The Effect of Interactive Game Supported Sleep Hygiene Training on Sleep Quality, Menopausal Symptoms and Quality of Life in Menopausal Women

January 4, 2026 updated by: Meryem Vural Şahin
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06018
        • University of Health Sciences Gülhane Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental intervention

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.
Behavioral: interactive game
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.
No Intervention: control group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
1 month after the training and interactive game application
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.
1 month after the training and interactive game
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.
1 month after the training and interactive game application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meryem Vural Şahin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2025

Primary Completion (Actual)

September 27, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 913715751

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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