Absence of Menstrual Bleeding for at Least 12 Consecutive MonthsNCT06991660
The Effect of Sleep Hygiene Education Given in Line With the Health Promotion Model on Sleep Quality and Menopause Symptoms
A study testing sleep hygiene education in people with Absence of Menstrual Bleeding for at Least 12 Consecutive Months and No Communication Difficulties, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Health promotion is defined as the behaviors that a person exhibits for a long-term and high-standard life. Health promotion creates a sense of health in the individual, which makes the person feel more energetic and happy. The health promotion model primarily aims to treat the disease in the person. Read more about this study
- Who is it for?
- Ages 45 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Absence of Menstrual Bleeding for at Least 12 Consecutive Months, No Communication Difficulties, Using a Mobile Phone
- What is being tested?
- sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 30 Jan 2025
- 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 45 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not having menstrual bleeding for at least 12 consecutive months
- Not having difficulty communicating
- Using a mobile phone
- Being literate
- Not using sleeping pills
- Not taking any supplements to sleep.
Who cannot join
- Menstrual bleeding during the research period
- The participant wants to talk about his/her research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sleep Hygiene Education Given in Line With the Health Promotion Model on Sleep Quality and Menopausal Symptoms
Health promotion is defined as the behaviors that a person exhibits for a long-term and high-standard life. Health promotion creates a sense of health in the individual, which makes the person feel more energetic and happy. The health promotion model primarily aims to treat the disease in the person. If the individual does not have a disease, their health is further improved. Sleep is one of the basic needs required for a person to continue their life in a healthy way. Some behaviors of people affect the quality and order of sleep. Sleep hygiene is the daily activities performed to improve the quality of sleep during sleep. Sleep hygiene education aims to avoid personal behaviors that affect a healthy sleep order and to exhibit behaviors that will positively affect sleep. Menopause is defined as the permanent cessation of the menstrual cycle as a result of the ovaries losing their activity. Menopause is one of the important stages of a woman's life. Some physical and psychological changes begin to occur in women who lose their fertility and enter menopause. These changes are generally called menopausal symptoms. These symptoms are; menstrual irregularity, hot flashes, sleep disorders, tension and depression, etc. The research was planned as an experimental pre-test and post-test, and the data will be collected before and after the face-to-face training given by the researcher. The effects of sleep hygiene training given in line with the health promotion model on sleep have been investigated in the literature, but no study has been found examining the effects of sleep hygiene training given in line with the health promotion model on sleep hygiene and menopausal symptoms of women in menopause. Therefore, it is thought that the research will contribute to the literature. The results obtained as a result of the study regarding the effects of sleep hygiene training given on sleep hygiene and menopausal symptoms will be taken into consideration by midwives.
- Conditions
- Absence of Menstrual Bleeding for at Least 12 Consecutive Months, No Communication Difficulties, Using a Mobile Phone, Becoming Literate, Not Using Sleeping Pills, Not Taking Any Supplements to Sleep
- Being tested
- sleep hygiene education
- Keywords
- menopause symptoms, midwife, sleep hygiene education, sleep quality, health promotion model
- Medical subject headings
- 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 educationBehavioural
This study will be conducted to examine the effects of sleep hygiene training, which is given to women in menopause to eliminate sleep problems and menopause symptoms that they often experience, on sleep and menopause symptoms experienced by women.
| Study group | Role | What they receive |
|---|---|---|
| training group | Experimental | First interview: This interview, which was held at the ASM, included meeting the women in the intervention group, applying the pre-test data, explaining the purpose of the training, and determining the training location (ASM, the participant's home, etc.).
Second interview: One week after the first interview, at the appointed location (ASM and the participant's home), the "Sleep Hygiene Training" prepared according to the individual characteristics - experiences and behavior-specific cognitive processes and behavioral outputs that are the components of the SGM was carried out, the "Sleep Diary" was introduced, the "Sleep Hygiene Training Booklet" and the "Sleep Diary" were distributed.
