Sleep and Quality of Life Among Postmenopausal Women

NCT ID: NCT05634668

Last Updated: 2022-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Disturbance Postmenopausal Symptoms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interviewing sheet

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Menopause specific quality of life questionnaire (MENQOL) Pittsburgh Sleep Quality Index (PSQI)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amira Rashad Youssef Soliman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amira Ra Youssef Soliman, Resident

Role: PRINCIPAL_INVESTIGATOR

Assiut University, Assiut, Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amira Ra Youssef Soliman, Resident

Role: CONTACT

+201011239241

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31378291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29243521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31706430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27545107 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26170720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31533486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30294188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31032743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30098758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23615642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21961720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24800878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32668726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28141665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8844630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19915205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29806589 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Menopausal Sleep disturbance

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Self-Management of Sleep Among Older Adults
NCT03837249 COMPLETED EARLY_PHASE1
Sleep Health Enhancement in Midlife Adults
NCT06311500 COMPLETED PHASE1/PHASE2