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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06884917 on ClinicalTrials.gov