Third interview: One week after the second interview, the repeat training, which constitutes the second session of the training, was carried out.
Fourth interview: Obtaining the post-test data 4 weeks after the second interview.
The researcher reminded the participants about the sleep diary via text Receives: Behavioral: sleep hygiene education |
| control group | No intervention | A total of two interviews were conducted with women in the control group who were not given any intervention. In the first interview, pre-test data were obtained using the Personal Introduction Form, MSDS and PSQI. In the interview held 6 weeks after the first interview, post-test data were obtained using MSDS and PSQI. Each interview lasted an average of 15-20 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
It was developed by Buysse et al. (1989) to assess sleep quality. It was adapted to Turkish by Ağargün et al. in 1996. The PSQI assesses the quality of an individual's sleep in the last month. While the individual answers 19 of the 24 questions in the PSQI, 5 questions are expected to be answered by the spouse or a roommate. The last 5 questions are directed only to the individual's relative in terms of clinical aspects and are not included in the scoring. The last of the questions asked as self-report questions is whether the individual has a roommate or spouse; this question is not used in the evaluation of the PSQI. There are different factors related to sleep quality in the self-report questions. The 18 items included in the scoring are divided into groups as 7 component scores. Some of the components are shown with only one item, while the other results in the classification of several items. Each component in the questions is worth 0-3 points.
Measured: first day encountered
Menopausal Symptoms Assessment Scale
MSDÖ, developed by Schneider and colleagues in German to determine the level of menopause experienced by women, was translated and adapted into Turkish by Gürkan in 2005. The Likert-type scale consists of a total of 11 items covering menopausal complaints. Each item has three sub-dimensions, with the options 0: none at all, 1: mild, 2: moderate, 3: severe and 4: very severe. These are;
- Somatic symptoms sub-dimension: items 1, 2, 3, 11
- Psychological symptoms sub-dimension: items 4, 5, 6, 7
- Urogenital symptoms sub-dimension: items 8, 9, 10. The total score of the scale is calculated according to the scores given to each item. The lowest score on the scale is 0, and the highest score is 44. A high total score calculated at the end of the scale indicates that the participant has many complaints and that their standard of living is negatively affected.
Measured: first day encountered
Secondary outcomes (2)
pittsburg sleep index
It was developed by Buysse et al. (1989) to assess sleep quality. It was adapted to Turkish by Ağargün et al. in 1996. The PSQI assesses the quality of an individual's sleep in the last month. While the individual answers 19 of the 24 questions in the PSQI, 5 questions are expected to be answered by the spouse or a roommate. The last 5 questions are directed only to the individual's relative in terms of clinical aspects and are not included in the scoring. The last of the questions asked as self-report questions is whether the individual has a roommate or spouse; this question is not used in the evaluation of the PSQI. There are different factors related to sleep quality in the self-report questions. The 18 items included in the scoring are divided into groups as 7 component scores. Some of the components are shown with only one item, while the other results in the classification of several items. Each component in the questions is worth 0-3 points.
Measured: up to 4 weeks after registration
Menopausal Symptoms Assessment Scale
MSDÖ, developed by Schneider and colleagues in German to determine the level of menopause experienced by women, was translated and adapted into Turkish by Gürkan in 2005. The Likert-type scale consists of a total of 11 items covering menopausal complaints. Each item has three sub-dimensions, with the options 0: none at all, 1: mild, 2: moderate, 3: severe and 4: very severe. These are;
- Somatic symptoms sub-dimension: items 1, 2, 3, 11
- Psychological symptoms sub-dimension: items 4, 5, 6, 7
- Urogenital symptoms sub-dimension: items 8, 9, 10. The total score of the scale is calculated according to the scores given to each item. The lowest score on the scale is 0, and the highest score is 44. A high total score calculated at the end of the scale indicates that the participant has many complaints and that their standard of living is negatively affected.
