Women in the Menopausal PeriodNCT06884917
Effect of Sleep Hygiene Education on Comfort and Sleep Quality in Menopausal Women
A study testing Sleep Hygiene Training in people with Women in the Menopausal Period, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Women in the Menopausal Period
- What is being tested?
- Sleep Hygiene Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sağlık Bilimleri Ünversitesi
Istanbul, Türkiye
Sağlık Bilimleri Ünversitesi
Istanbul
About this study
Official title: The Effect of Sleep Hygiene Education Based on the Comfort Theory of Kolcaba Given to Menopausal Women on Comfort Behaviors and Sleep Quality
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Women in the Menopausal Period
- Being tested
- Sleep Hygiene Training
- Keywords
- Comfort, Menopause, Sleep Hygiene, Sleep Quality
- Medical subject headings
- Sleep Hygiene, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Feb 2025
- Primary completion1 Oct 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women in the Menopausal PeriodStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beyzanur İşbay Aydemir, Msc, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884917
- Sponsor's protocol ID
- 211002081
- Status last verified
- Feb 2025
- First submitted
- 13 Mar 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Hygiene Education Based on the Comfort Theory of Kolcaba Given to Menopausal Women on Comfort Behaviors and Sleep Quality
- ClinicalTrials.gov ID
- NCT06884917
- Acronym / sponsor ID
- 211002081
- Conditions
- Women in the Menopausal Period
- Keywords
- Comfort, Menopause, Sleep Hygiene, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Training | Experimental | Other: Sleep Hygiene TrainingWomen 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. |
| 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. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Hygiene TrainingWritten 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. | Other | Sleep Hygiene Training |
Primary outcome
General Comfort Scale (GCS)
Time frame: Through study completion, an average of 6 months
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.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Through study completion, an average of 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beyzanur İşbay Aydemir, Msc study director
Saglik Bilimleri Universitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Hygiene Training in people with Women in the Menopausal Period, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Comfort Scale (GCS) (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.