Clinical trial NCT06750562: The Effect of Interactive Game Supported Sleep Hygiene Training on Sleep Quality, Menopausal Symptoms and Quality of Life in Menopausal Women
Official title: The Effect of Interactive Game Supported Sleep Hygiene Training on Sleep Quality, Menopausal Symptoms and Quality of Life in Menopausal Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menopause
Sleep
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 78
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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
* Natural menopause
* Not working in a shift job
* Having the appropriate devices to play the game (computer, smartphone and internet connection)

Exclusion Criteria:

* - 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

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 month after the training and interactive game application
measure: Menopause Symptoms Assessment Scale (MSAS)
timeFrame: 1 month after the training and interactive game
measure: Menopause Specific Quality of Life Scale (MSQOL)
timeFrame: 1 month after the training and interactive game application
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Gülhane Faculty of Health Sciences
Study officials:
References:
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