MenopauseNCT06750562
The Effect of Interactive Game Supported Sleep Hygiene Training on Sleep Quality, Menopausal Symptoms and Quality of Life in Menopausal Women
A study testing interactive game in people with Menopause and Sleep, run by Meryem Vural Şahin at 1 site in Turkey (Türkiye).
Trial summary
This study will present an innovative approach for sleep hygiene education in this age group by developing an interactive game-based education model for menopausal women. Gamification methods enable education to be made more interactive, engaging and fun, which can improve the learning process. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- What is being tested?
- interactive game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2025to 30 Nov 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Score >5 according to the PDCI
- No problem in speaking and understanding Turkish
- Being in the menopausal period between the ages of 40-60
- Not having a systemic disease (rheumatoid arthritis, multiple sclerosis, etc.).
- Volunteering to participate in the study
- Absence of menstruation in the last 12 months
Show all 9Show fewer
- Natural menopause
- Not working in a shift job
- Having the appropriate devices to play the game (computer, smartphone and internet connection)
Who cannot join
- - Receiving Hormone Replacement Therapy
- Diagnosed psychiatric illness
- Receiving a cancer diagnosis
- Entering menopause for surgical reasons
- Presence of chronic pain
- Diagnosis of a sleep disorder
- Receiving pharmacological or nonpharmacological treatment for sleep disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Gülhane Faculty of Health Sciences
Ankara, 06018
About this study
This study will present an innovative approach for sleep hygiene education in this age group by developing an interactive game-based education model for menopausal women. Gamification methods enable education to be made more interactive, engaging and fun, which can improve the learning process. Considering the lack of such an application in the literature, this study is thought to fill a gap both in Turkey and worldwide. While health education is usually presented with classical methods, interactive gamification methods have attracted more attention in recent years. This study is thought to be one of the first to show how gamification can be used in menopausal women. In addition, the findings of the study may show that improving sleep hygiene in the menopausal period may provide positive effects not only on sleep quality, but also on menopausal symptoms and overall quality of life. Therefore, it is thought that the study may provide critical data in both symptom management and women's health. It is thought that this study will pioneer the development of new education and counselling models in the field of midwifery. Especially midwives can take a more effective role in symptom management by using such interactive trainings for women in menopausal period. Thus, it is thought that an innovative approach will be brought to midwifery education and practices.
Read the detailed description
Sleep hygiene training requires the acquisition and practice of specific behaviours, but is typically delivered in a single meeting with a practitioner. Such formats may not encourage participation or provide opportunities to review and practice behaviours. An alternative format, game-based learning, provides interaction with activities that have a clear set of objectives, constraints and rules. The digital game creates an individual communication environment that incorporates the digitality, interactivity, virtuality, variability, modularity features of the new communication environment and incorporates these features into the act of playing games. Compared to traditional education, game-based education provides situated learning as it can mimic the real world in which the learner is situated. In educational research, it is emphasised that the game factor increases motivation. In a meta-analysis of 22 studies on video game-based interventions targeting healthy adults older than 44 years, it was found that video game-based interventions had positive effects on objectively measured physical and social health.
Midwives play a critical role in meeting basic human needs and supporting the independence of individuals. One of the most basic needs of menopausal women is the need for sleep. However, in the national and international literature, there is no interactive game-supported web-based sleep hygiene training application for menopausal women. This situation reveals the need to develop an innovative approach in which midwives can provide more effective education and counselling in symptom management. Interactive game-based education was planned to provide a new and effective method to support women's health by increasing knowledge about sleep hygiene in menopausal women and to strengthen the role of midwives in this process.
- Being tested
- interactive game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive gameBehavioural
Interactive game supported sleep hygiene will be prepared by researchers. The game will be shared after each sleep hygiene training. The intervention is planned as 4 trainings and 4 games in total.
| Study group | Role | What they receive |
|---|---|---|
| experimental intervention | Experimental | This group will receive online sleep hygiene training for 4 weeks. The training will be given one day a week and last 30 minutes.
is foreseen. After each training, an interactive sleep hygiene game will be shared online. A total of 4 interactive sleep hygiene games will be shared. The total duration of a game will not exceed 20 minutes. Receives: Behavioral: interactive game |
| control group | No intervention | this group will be given online sleep hygiene training once a week for a total of 4 weeks. The duration of each training will not exceed 30 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The total score varies between 0-21. A total score higher than 5 indicates 'poor sleep quality'.