Measured: up to 4 weeks after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Feb 2024
- Primary completion31 Mar 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absence of Menstrual Bleeding for at Least 12 Consecutive MonthsStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- First interview: This interview, which was held at the ASM, included meeting the women in the intervention group, applying the pre-test data, explaining the purpose of the training, and determining the training location (ASM, the participant's home, etc.). Second interview: One week after the first interview, at the appointed location (ASM and the participant's home), the "Sleep Hygiene Training" prepared according to the individual characteristics - experiences and behavior-specific cognitive processes and behavioral outputs that are the components of the SGM was carried out, the "Sleep Diary" was introduced, the "Sleep Hygiene Training Booklet" and the "Sleep Diary" were distributed. Third interview: One week after the second interview, the repeat training, which constitutes the second session of the training, was carried out. Fourth interview: Obtaining the post-test data 4 weeks after the second interview. The researcher reminded the participants about the sleep diary via text m
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Yıldırım, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991660
- Sponsor's protocol ID
- 2023/4984
- Status last verified
- Feb 2025
- First submitted
- 2 May 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD underlying results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Hygiene Education Given in Line With the Health Promotion Model on Sleep Quality and Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT06991660
- Acronym / sponsor ID
- 2023/4984
- Conditions
- Absence of Menstrual Bleeding for at Least 12 Consecutive Months, No Communication Difficulties, Using a Mobile Phone, Becoming Literate, Not Using Sleeping Pills, Not Taking Any Supplements to Sleep
- Keywords
- menopause symptoms, midwife, sleep hygiene education, sleep quality, health promotion model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 28 May 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.
Health promotion is defined as the behaviors that a person exhibits for a long-term and high-standard life. Health promotion creates a sense of health in the individual, which makes the person feel more energetic and happy. The health promotion model primarily aims to treat the disease in the person. If the individual does not have a disease, their health is further improved. Sleep is one of the basic needs required for a person to continue their life in a healthy way. Some behaviors of people affect the quality and order of sleep. Sleep hygiene is the daily activities performed to improve the quality of sleep during sleep. Sleep hygiene education aims to avoid personal behaviors that affect a healthy sleep order and to exhibit behaviors that will positively affect sleep. Menopause is defined as the permanent cessation of the menstrual cycle as a result of the ovaries losing their activity. Menopause is one of the important stages of a woman's life. Some physical and psychological changes begin to occur in women who lose their fertility and enter menopause. These changes are generally called menopausal symptoms. These symptoms are; menstrual irregularity, hot flashes, sleep disorders, tension and depression, etc. The research was planned as an experimental pre-test and post-test, and the data will be collected before and after the face-to-face training given by the researcher. The effects of sleep hygiene training given in line with the health promotion model on sleep have been investigated in the literature, but no study has been found examining the effects of sleep hygiene training given in line with the health promotion model on sleep hygiene and menopausal symptoms of women in menopause. Therefore, it is thought that the research will contribute to the literature. The results obtained as a result of the study regarding the effects of sleep hygiene training given on sleep hygiene and menopausal symptoms will be taken into consideration by midwives.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First interview: This interview, which was held at the ASM, included meeting the women in the intervention group, applying the pre-test data, explaining the purpose of the training, and determining the training location (ASM, the participant's home, etc.). Second interview: One week after the first interview, at the appointed location (ASM and the participant's home), the "Sleep Hygiene Training" prepared according to the individual characteristics - experiences and behavior-specific cognitive processes and behavioral outputs that are the components of the SGM was carried out, the "Sleep Diary" was introduced, the "Sleep Hygiene Training Booklet" and the "Sleep Diary" were distributed. Third interview: One week after the second interview, the repeat training, which constitutes the second session of the training, was carried out. Fourth interview: Obtaining the post-test data 4 weeks after the second interview. The researcher reminded the participants about the sleep diary via text m
