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

NCT06750562 | Completed

• 1 other identifier: 913715751
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Sleep

Outcome Measures

Primary Outcomes (3)

• Pittsburgh Sleep Quality Index (PSQI)

  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)

  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)

  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

Study Arms (2)

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.

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.

Interventions

interactive game BEHAVIORAL

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.

experimental intervention

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: in menopause
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Meryem Vural Şahin: lead

Study Sites (1)

University of Health Sciences Gülhane Faculty of Health Sciences

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 38680214 BACKGROUND

• Vazquez 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.

  PMID: 30533015 BACKGROUND

• Chung 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.

  PMID: 29194467 BACKGROUND

• Kalmbach 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.

  PMID: 31383238 BACKGROUND

• Abdelaziz 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.

  PMID: 35414619 BACKGROUND

• Johnson 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.

  PMID: 30868921 BACKGROUND

• Schaedel 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.

  PMID: 34748453 BACKGROUND

• Song 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.

  PMID: 35983252 BACKGROUND

• Tandon 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.

  PMID: 35707298 BACKGROUND

• Lucena 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.

  PMID: 37495431 BACKGROUND

• Ha 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.

  PMID: 36766902 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHD Student

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 27, 2024
• Study Start: July 28, 2025
• Primary Completion: September 27, 2025
• Study Completion: November 30, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)