Measured: 1 month after the training and interactive game application
Menopause Symptoms Assessment Scale (MSAS)
The lowest score of 0 (zero) and the highest score of 44 (forty-four) can be obtained from the MSAS. The increase in the total number of points of the scale reveals an increase in the severity of menopausal symptoms in women experiencing menopausal symptoms.
Measured: 1 month after the training and interactive game
Menopause Specific Quality of Life Scale (MSQOL)
The lowest score that can be obtained from the total scale is '0' and the highest score (29X6) is 154.
Measured: 1 month after the training and interactive game application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start28 Jul 2025
- Primary completion27 Sep 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meryem Vural Şahin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meryem Vural Şahin, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750562
- Sponsor's protocol ID
- 913715751
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seaver C, Bowers C, Beidel D, Holt L, Ramakrishnan S. A game-based learning approach to sleep hygiene education: a pilot investigation. Front Digit Health. 2024 Apr 12;6:1334840. doi: 10.3389/fdgth.2024.1334840. eCollection 2024.
PubMed 38680214Vazquez FL, Otero P, Garcia-Casal JA, Blanco V, Torres AJ, Arrojo M. Efficacy of video game-based interventions for active aging. A systematic literature review and meta-analysis. PLoS One. 2018 Dec 11;13(12):e0208192. doi: 10.1371/journal.pone.0208192. eCollection 2018.
PubMed 30533015Chung KF, Lee CT, Yeung WF, Chan MS, Chung EW, Lin WL. Sleep hygiene education as a treatment of insomnia: a systematic review and meta-analysis. Fam Pract. 2018 Jul 23;35(4):365-375. doi: 10.1093/fampra/cmx122.
PubMed 29194467Kalmbach DA, Cheng P, Arnedt JT, Cuamatzi-Castelan A, Atkinson RL, Fellman-Couture C, Roehrs T, Drake CL. Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education. J Clin Sleep Med. 2019 Jul 15;15(7):999-1010. doi: 10.5664/jcsm.7882.
PubMed 31383238Abdelaziz EM, Elsharkawy NB, Mohamed SM. The relationship between sleep quality and menopausal symptoms among postmenopausal women in Saudi Arabia. Saudi Med J. 2022 Apr;43(4):401-407. doi: 10.15537/smj.2022.43.4.20210682.
PubMed 35414619Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.
PubMed 30868921Schaedel Z, Holloway D, Bruce D, Rymer J. Management of sleep disorders in the menopausal transition. Post Reprod Health. 2021 Dec;27(4):209-214. doi: 10.1177/20533691211039151. Epub 2021 Nov 8.
PubMed 34748453Song Z, Jiang R, Li C, Jin F, Tao M. Menopausal Symptoms and Sleep Quality in Women Aged 40-65 Years. Biomed Res Int. 2022 Aug 9;2022:2560053. doi: 10.1155/2022/2560053. eCollection 2022.
PubMed 35983252Tandon VR, Sharma S, Mahajan A, Mahajan A, Tandon A. Menopause and Sleep Disorders. J Midlife Health. 2022 Jan-Mar;13(1):26-33. doi: 10.4103/jmh.jmh_18_22. Epub 2022 May 2.
PubMed 35707298Lucena L, Santos-Junior JG, Tufik S, Hachul H. Effect of a lavender essential oil and sleep hygiene protocol on insomnia in postmenopausal women: A pilot randomized clinical trial. Explore (NY). 2024 Jan-Feb;20(1):116-125. doi: 10.1016/j.explore.2023.07.004. Epub 2023 Jul 17.
