Effect of Sleep Hygiene Education on Comfort and Sleep Quality in Menopausal Women
NCT06884917 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-04-13
Summary
The decrease in estrogen levels in the body during menopause can lead to sleep disturbances by disrupting serotonin metabolism, which plays an important role in regular sleep. Considering the increase in life expectancy, the duration of time women will spend in menopause is also increasing, making the understanding of menopause physiology and potential management strategies highly important for women's health.
One of the most important factors in managing insomnia is sleep hygiene. Sleep hygiene is defined as the principles and practices that improve sleep quality. Additionally, during menopause, using the comfort theory to recognize unmet comfort needs, collecting data on these needs, providing interventions, and ensuring the individual's comfort at the highest level are responsibilities of the nurse. To achieve this, the nurse needs to determine the individual's comfort level before providing care, then assess their physical, psychosocial, sociocultural, and environmental comfort needs as a whole.
This research is designed as a randomized pre-test post-test control group study to evaluate the impact of Kolcaba's comfort theory-based sleep hygiene education on comfort behaviors and sleep quality in menopausal women. The research will be conducted between July and December 2024 at Zeynep Kâmil Women's and Children's Diseases Training and Research Hospital, Gynecology Outpatient Clinic, in Istanbul. The study population will consist of menopausal women who visit the Gynecology Outpatient Clinic. The sample will include premenopausal women who meet the inclusion criteria for the study. The sample size in the study was planned to be 60 (intervention group = 30, control group = 30), calculated using the G Power version 3.1 program with α = 0.05, 1-β = 0.95, and effect size = 1.00, considering the possibility of sample loss.
Data will be collected using the "Personal Information Form (Appendix-1)", "General Comfort Scale (Appendix-2)", and "Pittsburgh Sleep Quality Index (Appendix-3)". The data will be analyzed using SPSS 22.0 software.
A total of three sessions will be conducted with each woman, with each session lasting 60 minutes. The intervals between sessions will be arranged as two weeks between the first and second sessions, and eight weeks between the second and third sessions. The first measurement will be taken before the first session, and the final measurement will be taken after the third session.
Conditions
- Women in the Menopausal Period
Interventions
- OTHER
-
Sleep Hygiene Training
Written consent will be obtained from the women, and a Personal Information Form will be applied. The General Comfort Scale (GCS) will be applied to the women. The Pittsburgh Sleep Quality Index (PSQI) will be applied to the women. Each level will include the physical, socio-cultural, psycho-spiritual, and environmental dimensions where the requirements to ensure comfort arise.
Sponsors & Collaborators
-
Saglik Bilimleri Universitesi
lead OTHER
Principal Investigators
-
Beyzanur İşbay Aydemir, Msc · Saglik Bilimleri Universitesi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-01
- Primary Completion
- 2025-10-01
- Completion
- 2026-03-30
Countries
- Turkey (Türkiye)
Study Locations
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