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Behavioral: sleep hygiene educationFirst interview: This interview, which was held at the ASM, included meeting the women in the intervention group, applying the pre-test data, explaining the purpose of the training, and determining the training location (ASM, the participant's home, etc.). Second interview: One week after the first interview, at the appointed location (ASM and the participant's home), the "Sleep Hygiene Training" prepared according to the individual characteristics - experiences and behavior-specific cognitive processes and behavioral outputs that are the components of the SGM was carried out, the "Sleep Diary" was introduced, the "Sleep Hygiene Training Booklet" and the "Sleep Diary" were distributed. Third interview: One week after the second interview, the repeat training, which constitutes the second session of the training, was carried out. Fourth interview: Obtaining the post-test data 4 weeks after the second interview. The researcher reminded the participants about the sleep diary via text |
| control group | No intervention | –A total of two interviews were conducted with women in the control group who were not given any intervention. In the first interview, pre-test data were obtained using the Personal Introduction Form, MSDS and PSQI. In the interview held 6 weeks after the first interview, post-test data were obtained using MSDS and PSQI. Each interview lasted an average of 15-20 minutes. |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Not having menstrual bleeding for at least 12 consecutive months
- Not having difficulty communicating
- Using a mobile phone
- Being literate
- Not using sleeping pills
Key exclusion criteria (2 listed)
- Menstrual bleeding during the research period
- The participant wants to talk about his/her research.
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 educationThis study will be conducted to examine the effects of sleep hygiene training, which is given to women in menopause to eliminate sleep problems and menopause symptoms that they often experience, on sleep and menopause symptoms experienced by women. | Behavioural | training group |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: first day encountered
It was developed by Buysse et al. (1989) to assess sleep quality. It was adapted to Turkish by Ağargün et al. in 1996. The PSQI assesses the quality of an individual's sleep in the last month. While the individual answers 19 of the 24 questions in the PSQI, 5 questions are expected to be answered by the spouse or a roommate. The last 5 questions are directed only to the individual's relative in terms of clinical aspects and are not included in the scoring. The last of the questions asked as self-report questions is whether the individual has a roommate or spouse; this question is not used in the evaluation of the PSQI. There are different factors related to sleep quality in the self-report questions. The 18 items included in the scoring are divided into groups as 7 component scores. Some of the components are shown with only one item, while the other results in the classification of several items. Each component in the questions is worth 0-3 points.
Menopausal Symptoms Assessment Scale
Time frame: first day encountered
MSDÖ, developed by Schneider and colleagues in German to determine the level of menopause experienced by women, was translated and adapted into Turkish by Gürkan in 2005. The Likert-type scale consists of a total of 11 items covering menopausal complaints. Each item has three sub-dimensions, with the options 0: none at all, 1: mild, 2: moderate, 3: severe and 4: very severe. These are; 1. Somatic symptoms sub-dimension: items 1, 2, 3, 11 2. Psychological symptoms sub-dimension: items 4, 5, 6, 7 3. Urogenital symptoms sub-dimension: items 8, 9, 10. The total score of the scale is calculated according to the scores given to each item. The lowest score on the scale is 0, and the highest score is 44. A high total score calculated at the end of the scale indicates that the participant has many complaints and that their standard of living is negatively affected.
2 secondary outcomes
pittsburg sleep index
Time frame: up to 4 weeks after registration
Menopausal Symptoms Assessment Scale
Time frame: up to 4 weeks after registration
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 1 Apr 2026.
- Individual participant dataSharing planned: Yes. all IPD underlying results in a publication
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep hygiene education in people with Absence of Menstrual Bleeding for at Least 12 Consecutive Months and No Communication Difficulties, run by Inonu University at 1 site 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 6 inclusion and 2 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 1 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 1 site 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?
Pittsburgh Sleep Quality Index (time frame: first day encountered). 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 1 Apr 2026.