An interventional study of Sleep Hygiene Training in Women in the Menopausal Period, sponsored by Saglik Bilimleri Universitesi. Completed at 2 sites in Turkey (Türkiye). Open to female participants aged 40 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care
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.
Menopause is a significant stage in a woman's life characterized by the permanent cessation of menstruation and marked by substantial physiological, psychological, and social changes. It occurs as a result of decreased estrogen levels and increased follicle-stimulating hormone (FSH), with an average onset around the age of 51. During this period, women may experience a wide range of symptoms, including vasomotor complaints (hot flashes and night sweats), vaginal dryness, weight gain, skin changes, osteoporosis, and psychological disturbances. The severity and duration of these symptoms vary among individuals and may significantly affect daily functioning and quality of life.
Among these symptoms, sleep disturbances are one of the most prevalent and impactful problems during the menopausal transition. Hormonal changes, particularly the decline in estrogen and progesterone levels, disrupt serotonin and melatonin regulation, which play critical roles in sleep initiation and maintenance. As a result, menopausal women frequently experience insomnia, difficulty falling asleep, frequent awakenings, and reduced sleep quality. Studies indicate that 40-60% of perimenopausal and postmenopausal women report sleep-related problems, which may persist over time and lead to adverse health outcomes such as cardiovascular disease, diabetes, depression, and anxiety.
Sleep is a dynamic and essential physiological process necessary for maintaining physical and mental health. It is regulated by complex neurological mechanisms involving the Reticular Activating System (RAS) and Bulbar Synchronizing System (BSR), and consists of two main stages: non-rapid eye movement (NREM) and rapid eye movement (REM) sleep. NREM sleep accounts for the majority of total sleep and is associated with restorative processes, whereas REM sleep is linked to cognitive functions such as memory consolidation and emotional regulation. Disruptions in these sleep stages can impair overall health and well-being.
Sleep quality is influenced by various factors, including age, lifestyle, psychological stress, diet, environmental conditions, and existing health problems. In menopausal women, additional factors such as hormonal fluctuations, increased stress levels, and changes in daily routines further contribute to sleep disturbances. Poor sleep quality is associated with metabolic disorders, impaired immune function, reduced cognitive performance, and decreased quality of life.
Sleep hygiene refers to behavioral and environmental practices that promote healthy sleep patterns and improve sleep quality. It is a non-pharmacological, cost-effective, and widely recommended approach for managing sleep disturbances. Sleep hygiene includes regulating the sleep environment, maintaining consistent sleep schedules, engaging in regular physical activity, adopting healthy dietary habits, and improving mental control strategies.
Environmental factors such as room temperature, light exposure, and noise levels play a crucial role in sleep quality. Excessive light exposure, particularly from electronic devices, suppresses melatonin secretion and delays sleep onset. Similarly, noise and uncomfortable sleep conditions can disrupt sleep continuity. Maintaining a dark, quiet, and comfortable sleeping environment is therefore essential for optimal sleep.
Regular sleep timing is another critical component of sleep hygiene. Going to bed and waking up at consistent times helps regulate the circadian rhythm, improves sleep efficiency, and reduces daytime fatigue. Irregular sleep patterns, which are common during menopause, are associated with increased risk of insomnia and poor sleep quality.
Daily activities such as physical exercise also influence sleep. Moderate aerobic exercise has been shown to improve sleep duration and quality, reduce anxiety, and enhance overall well-being. However, intense physical activity immediately before bedtime may negatively affect sleep onset.
Dietary habits play a significant role in sleep regulation. Consumption of caffeine, alcohol, and nicotine can interfere with sleep quality by stimulating the central nervous system or disrupting sleep cycles. Additionally, late-night eating and high-calorie diets are associated with poor sleep and metabolic disturbances. In contrast, balanced nutrition and maintaining a healthy body weight contribute positively to sleep quality.
Psychological factors such as stress and anxiety are also strongly associated with sleep disturbances. Increased activation of the hypothalamic-pituitary-adrenal axis can impair sleep initiation and continuity. Relaxation techniques, breathing exercises, and stress management strategies have been shown to improve sleep outcomes and reduce insomnia symptoms.
Kolcaba's Comfort Theory provides a holistic framework for addressing patient needs by focusing on physical, psychospiritual, sociocultural, and environmental dimensions of comfort. According to this theory, comfort is a desired outcome of nursing care and is achieved through relief, ease, and transcendence. Addressing unmet comfort needs enhances patient well-being, supports recovery, and improves quality of life.
In the context of menopause, sleep hygiene education based on Comfort Theory offers a comprehensive and holistic approach. By addressing multiple dimensions of comfort, nurses can develop individualized interventions that target both physiological and psychosocial factors affecting sleep. This approach not only improves sleep quality but also enhances overall well-being and adaptation during the menopausal transition.
126 studies on the registry are indexed under Sleep Hygiene; 32 are open to participants now.
This study's enrollment of 60 is close to the median of 66 across 113 interventional studies indexed under Sleep Hygiene.
Browse Sleep Hygiene studies →Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: 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.
Time frame: Through study completion, an average of 6 months
Plan to share: No
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