The Effect of Sleep Hygiene Education Based on the Comfort Theory of Kolcaba Given to Menopausal Women on Comfort Behaviors and Sleep Quality

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 50
Healthy Volunteers: f
View:

• Voluntarily agree to participate in the study, Are literate, Are open to communication and cooperation, Score 5 or higher on the Pittsburgh Sleep Quality Index (PSQI), Have a Body Mass Index (BMI) lower than 30 kg/m², Have one or more of the following symptoms: vasomotor symptoms such as hot flashes and night sweats, menstrual irregularities, vaginal dryness, urinary incontinence, or sleep disturbances, Are in the premenopausal period and have consulted the gynecology outpatient clinic.

Locations
Other Locations
Turkey
Sağlık Bilimleri Ünversitesi
RECRUITING
Istanbul
Sağlık Bilimleri Ünversitesi
NOT_YET_RECRUITING
Istanbul
Contact Information
Primary
Beyzanur İşbay Aydemir, Msc
bisbay94@hotmail.com
+905456078994
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 60
Treatments
Experimental: Sleep Hygiene Training
Women who will participate in the Sleep Hygiene Education based on Comfort Theory (intervention group) will have face-to-face meetings in the meeting rooms of Zeynep Kâmil Women's and Children's Diseases Training and Research Hospital. The date and time of the meetings will be scheduled according to the women's availability and they will be contacted a day before the scheduled training day as a reminder. If the women do not attend the appointment, a new appointment will be scheduled for another day. A total of three meetings will be held with each woman, each lasting 60 minutes. Looking at the intervals between the meetings; the first and second sessions will have a two-week gap, and there will be an eight-week gap between the second and third sessions. The first measurement will be taken before the first meeting, and the final measurement will be conducted after the third meeting. After the second meeting, a brochure on sleep hygiene will be provided.
No_intervention: Observation
The control group will be given the first measurement before the first interview of the intervention group and the last measurement after the third interview of the intervention group. The control group will be given a brochure on sleep hygiene after the third interview.
Related Therapeutic Areas
Sponsors
Leads: Saglik Bilimleri Universitesi

This content was sourced from clinicaltrials.gov

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