Sleep and Quality of Life Among Postmenopausal Women

NCT05634668 | Unknown

• 1 other identifier: Menopausal Sleep disturbance
• Study Type: observational
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Sleep Disturbance; Postmenopausal Symptoms

Outcome Measures

Primary Outcomes (1)

• The menopausal quality of life score

  scoring the menopausal symptoms

  one hour

Interventions

Interviewing sheet OTHER

1. . 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. 2. . 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 3. . 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.

Also known as: Menopause specific quality of life questionnaire (MENQOL), Pittsburgh Sleep Quality Index (PSQI)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (18)

• 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.

  PMID: 31378291 BACKGROUND

• Gozuyesil E, Gokyildiz Surucu S, Alan S. Sexual function and quality-of-life-related problems during the menopausal period. J Health Psychol. 2018 Dec;23(14):1769-1780. doi: 10.1177/1359105317742194. Epub 2017 Dec 15.

  PMID: 29243521 BACKGROUND

• 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.

  PMID: 31706430 BACKGROUND

• 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.

  PMID: 27545107 BACKGROUND

• AlDughaither A, AlMutairy H, AlAteeq M. Menopausal symptoms and quality of life among Saudi women visiting primary care clinics in Riyadh, Saudi Arabia. Int J Womens Health. 2015 Jun 29;7:645-53. doi: 10.2147/IJWH.S84709. eCollection 2015.

  PMID: 26170720 BACKGROUND

• 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.

  PMID: 31533486 BACKGROUND

• 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.

  PMID: 30294188 BACKGROUND

• 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.

  PMID: 31032743 BACKGROUND

• 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.

  PMID: 30098758 BACKGROUND

• 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.

  PMID: 23615642 BACKGROUND

• 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.

  PMID: 21961720 BACKGROUND

• 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.

  PMID: 24800878 BACKGROUND

• Ali AM, Ahmed AH, Smail L. Psychological Climacteric Symptoms and Attitudes toward Menopause among Emirati Women. Int J Environ Res Public Health. 2020 Jul 13;17(14):5028. doi: 10.3390/ijerph17145028.

  PMID: 32668726 BACKGROUND

• 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.

  PMID: 28141665 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.

  PMID: 8844630 BACKGROUND

• 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.

  PMID: 19915205 BACKGROUND

• 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.

  PMID: 29806589 BACKGROUND

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Amira Ra Youssef Soliman, Resident

  Assiut University, Assiut, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira Ra Youssef Soliman, Resident

CONTACT

+201011239241; amirarashad074@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: December 2, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: December 2, 2022

Record last verified: 2022-11