PubMed 37495431Ha B, Kim J, So WY, Kim S. Effects of Nonpharmacological Interventions on Sleep Quality and Insomnia in Perimenopausal and Postmenopausal Women: A Meta-Analysis. Healthcare (Basel). 2023 Jan 22;11(3):327. doi: 10.3390/healthcare11030327.
PubMed 36766902
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interactive Game Supported Sleep Hygiene Training on Sleep Quality, Menopausal Symptoms and Quality of Life in Menopausal Women
- ClinicalTrials.gov ID
- NCT06750562
- Acronym / sponsor ID
- 913715751
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Meryem Vural ŞahinUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 27 Sep 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 27 Dec 2024 (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.
This study will present an innovative approach for sleep hygiene education in this age group by developing an interactive game-based education model for menopausal women. Gamification methods enable education to be made more interactive, engaging and fun, which can improve the learning process. Considering the lack of such an application in the literature, this study is thought to fill a gap both in Turkey and worldwide. While health education is usually presented with classical methods, interactive gamification methods have attracted more attention in recent years. This study is thought to be one of the first to show how gamification can be used in menopausal women. In addition, the findings of the study may show that improving sleep hygiene in the menopausal period may provide positive effects not only on sleep quality, but also on menopausal symptoms and overall quality of life. Therefore, it is thought that the study may provide critical data in both symptom management and women's health. It is thought that this study will pioneer the development of new education and counselling models in the field of midwifery. Especially midwives can take a more effective role in symptom management by using such interactive trainings for women in menopausal period. Thus, it is thought that an innovative approach will be brought to midwifery education and practices.
Detailed description
Sleep hygiene training requires the acquisition and practice of specific behaviours, but is typically delivered in a single meeting with a practitioner. Such formats may not encourage participation or provide opportunities to review and practice behaviours. An alternative format, game-based learning, provides interaction with activities that have a clear set of objectives, constraints and rules. The digital game creates an individual communication environment that incorporates the digitality, interactivity, virtuality, variability, modularity features of the new communication environment and incorporates these features into the act of playing games. Compared to traditional education, game-based education provides situated learning as it can mimic the real world in which the learner is situated. In educational research, it is emphasised that the game factor increases motivation. In a meta-analysis of 22 studies on video game-based interventions targeting healthy adults older than 44 years, it was found that video game-based interventions had positive effects on objectively measured physical and social health.
Midwives play a critical role in meeting basic human needs and supporting the independence of individuals. One of the most basic needs of menopausal women is the need for sleep. However, in the national and international literature, there is no interactive game-supported web-based sleep hygiene training application for menopausal women. This situation reveals the need to develop an innovative approach in which midwives can provide more effective education and counselling in symptom management. Interactive game-based education was planned to provide a new and effective method to support women's health by increasing knowledge about sleep hygiene in menopausal women and to strengthen the role of midwives in this process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental intervention | Experimental | Behavioral: interactive gameThis group will receive online sleep hygiene training for 4 weeks. The training will be given one day a week and last 30 minutes. is foreseen. After each training, an interactive sleep hygiene game will be shared online. A total of 4 interactive sleep hygiene games will be shared. The total duration of a game will not exceed 20 minutes. |
| control group | No intervention | –this group will be given online sleep hygiene training once a week for a total of 4 weeks. The duration of each training will not exceed 30 minutes. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Score >5 according to the PDCI
- No problem in speaking and understanding Turkish
- Being in the menopausal period between the ages of 40-60
- Not having a systemic disease (rheumatoid arthritis, multiple sclerosis, etc.).
- Volunteering to participate in the study
Key exclusion criteria (7 listed)
- - Receiving Hormone Replacement Therapy
- Diagnosed psychiatric illness
- Receiving a cancer diagnosis
- Entering menopause for surgical reasons
- Presence of chronic pain
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 |
|---|---|---|
| interactive gameInteractive game supported sleep hygiene will be prepared by researchers. The game will be shared after each sleep hygiene training. The intervention is planned as 4 trainings and 4 games in total. | Behavioural | experimental intervention |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 month after the training and interactive game application
The total score varies between 0-21. A total score higher than 5 indicates 'poor sleep quality'.
