

Kravitz HM, Joffe H. Sleep during the perimenopause: a SWAN story. Obstet Gynecol Clin North Am. 2011 Sep;38(3):567-86. doi: 10.1016/j.ogc.2011.06.002. — View Citation

Li CC, Tsai YF, Chang TC, Chen L. Associations among menopausal symptoms, sleep and fatigue in Taiwanese women with endometrial cancer. Eur J Cancer Care (Engl). 2017 Sep;26(5). doi: 10.1111/ecc.12559. Epub 2016 Aug 21. — View Citation

Minkin MJ. Menopause: Hormones, Lifestyle, and Optimizing Aging. Obstet Gynecol Clin North Am. 2019 Sep;46(3):501-514. doi: 10.1016/j.ogc.2019.04.008. Epub 2019 Jun 21. Review. — View Citation

Moudi A, Dashtgard A, Salehiniya H, Sadat Katebi M, Reza Razmara M, Reza Jani M. The relationship between health-promoting lifestyle and sleep quality in postmenopausal women. Biomedicine (Taipei). 2018 Jun;8(2):11. doi: 10.1051/bmdcn/2018080211. Epub 2018 May 28. — View Citation

Suleiman KH, Yates BC, Berger AM, Pozehl B, Meza J. Translating the Pittsburgh Sleep Quality Index into Arabic. West J Nurs Res. 2010 Mar;32(2):250-68. doi: 10.1177/0193945909348230. Epub 2009 Nov 14. — View Citation

Tadayon M, Ilkhani M, Abedi P, Haghighi Zadeh M. The relationship between sleep quality and lifestyle in postmenopausal Iranian women: a cross-sectional study. Women Health. 2019 Sep;59(8):883-891. doi: 10.1080/03630242.2019.1607802. Epub 2019 Apr 28. — View Citation

Weber MT, Rubin LH, Maki PM. Cognition in perimenopause: the effect of transition stage. Menopause. 2013 May;20(5):511-7. doi: 10.1097/GME.0b013e31827655e5. — View Citation

Xu Q, Lang CP. Examining the relationship between subjective sleep disturbance and menopause: a systematic review and meta-analysis. Menopause. 2014 Dec;21(12):1301-18. doi: 10.1097/GME.0000000000000240. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The menopausal quality of life score	scoring the menopausal symptoms	one hour