Effect of Sleep Hygiene Education on Comfort and Sleep Quality in Menopausal Women

NCT06884917 | Completed

• 1 other identifier: 211002081
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Comfort; Menopause; Sleep Hygiene; Sleep Quality

Outcome Measures

Primary Outcomes (2)

• General Comfort Scale (GCS)

  The General Comfort Scale was developed by Kolcaba in 1992. It is used to assess the increase in comfort expected from nursing interventions that promote comfort by identifying individual needs. The scale is a four-point Likert type and contains a total of 48 items. The scale consists of both positive and negative items, with the response patterns mixed. In this regard, a high score (4) on positive items indicates high comfort, and a low score (1) indicates low comfort. In the evaluation of the scale, the negative scores are reverse-coded and summed with the positive items. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. The Turkish validity and reliability of the scale were conducted by Kuğuoğlu and Karabacak in 2004. In the internal consistency analysis of the scale, Kuğuoğlu and Karabacak (2008) found the Cronbach's Alpha coefficient to be 0.85 and reported that the scale has high reliability.

  Through study completion, an average of 6 months

• Pittsburgh Sleep Quality Index (PSQI)

  The PSQI was developed by Buysse and colleagues in 1989. The validity and reliability study of the PSQI was conducted by Ağargün and colleagues in 1996, and the Cronbach Alpha value was calculated to be 0.79. The PSQI is a self-report scale that evaluates sleep quality and disturbances over a one-month period. The scale consists of seven subcomponents: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. It includes a total of 24 questions, with the first 19 questions answered by the individual, and the last five questions answered by the individual's bed partner or roommate. Each item in the scale is scored between 0 and 3, and the total score ranges from 0 to 21. Higher scores indicate poor sleep quality and a higher level of sleep disturbance. A total score of over five indicates clinically poor sleep quality.

  Through study completion, an average of 6 months

Study Arms (2)

Sleep Hygiene Training

EXPERIMENTAL

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.

Other: Sleep Hygiene Training

Observation

NO INTERVENTION

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.

Interventions

Sleep Hygiene Training OTHER

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.

Sleep Hygiene Training

Eligibility Criteria

• Age: 40 Years - 50 Years
• Gender Eligibility Details: Premenopausal women who present to the gynaecology outpatient clinic with one or more of the following symptoms: vasomotor symptoms such as hot flushes, night sweats, menstrual irregularities, urogenital symptoms such as vaginal dryness, urinary incontinence, sleep disorders such as disturbed sleep patterns.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed with a sleep disorder, Have a chronic illness, Are undergoing hormone replacement therapy, Use sleep-related medications such as melatonin, benzodiazepines, antihistamines, and barbiturates, Use alcohol or cigarettes.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (2)

Sağlık Bilimleri Ünversitesi

Istanbul, Türkiye, Turkey (Türkiye)

Location

Sağlık Bilimleri Ünversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Hygiene; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Beyzanur İşbay Aydemir, Msc

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: February 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: March 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)