Menopause Symptoms Assessment Scale (MSAS)
Time frame: 1 month after the training and interactive game
The lowest score of 0 (zero) and the highest score of 44 (forty-four) can be obtained from the MSAS. The increase in the total number of points of the scale reveals an increase in the severity of menopausal symptoms in women experiencing menopausal symptoms.
Menopause Specific Quality of Life Scale (MSQOL)
Time frame: 1 month after the training and interactive game application
The lowest score that can be obtained from the total scale is '0' and the highest score (29X6) is 154.
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 6 Jan 2026.
- Background: PubMed 38680214Seaver C, Bowers C, Beidel D, Holt L, Ramakrishnan S. A game-based learning approach to sleep hygiene education: a pilot investigation. Front Digit Health. 2024 Apr 12;6:1334840. doi: 10.3389/fdgth.2024.1334840. eCollection 2024.
- Background: PubMed 30533015Vazquez FL, Otero P, Garcia-Casal JA, Blanco V, Torres AJ, Arrojo M. Efficacy of video game-based interventions for active aging. A systematic literature review and meta-analysis. PLoS One. 2018 Dec 11;13(12):e0208192. doi: 10.1371/journal.pone.0208192. eCollection 2018.
- Background: PubMed 29194467Chung KF, Lee CT, Yeung WF, Chan MS, Chung EW, Lin WL. Sleep hygiene education as a treatment of insomnia: a systematic review and meta-analysis. Fam Pract. 2018 Jul 23;35(4):365-375. doi: 10.1093/fampra/cmx122.
- Background: PubMed 31383238Kalmbach DA, Cheng P, Arnedt JT, Cuamatzi-Castelan A, Atkinson RL, Fellman-Couture C, Roehrs T, Drake CL. Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education. J Clin Sleep Med. 2019 Jul 15;15(7):999-1010. doi: 10.5664/jcsm.7882.
- Background: PubMed 35414619Abdelaziz EM, Elsharkawy NB, Mohamed SM. The relationship between sleep quality and menopausal symptoms among postmenopausal women in Saudi Arabia. Saudi Med J. 2022 Apr;43(4):401-407. doi: 10.15537/smj.2022.43.4.20210682.
- Background: PubMed 30868921Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.
- Background: PubMed 34748453Schaedel Z, Holloway D, Bruce D, Rymer J. Management of sleep disorders in the menopausal transition. Post Reprod Health. 2021 Dec;27(4):209-214. doi: 10.1177/20533691211039151. Epub 2021 Nov 8.
- Background: PubMed 35983252Song Z, Jiang R, Li C, Jin F, Tao M. Menopausal Symptoms and Sleep Quality in Women Aged 40-65 Years. Biomed Res Int. 2022 Aug 9;2022:2560053. doi: 10.1155/2022/2560053. eCollection 2022.
- Background: PubMed 35707298Tandon VR, Sharma S, Mahajan A, Mahajan A, Tandon A. Menopause and Sleep Disorders. J Midlife Health. 2022 Jan-Mar;13(1):26-33. doi: 10.4103/jmh.jmh_18_22. Epub 2022 May 2.
- Background: PubMed 37495431Lucena L, Santos-Junior JG, Tufik S, Hachul H. Effect of a lavender essential oil and sleep hygiene protocol on insomnia in postmenopausal women: A pilot randomized clinical trial. Explore (NY). 2024 Jan-Feb;20(1):116-125. doi: 10.1016/j.explore.2023.07.004. Epub 2023 Jul 17.
- Background: PubMed 36766902Ha B, Kim J, So WY, Kim S. Effects of Nonpharmacological Interventions on Sleep Quality and Insomnia in Perimenopausal and Postmenopausal Women: A Meta-Analysis. Healthcare (Basel). 2023 Jan 22;11(3):327. doi: 10.3390/healthcare11030327.
- 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.
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 interactive game in people with Menopause and Sleep, run by Meryem Vural Şahin 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 9 inclusion and 7 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 6 Jan 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 (PSQI) (time frame: 1 month after the training and interactive game application). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750562, which also lists 11 linked publications.
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 6 Jan 2026.